Dry skin, Sleep disorder, Pruritus +2
Drugs: DUPIXENT, ALPRAZOLAM, CLONAZEPAM +8
- Safetyreportversion
- 1
- Safetyreportid
- 27325234
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20261008
- Reporttype
- 1
- Serious
- 2
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 2
- Companynumb
- US-SA-2026SA0222362
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- SANOFI AVENTIS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientagegroup
- 5
- Patientweight
- 63.503
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Dry skin
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Sleep disorder
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Pruritus
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Skin exfoliation
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Drug ineffective
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- DUPIXENT
- Drugbatchnumb
- 5F826A
- Drugauthorizationnumb
- 761055
- Drugstructuredosagenumb
- 300
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 2
- Drugintervaldosagedefinition
- 803
- Drugdosagetext
- 300.000MG QOW
- Drugindication
- Dermatitis atopic
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Activesubstance
- Activesubstancename
- DUPILUMAB
- Harmonized identifiers (openFDA)
- Application number
- BLA761055
- Brand name
- DUPIXENT
- Generic name
- DUPILUMAB
- Manufacturer name
- Sanofi-Aventis U.S. LLC
- Product NDC
- 0024-5914, 0024-5918, 0024-5915, 0024-5919
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- SUBCUTANEOUS
- Substance name
- DUPILUMAB
- RxCUI
- 1876401, 1876406, 2099300, 2099302, 2375327, 2375329, 2559706, 2559707
- SPL ID
- 06b9c64b-52b1-490b-b118-bd079e69264e
- SPL set ID
- 595f437d-2729-40bb-9c62-c8ece1f82780
- Package NDC
- 0024-5914-00, 0024-5914-01, 0024-5914-20, 0024-5914-02, 0024-5918-00, 0024-5918-01, 0024-5918-20, 0024-5918-02, 0024-5915-00, 0024-5915-02, 0024-5915-01, 0024-5915-20, 0024-5919-00, 0024-5919-02, 0024-5919-01, 0024-5919-20
- Nui
- N0000193342, N0000193341, M0001357
- Pharm class epc
- Interleukin-4 Receptor alpha Antagonist [EPC]
- Pharm class moa
- Interleukin 4 Receptor alpha Antagonists [MoA]
- Pharm class cs
- Antibodies, Monoclonal [CS]
- UNII
- 420K487FSG
- Drugcharacterization
- 2
- Medicinalproduct
- ALPRAZOLAM
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- ALPRAZOLAM
- Harmonized identifiers (openFDA)
- Application number
- ANDA074342, ANDA203346, ANDA090871, NDA018276, ANDA074174, ANDA078088, ANDA078561, ANDA078387, ANDA200739, NDA021434, ANDA074312, ANDA074112, ANDA074909
- Brand name
- ALPRAZOLAM, XANAX, ALPRAZOLAM XR
- Generic name
- ALPRAZOLAM
- Manufacturer name
- Actavis Pharma, Inc., Aurobindo Pharma Limited, Mylan Pharmaceuticals Inc., ANI Pharmaceuticals, Inc., Par Health USA, LLC, Amneal Pharmaceuticals LLC, Natco Pharma USA LLC, PHARMACIA & UPJOHN COMPANY LLC, Hikma Pharmaceuticals USA Inc., Sandoz Inc
- Product NDC
- 0228-2027, 0228-2029, 0228-2031, 0228-2039, 65862-676, 65862-677, 65862-678, 65862-679, 65862-454, 65862-455, 65862-456, 65862-457, 59762-3719, 59762-3720, 59762-3721, 59762-3722, 70954-508, 70954-509, 70954-510, 70954-511, 49884-110, 49884-111, 49884-213, 49884-214, 0228-4019, 0228-4022, 0228-4024, 0228-4025, 65162-809, 65162-810, 65162-812, 65162-813, 69339-199, 69339-200, 69339-201, 69339-202, 0009-0029, 0009-0055, 0009-0090, 0009-0094 +9 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- ALPRAZOLAM
- RxCUI
- 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 485413, 485414, 485415, 485416, 141927, 141928, 214003, 214004, 308050
- SPL ID
- 08d09d46-386d-4dc8-a0c1-5711261c6282, 7527aeb7-8912-404d-afb7-8c692c84422b, f2273fea-bd3b-4ef5-b698-73ba677722e3, 0deddc26-2764-4879-a0e4-a29fff246244, 18a6f29f-7eb8-4aa2-8121-d554c59da191, 38e94d5e-f7e2-4349-94f2-2fba605f5ae6, 38c5b407-25a1-48f5-960e-87ef637b644c, 4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91, 885d0fec-f1a6-42f4-8617-1d048cb15ee9, f5323eac-81d0-4096-ac15-2f25220c5c28, 70f0098e-50b5-4e61-b4e0-141a55d92267, d7b8cdff-1337-4ef6-a5fb-654f1d655bfe, 4c8c7366-aa3b-4124-9d64-67fb0ead6e15
- SPL set ID
- a23063c0-099a-4256-b95f-3a857bbf704b, d2fd0b3e-9b78-44d0-82a6-96d6c6238750, 326fa31a-5420-429b-9f7f-170cb38f64bd, 13930c94-d83a-414f-be35-b1fef35f738d, 38428a1b-718c-49cc-94ae-2e3644ba6256, ff1630b4-2044-433c-96bc-0bb4ae8d42a0, 5ceed721-2e65-4c81-bd84-f110b1ac9d2e, 259387c1-e374-4bc2-9510-5f7f2c60d1a5, b3c55877-2538-4892-bdb1-d618c643d29c, 388e249d-b9b6-44c3-9f8f-880eced0239f, 1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3, b945ac6f-796e-41ef-85e9-61007e4a4e9a, d9b0e228-17cf-40d7-b62e-5050311c571c
- Package NDC
- 0228-2027-10, 0228-2027-50, 0228-2027-96, 0228-2029-10, 0228-2029-50, 0228-2029-96, 0228-2031-10, 0228-2031-50, 0228-2031-96, 0228-2039-10, 65862-676-01, 65862-676-05, 65862-676-99, 65862-677-01, 65862-677-05, 65862-677-99, 65862-678-01, 65862-678-05, 65862-678-99, 65862-679-01, 65862-679-05, 65862-679-99, 65862-454-60, 65862-454-99, 65862-454-71, 65862-455-60, 65862-455-99, 65862-455-71, 65862-456-60, 65862-456-99, 65862-456-71, 65862-457-60, 65862-457-99, 65862-457-71, 59762-3719-1, 59762-3719-3, 59762-3719-4, 59762-3720-1, 59762-3720-3, 59762-3720-4 +77 more
- Nui
- N0000175694, M0002356
- Pharm class epc
- Benzodiazepine [EPC]
- Pharm class cs
- Benzodiazepines [CS]
- UNII
- YU55MQ3IZY
- Drugcharacterization
- 2
- Medicinalproduct
- CLONAZEPAM
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- CLONAZEPAM
- Harmonized identifiers (openFDA)
- Application number
- ANDA075468, ANDA077194, ANDA077171, ANDA074569, ANDA075150, ANDA077147, ANDA216988, ANDA074925, ANDA211033, ANDA077856, NDA017533
- Brand name
- CLONAZEPAM, KLONOPIN
- Generic name
- CLONAZEPAM
- Manufacturer name
- Advagen Pharma Ltd, Teva Pharmaceuticals USA, Inc., Par Health USA, LLC, Aurobindo Pharma Limited, Accord Healthcare Inc., Chartwell RX, LLC, Alembic Pharmaceuticals Inc., Solco Healthcare LLC, Alembic Pharmaceuticals Limited, H2-Pharma, LLC, Northstar Rx LLC
- Product NDC
- 72888-152, 72888-497, 72888-153, 72888-154, 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 0093-3213, 59651-722, 59651-723, 59651-724, 16729-136, 16729-137, 16729-138, 72888-133, 72888-134, 72888-135, 72888-136, 72888-137, 62135-769, 62135-770, 62135-771, 62332-364, 62332-365, 62332-366, 62332-367, 62332-368, 43547-406, 43547-407, 43547-408, 46708-364 +10 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- CLONAZEPAM
- RxCUI
- 197527, 197528, 197529, 204892, 349194, 349195, 349196, 349197, 349198, 206157, 206159, 206160
- SPL ID
- 5510f17b-a980-f412-e063-6394a90ae1c4, a2f2eb5b-f890-4d6d-b728-5f63eb7dc11c, cb847105-dbbe-4e7a-ab2b-ad0731638ce6, d6abe4e3-7699-4ead-95f4-739a961b23ad, b1582eb7-af35-45d5-a52e-0e380d08527d, 0e1e7f41-f78b-27cf-e063-6394a90a1ae0, 52c6d077-2562-84e0-e063-6394a90ae280, 09184e1a-1808-d656-e063-6294a90aa6f8, f619cc4e-e90b-4683-8959-864afafb3c44, dc17b9d4-2890-4f6c-8476-daa39d0cbc9c, e19dd42d-3043-4605-9adf-001741e03942, 63cfdab9-fb3d-4c2b-bf88-8ba841dba839, 4764ed40-0c42-835c-e063-6394a90a9b68
- SPL set ID
- 30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec, cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, b1582eb7-af35-45d5-a52e-0e380d08527d, ebc11109-e7bf-452d-b675-4b3236d54164, 19fc756c-72fe-4504-beaa-4fa2235af18c, 7b543f77-4388-4227-942f-7933f200b3a5, ecb28fcb-f0d1-4558-b460-ecabd0f6009e, 4acbb7a9-4db5-4497-b8db-9f358b3f6fb4, 43ee20ce-0015-413c-b230-822e390b02f7, cfa0d79a-843c-4b88-95a1-e9511d649ca1, 017534e6-49ff-45f3-b88f-2f34cf0cf8fd
- Package NDC
- 72888-497-01, 72888-497-02, 72888-497-03, 72888-497-04, 72888-152-30, 72888-152-01, 72888-152-05, 72888-152-00, 72888-153-30, 72888-153-01, 72888-153-05, 72888-153-00, 72888-154-30, 72888-154-01, 72888-154-05, 72888-154-00, 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832-01, 0093-0832-05, 0093-3212-01, 0093-3212-05, 0093-3213-01, 0093-3213-05, 59651-722-01, 59651-722-99, 59651-723-01, 59651-723-99, 59651-724-01, 59651-724-05, 16729-136-00, 16729-136-16 +45 more
- Nui
- N0000175694, M0002356
- Pharm class epc
- Benzodiazepine [EPC]
- Pharm class cs
- Benzodiazepines [CS]
- UNII
- 5PE9FDE8GB
- Drugcharacterization
- 2
- Medicinalproduct
- EUCERIN
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- ENSULIZOLE\EUCERIN\OCTINOXATE\OCTISALATE\TITANIUM DIOXIDE\ZINC OXIDE
- Drugcharacterization
- 2
- Medicinalproduct
- FLUPHENAZINE HYDROCHLORIDE
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- FLUPHENAZINE HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA218173, ANDA214674, ANDA215674, ANDA218055, ANDA089556, ANDA074725, ANDA217189, ANDA218283, ANDA215141, ANDA213647, ANDA214534, ANDA213784, ANDA217410, ANDA214552, ANDA089743, ANDA040146, ANDA216350, ANDA218769, ANDA215848
- Brand name
- FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHORIDE
- Generic name
- FLUPHENAZINE HYDROCHLORIDE
- Manufacturer name
- Alembic Pharmaceuticals Limited, ANI Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., Aurobindo Pharma Limited, Fresenius Kabi USA, LLC, PAI Holdings, LLC dba PAI Pharma, Novadoz Pharmaceuticals LLC, Rising Pharma Holdings, Inc., Zameer Pharmaceuticals LLC, Amneal Pharmaceuticals NY LLC, Chartwell RX, LLC, Dr. Reddys Laboratories Inc., Upsher-Smith Laboratories,LLC, Ajanta Pharma USA Inc., Zydus Pharmaceuticals (USA) Inc., Lannett Company, Inc., Zydus Lifesciences Limited, Glenmark Pharmaceuticals Inc., USA, Camber Pharmaceuticals, Inc., Upsher-Smith Laboratories, LLC, Alembic Pharmaceuticals Inc.
- Product NDC
- 46708-788, 46708-789, 46708-790, 46708-791, 70954-273, 70954-274, 70954-275, 70954-276, 51672-4233, 51672-4234, 51672-4235, 51672-4236, 59651-686, 59651-687, 59651-688, 59651-689, 63323-281, 0121-0653, 72205-112, 72205-113, 72205-114, 72205-115, 16571-889, 16571-890, 16571-891, 16571-892, 90096-121, 90096-122, 90096-123, 90096-124, 69238-1678, 69238-1679, 69238-1680, 69238-1681, 62135-415, 62135-416, 62135-418, 62135-419, 43598-034, 43598-035 +39 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAMUSCULAR
- Substance name
- FLUPHENAZINE HYDROCHLORIDE
- RxCUI
- 859841, 860918, 865117, 865123, 865129, 861848, 859835
- SPL ID
- 7c29fb1f-9403-4e55-abd9-36adfb152e8e, b62e66ce-9c80-46f1-bb86-68f7f73c487c, 4db5cdb5-b848-695f-e063-6294a90a25b5, 1109b107-f7af-45b7-b8ee-709c59123074, cefdb059-d32b-44f2-8dd6-fd2a29b3ba70, 4bf945f4-e607-409c-80f5-90195005d6a7, f99e9ea5-3c4a-4a94-9ca9-709f65b8fd82, 5e7076f6-426b-45c2-865f-7be79fe81205, bba99290-dad3-4e82-960e-bf274eb5e4b8, e350dbeb-6212-43b1-8c85-f60fb1719e0f, 458c6457-ed15-15f4-e063-6294a90acc6d, 95c5a977-cf1e-488a-8eff-c5fabc4b73c3, 3bb74f82-8872-9829-e063-6294a90aeace, 0069bda4-a743-4edd-a15f-a53cba1a2bff, 130b45fa-6dbd-46cc-a937-ab8ef1ec0718, 59cf1ea7-b827-4780-bf94-cd3446d6dcc3, 1db40261-ae57-4539-a7e9-7ca75d96627a, be2cdaa4-74b5-4256-90c0-e1410973b3f5, b5186569-6be5-4ff2-a95e-f162f76254d9, 4468c081-e6a4-bbbf-e063-6294a90aa886, e2589baf-4d61-4d50-a578-41c51fbb6deb, f7ef2923-6d2a-4b1f-ad9c-c8127391b9f4
- SPL set ID
- 7c29fb1f-9403-4e55-abd9-36adfb152e8e, 6218cbd2-1f7f-40fa-92d2-5d5b0d7fa60b, 7036f7c6-0792-400d-a1c7-54f21b2bd481, e73764e7-e666-4ad3-a029-04a528dc1c9e, d571f04f-6190-42f2-932c-5a075fd978b9, 0860b3f3-3116-40f8-bcb0-e5c47731bdc8, 83ce71b9-28eb-4074-b1e7-192ed254c529, 9fd44ab9-79bb-472e-8434-c3d786b42de5, d9db3882-a7b5-435b-9d5a-a5e4ef7c2537, 5b443b30-5682-4cf3-9ed0-716efddbc865, 325af2a4-2280-4236-8cf8-44f5700ba73f, 98aeddfd-4f24-4d1a-820d-d0abc1733794, f07bb3f1-c68c-441b-9de4-99a219f2500a, 47695e20-9c0b-4a6b-ab1a-1dfaa75e96d8, c4448579-3ccb-442e-8950-a219d1f01a98, 6cd6ba35-3481-48c1-87db-dc74ce9d7d75, 977dc369-6b6d-4ad1-9239-a46f63a764bd, f0a89d5d-01db-47f3-a873-33ab49c6e4f8, 4c3eea71-a7a1-4eda-9871-034ddeb83ed6, 4dd61338-8e4b-41c6-99d8-811a8e990c4e, d0a090fa-f7c9-4f6d-a9a3-9838870c7049, 1991be2c-9629-4c3e-93f0-e40bcffc82b0
- Package NDC
- 46708-788-31, 46708-788-71, 46708-789-31, 46708-789-71, 46708-790-31, 46708-790-71, 46708-791-31, 46708-791-71, 70954-273-10, 70954-274-10, 70954-275-10, 70954-275-20, 70954-276-10, 70954-276-20, 51672-4233-1, 51672-4234-1, 51672-4235-1, 51672-4236-1, 59651-686-01, 59651-687-01, 59651-688-01, 59651-688-05, 59651-689-01, 59651-689-05, 63323-281-10, 0121-0653-04, 72205-113-91, 72205-113-05, 72205-114-91, 72205-114-05, 72205-115-91, 72205-115-05, 72205-112-91, 72205-112-05, 16571-889-09, 16571-889-50, 16571-890-09, 16571-890-50, 16571-891-09, 16571-891-50 +84 more
- UNII
- ZOU145W1XL
- Drugcharacterization
- 2
- Medicinalproduct
- IBUPROFEN
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- IBUPROFEN
- Harmonized identifiers (openFDA)
- Application number
- ANDA078682, ANDA077349, 505G(a)(3), ANDA079174, ANDA074937, ANDA210602, ANDA202312, ANDA075217, ANDA091355, ANDA075010, ANDA076359, ANDA209179, ANDA210755, NDA020944, ANDA091239, ANDA075682, NDA020589, ANDA202413, ANDA091237, NDA020516, ANDA210149, ANDA072096, ANDA207095, ANDA220239, ANDA206568, ANDA217261, ANDA204469, ANDA207753, ANDA079233, ANDA079205, ANDA206999, ANDA075139, NDA020402, ANDA213794, NDA022348, ANDA079129, ANDA215318, ANDA208865, M, ANDA078329 +30 more
- Brand name
- IBUPROFEN, CAREONE IBUPROFEN, GOOD REMEDIES IBUPROFEN 200 MG, IBUPROFEN CHILDRENS, CHILDRENS IBUPROFEN ORAL SUSPENSION, DYE FREE, INFANTS DYE FREE IBUPROFEN, LEADER CHILDRENS IBUPROFEN, GOOD SENSE CHILDRENS IBUPROFEN, CABINET PAIN RELIEVER AND FEVER REDUCER, CHILDRENS IBUPROFEN, CONCENTRATED IBUPROFEN INFANTS, JUNIOR STRENGTH ADVIL, IBU, MEDIQUE IPRIN, MEDI-FIRST IBUPROFEN, MEDI-FIRST PLUS IBUPROFEN, DOVER ADDAPRIN, GREEN GUARD IBUPRO RELIEF, CHILDRENS ADVIL, CARE ONE IBUPROFEN CHILDRENS, CHILDRENS MOTRIN, CHILDRENS IBUPROFEN ORAL SUSPENSION DYE FREE, ULINE IBUPROFEN, GOOD NEIGHBOR PHARMACY IBUPROFEN, UP AND UP CHILDRENS IBUPROFEN, DYE FREE CHILDRENS IBUPROFEN, BASIC CARE IBUPROFEN, XPECT IBUPROFEN, IBUPROFEN INFANTS, IBUPROFEN MINIS, KOSHER MEDS, EQUATE IBUPROFEN, FOSTER AND THRIVE CHILDRENS IBUPROFEN IB, DYE-FREE PAIN RELIEF, IBUPROFEN MINI DYE FREE, DOLEX FLEX, IBUPAK, DYE FREE IBUPROFEN, ADVIL LIQUI-GELS, BETR PAIN RELIEF +107 more
- Generic name
- IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE
- Manufacturer name
- DOLGENCORP INC, American Sales Company, Strive Pharmaceuticals Inc., Rite Aid Corporation, Dolgencorp, Inc., HyVee Inc, Best Choice, Harris Teeter, Kroger Company, Cardinal Health 110, LLC. dba Leader, PuraCap Pharmaceutical LLC, NUVICARE LLC, Geritrex LLC, L. Perrigo Company, Spirit Pharmaceutical LLC, Meijer, Inc., TWIN MED LLC, Better Living Brands, LLC, Wal-Mart Stores, Inc., Haleon US Holdings LLC, SAM'S WEST INC, Dr. Reddy's Laboratories Limited, Unifirst First Aid Corporation, Chartwell RX, LLC, CVS Pharmacy, TIME CAP LABORATORIES,INC, Kenvue Brands LLC, Aurohealth LLC, AptaPharma Inc., Chain Drug Marketing Association Inc., Uline, Breeden Brothers, LLC, FSA STORE INC., Shield Pharmaceuticals Corp, Amerisource Bergen, Target Corporation, CVS, Amazon.com Services LLC, Advagen Pharma Ltd., WALGREEN COMPANY +181 more
- Product NDC
- 55910-518, 41520-495, 70692-175, 11822-3307, 55910-847, 42507-660, 63941-128, 72036-212, 30142-497, 70000-0263, 51013-319, 84324-039, 54162-941, 0113-7366, 68210-0026, 79481-0419, 55681-401, 21130-216, 49035-635, 0573-0179, 68196-601, 55111-682, 55111-683, 55111-684, 47682-600, 47682-614, 47682-608, 47682-609, 47682-602, 47682-610, 42507-461, 0573-0170, 0573-0174, 0573-0171, 0573-0290, 0573-0207, 0573-0232, 62135-400, 62135-401, 62135-402 +726 more
- Product type
- HUMAN OTC DRUG, HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAVENOUS
- Substance name
- IBUPROFEN
- RxCUI
- 310964, 310965, 197803, 204442, 310963, 731536, 197805, 197806, 197807, 206905, 206913, 206917, 900434, 900438, 206878, 544393, 731533, 854183, 854187, 2178273, 2178275, 153008, 854762, 197804, 201126, 792242, 1101919, 731531, 198405, 731535, 606990
- SPL ID
- 54eef6fc-7454-43e3-e063-6294a90a55d7, 205f36be-471e-40e2-9377-84b1ed6962df, ec00fff0-0234-4676-a238-200176391de7, 426ad787-5608-4a65-bb9e-69843dd3c9e7, 29a1e9b5-d8dd-c566-e063-6394a90a65c1, 1c29b26b-8184-4f01-b002-285c3cf5c54e, 1f314365-45d0-40c1-806b-7a3c6ea7d283, 57c16fe3-9675-7fd6-e063-6394a90ad3e7, b8c04a4a-027d-44ad-84f0-6fec957b9f64, 190f0279-7683-440a-aec8-7ee9445c1f9b, 127ceac7-923c-47f4-a768-47f7e46b2e97, 88500cb1-eb13-4bc3-9cb4-6c0b9557e57b, f6080edf-c278-4721-8335-4c299adf0c9e, cd06ffc5-4921-4b2d-88ea-939fa4daf59c, 2a8259ca-1448-91b8-e063-6394a90a7057, e515720d-be79-4de9-b2b8-73bcc4c80042, 5736a23e-dcda-fd8f-e063-6394a90a1d34, 3b217d19-5b93-40ef-a06d-471fb15b194c, ad449225-ed60-4c66-9fd6-34bef9a4b42e, 60e9724f-3733-45d1-989d-8ee434e91dc0, 1981f532-be83-7eb6-e063-6394a90aa28d, a7977972-4353-9ca0-d419-e37039010e7d, 3e5d4984-a2e6-a9fc-e063-6394a90a4396, 3e5d431e-d37b-8468-e063-6394a90a0c2a, b2295ddf-f7d7-4fdb-8864-aa9dfebb3f4f, 88972802-d04c-4fe3-8c56-3c3d1e3b4218, 459c7414-f956-35a9-e063-6294a90aa1d5, 85ed61ec-e444-4d29-9c5d-1ebc182fce10, a7ab73c2-f902-4645-877c-222486373633, 20b8a0bc-778a-7848-e063-6394a90ad512, 05caceca-42be-495e-8f59-1a913bfdb3f0, 21d440bd-8a6a-5109-e063-6394a90a0e8f, f2a13fd9-261e-4b50-9d92-cff6436af9ce, f9029942-7f22-4dac-9e80-2d3d995804e6, c7e59784-a338-4922-a806-98c7505957cd, 3e5d77e9-9142-41d7-e063-6294a90a365e, ddc06a6b-1e57-4d1b-83fe-28c4d68c4c8c, 37cb3dd7-010e-fc60-e063-6394a90ae846, 5a734646-aca1-d2d8-e063-6394a90a578e, 3e752137-0911-47c2-b434-48c16eec3fd2 +626 more
- SPL set ID
- 03138a6f-653a-f359-e063-6394a90ac5d6, 03cdff8a-8890-440d-82b5-54ce809f88cc, 24fb3741-65e0-898d-e063-6394a90af569, 389454b7-c17d-4413-b1ab-dee9a13f81cf, 5398f5b7-a9a6-4f7e-a06c-e524b9939562, 55f8def6-f7de-4b3e-a92a-5cd9e68a46a1, 55fd05c7-b902-4c82-ab9a-8054d880dfbd, 637210f0-6494-4656-8b2b-14d7476cb127, 6dc009c8-5b44-4d53-b053-eaed2223d975, 913a4bd0-0784-45b4-b05e-3e7c016bbb86, acc4cbc8-085d-42f3-ad93-113e0b55631c, b063d2dc-d579-46e7-8cfc-1596c803c7f9, ca9498ec-755d-4a09-9504-210dd48d6fed, cd06ffc5-4921-4b2d-88ea-939fa4daf59c, e172a8d8-779d-4ad9-b6b0-08a198a58034, eed4f13d-4bee-4ccc-a651-a6f86d6d1f7b, f03958f8-aeae-edf0-e053-2a95a90a3e9e, fab39a0a-882b-bf96-e053-6294a90a2932, 00b7fc71-8cf0-4c12-a479-146408f7f91b, 07d4c400-b182-92f7-7574-9e0e94c39cce, 16595d75-6e74-0839-e063-6394a90abc13, 24731405-219c-79b4-ecf0-7d5fbfda94ba, 2910b50b-c8de-382b-e054-00144ff88e88, 2923c4a3-f994-67a7-e054-00144ff8d46c, 2fd51545-1d1f-4b2e-a084-d28ba223e720, 3079d932-afb2-94fe-f4ba-a3d8b5198fce, 39f2664f-6c0a-4726-85d7-4227530d4a49, 6d047655-2b29-4f74-ac6e-93b02c25870c, 703869c9-7f12-4556-a2af-8e68942834f2, 82aad715-f652-471b-840c-5151c66e5ade, 884d51d8-4774-4dde-b854-32abfb4b712d, 9e1cdef7-921f-4163-869c-6c062e31c5bb, ad55d9b1-17b3-4a17-a4a3-d95ba2943959, bb995c57-a2cc-4bc7-9c7d-f885c425be64, c7e59784-a338-4922-a806-98c7505957cd, d7342a15-9d49-74ed-e053-2a95a90a22cc, e4314153-479d-4c0f-ba49-4d4efded304b, ec6b015d-e72e-89c4-e053-2a95a90af81c, fef89d3f-16e1-4a76-aabd-11d6eca4be86, 08d9477e-3033-4b74-8f81-934f39e37e55 +626 more
- Package NDC
- 55910-518-11, 55910-518-15, 55910-518-22, 55910-518-26, 41520-495-71, 41520-495-78, 70692-175-95, 11822-3307-2, 11822-3307-1, 55910-847-10, 55910-847-02, 42507-660-00, 42507-660-26, 42507-660-28, 63941-128-24, 72036-212-02, 72036-212-03, 72036-212-08, 30142-497-10, 70000-0263-1, 70000-0263-2, 70000-0263-3, 51013-319-54, 84324-039-01, 54162-941-90, 54162-941-00, 0113-7366-24, 0113-7366-62, 68210-0026-2, 68210-0026-1, 79481-0419-0, 55681-401-03, 21130-216-20, 49035-635-09, 0573-0179-20, 68196-601-60, 55111-682-09, 55111-682-01, 55111-682-05, 55111-683-30 +2,023 more
- Nui
- N0000000160, M0001335, N0000175722
- Pharm class moa
- Cyclooxygenase Inhibitors [MoA]
- Pharm class cs
- Anti-Inflammatory Agents, Non-Steroidal [CS]
- Pharm class epc
- Nonsteroidal Anti-inflammatory Drug [EPC]
- UNII
- WK2XYI10QM
- Drugcharacterization
- 2
- Medicinalproduct
- MELATONIN
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- MELATONIN
- Harmonized identifiers (openFDA)
- Brand name
- MELATONIN, MELATONIN PHENOLIC, MELATONIN CORD, MELATONIN 1527
- Generic name
- MELATONIN
- Manufacturer name
- BioActive Nutritional, Inc., Energique, Inc., Professional Complementary Health Formulas, Deseret Biologicals, Inc.
- Product NDC
- 43857-0511, 43857-0086, 44911-0247, 44911-0194, 63083-1527, 43742-0771
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- MELATONIN
- SPL ID
- adcac0e0-d21f-4124-b951-e6913591ac9f, e189499d-9da3-43fc-8a0b-9d5dd0923b11, adde04ad-3287-4fe9-b9e5-6385123b7da3, 3c4502c5-e02b-43e1-94e8-55f92983e63c, 149c1dc0-8f8d-4b51-9caa-c74ed9c86822, 43f1b593-3e12-4009-af39-7d4b35a291ea
- SPL set ID
- 8951e5e9-5d8f-4808-b247-208760fae656, cd82eb5d-a44a-4512-ad65-0fffae70d1d0, 895cb8a5-33ea-4764-86a6-1da513dcd2c1, 9a59554b-14c4-4c79-9db1-0a38b3c152f2, eb411c99-fe69-400d-b452-95d8d6d754b8, 4ea9b3dc-a6f7-48b0-b0a7-ac2951bc575d
- Package NDC
- 43857-0511-1, 43857-0086-1, 44911-0247-1, 44911-0194-1, 63083-1527-1, 43742-0771-1
- UNII
- JL5DK93RCL
- Drugcharacterization
- 2
- Medicinalproduct
- OMEPRAZOLE
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- OMEPRAZOLE
- Harmonized identifiers (openFDA)
- Application number
- NDA022032, ANDA079182, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, ANDA206582, ANDA075576, NDA209400, ANDA091352, ANDA216096, ANDA203481, ANDA207740, ANDA076515, ANDA076048, ANDA211732, ANDA204012, ANDA218829, ANDA091672, ANDA213201, ANDA078490, ANDA212977, ANDA203270
- Brand name
- GOOD NEIGHBOR PHARMACY OMEPRAZOLE, OMEPRAZOLE/SODIUM BICARBONATE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, FOSTER AND THRIVE OMEPRAZOLE, ACID REDUCER, GOOD NOW OMEPRAZOLE, GOOD SENSE OMEPRAZOLE, BASIC CARE OMEPRAZOLE, BERKLEY AND JENSEN OMEPRAZOLE, UP AND UP OMEPRAZOLE, EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER, DG HEALTH OMEPRAZOLE, TOPCARE OMEPRAZOLE, CAREONE OMEPRAZOLE, EQUALINE OMEPRAZOLE, LEADER OMEPRAZOLE, EQUATE OMEPRAZOLE, DG HEALTH OMPERAZOLE, OMEPRAZOLE DELAYED-RELEASE, SIGNATURE CARE OMEPRAZOLE, MEMBERS MARK OMEPRAZOLE, AMAZON BASIC CARE OMEPRAZOLE, RUGBY OMEPRAZOLE, TOPCARE OMEPRAZOLE DELAYED RELEASE, 24 HR OMEPRAZOLE, CARE ONE OMEPRAZOLE, EXCHANGE SELECT OMEPRAZOLE, GOOD SENSE OMEPRAZOLE DELAYED RELEASE
- Generic name
- OMEPRAZOLE, OMEPRAZOLE MAGNESIUM
- Manufacturer name
- Amerisource Bergen, Strides Pharma Science Limited, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., Strategic Sourcing Services LLC, STRATEGIC SOURCING SERVICES LLC, GERI-CARE PHARMACEUTICALS, CORP, Lannett Company, Inc., WALGREEN CO., Sandoz Inc, Cardinal Health, Chartwell RX, LLC, CVS Pharmacy, Inc., HARRIS TEETER, PLD Acquisitions LLC DBA Avma Pharma Solutions, RELIABLE 1 LABORATORIES LLC, DISCOUNT DRUG MART, Gobrands, Inc, L. Perrigo Company, WinCo Foods, LLC, Amazon.com Services LLC, Meijer Distribution Inc., Meijer Distribution Inc, BJWC, CVS Pharmacy, H E B, Quallent Pharmaceuticals Health LLC, Target Corporation, Fred's, Inc., Wal-Mart Stores Inc, THE KROGER COMPANY, HyVee Inc, Dolgencorp, LLC, Topco Associates LLC, Dolgencorp Inc, Zydus Lifesciences Limited, NORTHEAST PHARMA, P & L Development, LLC, CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, Retail Business Services, LLC +53 more
- Product NDC
- 46122-281, 64380-182, 64380-183, 63981-915, 57483-740, 70677-1275, 70677-1098, 57896-659, 62175-114, 62175-118, 62175-136, 0363-1008, 0781-2785, 0781-2790, 70000-0521, 62135-559, 62135-530, 69842-941, 72036-981, 63548-8040, 69618-054, 53943-016, 82501-0915, 0113-0915, 67091-464, 57483-840, 72288-047, 79481-0061, 41250-915, 68391-915, 59779-503, 37808-401, 59640-047, 82009-022, 11673-346, 55315-996, 49035-915, 30142-992, 42507-164, 55910-915 +156 more
- Product type
- HUMAN OTC DRUG, HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- OMEPRAZOLE, SODIUM BICARBONATE, OMEPRAZOLE MAGNESIUM
- RxCUI
- 402014, 753557, 753562, 198051, 199119, 200329, 2003656
- SPL ID
- b734d645-be14-4398-b7e2-9017c771fff1, 2ac68a93-2f3b-46aa-a874-c109ad1bfefe, 633c827b-bb87-4c7f-9865-633006a60e21, ce5c9fdc-0c50-4315-8f11-e00c9810abd0, 07de4a08-07e5-444b-8d1b-7f259b32936e, 252eeb77-6319-49df-9259-fcf2f917b2b5, df05ccee-e8d0-43b2-a266-86afc1ce741c, e786b865-dc62-4018-9cb1-7056b7ca2cde, f3c6b5e7-49d3-4c89-907f-782953c31b90, 24a57c2e-eda8-4c3f-9c81-a28a5b9a9229, a54de89f-8710-4fc7-97c3-8607e5974263, 2df74daf-da0f-36e2-e063-6294a90abc9d, 46879e67-0bb9-93a7-e063-6294a90af37d, 94a59c53-72bd-4d37-9ea9-c73f51ea1031, ca9797c6-5708-4d45-bd1a-c670077e1a0b, 4e880f49-93d0-436b-a072-c3286d358e45, ba632dd1-c85a-49c0-88a6-6d10ddbff1af, 0029ee94-3c34-42fb-982f-9baefdfe0b3b, e838a28b-a3ad-42dd-b755-d3bdd7534e2d, 1d135e1c-1e90-4e42-a2c7-2ef3b3fc6545, 5c220251-3504-4c65-a385-85920515c499, 3fc301fe-e89b-488b-8437-c48b59cec420, e00843ad-85f1-458c-9f2c-c1c4b41947a7, 77a11f0a-d2ce-40b7-8c19-011d6665d18b, 88bf3550-4633-47fe-88ec-e9ca94f7f752, 74157f10-5953-44de-abf5-b6793f13e70d, 2d9d60cd-6c79-4da7-9c48-ac1b73df9832, 9cb203e7-86d0-4757-9a32-afd2038898a3, 5d5df90d-3535-4337-99d8-e7e0309b433e, 17380ad5-9506-8e44-aa84-b6ce52ac7b9b, dc644613-1131-499d-9c16-7ee241a10c26, 5df31fd8-49c4-4a00-aadc-3f02860ab01f, 03d865a0-ac92-49d5-82e2-2276292add17, 759b705a-526e-47e2-97f9-a78ab21a2c5d, c1ec28a1-d0e5-4878-8295-eb06ff5e1fd6, 4900f1e8-5133-4ef9-a871-4d88507d56eb, e1557259-5889-4677-981e-ebd3970162c8, 72620a9f-63f1-421d-825a-ac73e891cd08, 691b64ae-e6ff-4a10-9973-886901529db0, 29498c01-1121-44bf-9a93-d5c5438bb83c +124 more
- SPL set ID
- 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, cf6d293e-d70d-443e-8292-d693e93aab55, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c9fdc-0c50-4315-8f11-e00c9810abd0, 51bcc19d-acfc-487b-870b-251c8953741f, 56380ccc-6fc2-4e1b-bd87-da24c9aa31cd, 8a77aea7-912e-43a3-bce3-f666b9b9c9bc, 92201fb1-4570-42db-8da3-3b8c0e291d32, b9561780-e358-b610-e053-2a95a90af020, e4562da8-9d94-4417-9f80-c1ffd4247259, 230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8, 4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e, 10f5502a-2e63-4f2a-a3ba-ddc5bd403051, 3349ee88-e53b-4586-8d28-20ecf8fcb1a5, c618964f-4b16-448e-851b-e6b2a816c660, e67bf2c6-0618-48e0-aa08-705501d86431, f6b13640-6c71-4c3d-8eb5-c36fca201aee, ff2c8446-9d8b-4300-b157-884b48e98bb7, 0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f, 11dfbf6c-59bf-4a30-b627-f49ccd31c0d0, 2782b98b-50e4-4a4e-8626-d34ebfd71bfb, 7535a309-1a67-4f50-911b-7cf570322931, 76b941f0-a02f-43e8-821e-09ccf675d944, 8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573, 925399c7-dcbc-4546-9111-2a98a11ba538, f74752a8-a686-4c7d-91ad-8c87c4596a7a, fb3b1c3b-d486-4fa6-9ebf-ee1812ed2512, 491e3710-9a15-4b07-ae22-923bd1152ecc, 501d80c0-68ee-4fd9-bc56-0b214dbf72b5, 665e9877-85ac-fdb6-54ac-1c47941ceab8, 7dc339da-e90b-452b-b25e-8d7f3aa8bc18, 7f00d0ed-4b7e-7011-e053-2a91aa0a2454, 9a0f2d8a-eaad-403b-90c3-0fd275abe4dc, f55cedc7-e0bc-4d30-af52-bfa881f6adde, fd22d4df-9679-4c2d-9bc4-3619288fb4cc, 326bf21c-fad4-473e-9e7f-797319d4353a, 4d98665d-38db-4c08-8406-cc0e45f7ab7c, 6d19783d-2856-4a86-9f5c-6cc26b4ca33e, 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2, 35ceccb5-dc3d-4ee1-bdac-35cb52c22f59 +124 more
- Package NDC
- 46122-281-04, 46122-281-74, 64380-183-01, 64380-183-02, 64380-182-01, 64380-182-02, 63981-915-55, 57483-740-01, 57483-740-42, 70677-1275-2, 70677-1275-1, 70677-1098-1, 57896-659-14, 57896-659-42, 62175-114-37, 62175-114-32, 62175-114-46, 62175-114-49, 62175-118-49, 62175-118-32, 62175-118-46, 62175-118-37, 62175-118-43, 62175-136-32, 62175-136-46, 62175-136-37, 62175-136-43, 62175-136-49, 0363-1008-05, 0363-1008-61, 0363-1008-62, 0781-2785-31, 0781-2785-01, 0781-2785-10, 0781-2790-10, 0781-2790-01, 0781-2790-92, 0781-2790-31, 70000-0521-1, 70000-0521-3 +534 more
- Nui
- N0000175525, N0000000147, N0000182140
- Pharm class epc
- Proton Pump Inhibitor [EPC]
- Pharm class moa
- Proton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]
- UNII
- KG60484QX9, 8MDF5V39QO, 426QFE7XLK
- Drugcharacterization
- 2
- Medicinalproduct
- OMEPRAZOLE
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- OMEPRAZOLE
- Harmonized identifiers (openFDA)
- Application number
- NDA022032, ANDA079182, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, ANDA206582, ANDA075576, NDA209400, ANDA091352, ANDA216096, ANDA203481, ANDA207740, ANDA076515, ANDA076048, ANDA211732, ANDA204012, ANDA218829, ANDA091672, ANDA213201, ANDA078490, ANDA212977, ANDA203270
- Brand name
- GOOD NEIGHBOR PHARMACY OMEPRAZOLE, OMEPRAZOLE/SODIUM BICARBONATE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, FOSTER AND THRIVE OMEPRAZOLE, ACID REDUCER, GOOD NOW OMEPRAZOLE, GOOD SENSE OMEPRAZOLE, BASIC CARE OMEPRAZOLE, BERKLEY AND JENSEN OMEPRAZOLE, UP AND UP OMEPRAZOLE, EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER, DG HEALTH OMEPRAZOLE, TOPCARE OMEPRAZOLE, CAREONE OMEPRAZOLE, EQUALINE OMEPRAZOLE, LEADER OMEPRAZOLE, EQUATE OMEPRAZOLE, DG HEALTH OMPERAZOLE, OMEPRAZOLE DELAYED-RELEASE, SIGNATURE CARE OMEPRAZOLE, MEMBERS MARK OMEPRAZOLE, AMAZON BASIC CARE OMEPRAZOLE, RUGBY OMEPRAZOLE, TOPCARE OMEPRAZOLE DELAYED RELEASE, 24 HR OMEPRAZOLE, CARE ONE OMEPRAZOLE, EXCHANGE SELECT OMEPRAZOLE, GOOD SENSE OMEPRAZOLE DELAYED RELEASE
- Generic name
- OMEPRAZOLE, OMEPRAZOLE MAGNESIUM
- Manufacturer name
- Amerisource Bergen, Strides Pharma Science Limited, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., Strategic Sourcing Services LLC, STRATEGIC SOURCING SERVICES LLC, GERI-CARE PHARMACEUTICALS, CORP, Lannett Company, Inc., WALGREEN CO., Sandoz Inc, Cardinal Health, Chartwell RX, LLC, CVS Pharmacy, Inc., HARRIS TEETER, PLD Acquisitions LLC DBA Avma Pharma Solutions, RELIABLE 1 LABORATORIES LLC, DISCOUNT DRUG MART, Gobrands, Inc, L. Perrigo Company, WinCo Foods, LLC, Amazon.com Services LLC, Meijer Distribution Inc., Meijer Distribution Inc, BJWC, CVS Pharmacy, H E B, Quallent Pharmaceuticals Health LLC, Target Corporation, Fred's, Inc., Wal-Mart Stores Inc, THE KROGER COMPANY, HyVee Inc, Dolgencorp, LLC, Topco Associates LLC, Dolgencorp Inc, Zydus Lifesciences Limited, NORTHEAST PHARMA, P & L Development, LLC, CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, Retail Business Services, LLC +53 more
- Product NDC
- 46122-281, 64380-182, 64380-183, 63981-915, 57483-740, 70677-1275, 70677-1098, 57896-659, 62175-114, 62175-118, 62175-136, 0363-1008, 0781-2785, 0781-2790, 70000-0521, 62135-559, 62135-530, 69842-941, 72036-981, 63548-8040, 69618-054, 53943-016, 82501-0915, 0113-0915, 67091-464, 57483-840, 72288-047, 79481-0061, 41250-915, 68391-915, 59779-503, 37808-401, 59640-047, 82009-022, 11673-346, 55315-996, 49035-915, 30142-992, 42507-164, 55910-915 +156 more
- Product type
- HUMAN OTC DRUG, HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- OMEPRAZOLE, SODIUM BICARBONATE, OMEPRAZOLE MAGNESIUM
- RxCUI
- 402014, 753557, 753562, 198051, 199119, 200329, 2003656
- SPL ID
- b734d645-be14-4398-b7e2-9017c771fff1, 2ac68a93-2f3b-46aa-a874-c109ad1bfefe, 633c827b-bb87-4c7f-9865-633006a60e21, ce5c9fdc-0c50-4315-8f11-e00c9810abd0, 07de4a08-07e5-444b-8d1b-7f259b32936e, 252eeb77-6319-49df-9259-fcf2f917b2b5, df05ccee-e8d0-43b2-a266-86afc1ce741c, e786b865-dc62-4018-9cb1-7056b7ca2cde, f3c6b5e7-49d3-4c89-907f-782953c31b90, 24a57c2e-eda8-4c3f-9c81-a28a5b9a9229, a54de89f-8710-4fc7-97c3-8607e5974263, 2df74daf-da0f-36e2-e063-6294a90abc9d, 46879e67-0bb9-93a7-e063-6294a90af37d, 94a59c53-72bd-4d37-9ea9-c73f51ea1031, ca9797c6-5708-4d45-bd1a-c670077e1a0b, 4e880f49-93d0-436b-a072-c3286d358e45, ba632dd1-c85a-49c0-88a6-6d10ddbff1af, 0029ee94-3c34-42fb-982f-9baefdfe0b3b, e838a28b-a3ad-42dd-b755-d3bdd7534e2d, 1d135e1c-1e90-4e42-a2c7-2ef3b3fc6545, 5c220251-3504-4c65-a385-85920515c499, 3fc301fe-e89b-488b-8437-c48b59cec420, e00843ad-85f1-458c-9f2c-c1c4b41947a7, 77a11f0a-d2ce-40b7-8c19-011d6665d18b, 88bf3550-4633-47fe-88ec-e9ca94f7f752, 74157f10-5953-44de-abf5-b6793f13e70d, 2d9d60cd-6c79-4da7-9c48-ac1b73df9832, 9cb203e7-86d0-4757-9a32-afd2038898a3, 5d5df90d-3535-4337-99d8-e7e0309b433e, 17380ad5-9506-8e44-aa84-b6ce52ac7b9b, dc644613-1131-499d-9c16-7ee241a10c26, 5df31fd8-49c4-4a00-aadc-3f02860ab01f, 03d865a0-ac92-49d5-82e2-2276292add17, 759b705a-526e-47e2-97f9-a78ab21a2c5d, c1ec28a1-d0e5-4878-8295-eb06ff5e1fd6, 4900f1e8-5133-4ef9-a871-4d88507d56eb, e1557259-5889-4677-981e-ebd3970162c8, 72620a9f-63f1-421d-825a-ac73e891cd08, 691b64ae-e6ff-4a10-9973-886901529db0, 29498c01-1121-44bf-9a93-d5c5438bb83c +124 more
- SPL set ID
- 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, cf6d293e-d70d-443e-8292-d693e93aab55, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c9fdc-0c50-4315-8f11-e00c9810abd0, 51bcc19d-acfc-487b-870b-251c8953741f, 56380ccc-6fc2-4e1b-bd87-da24c9aa31cd, 8a77aea7-912e-43a3-bce3-f666b9b9c9bc, 92201fb1-4570-42db-8da3-3b8c0e291d32, b9561780-e358-b610-e053-2a95a90af020, e4562da8-9d94-4417-9f80-c1ffd4247259, 230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8, 4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e, 10f5502a-2e63-4f2a-a3ba-ddc5bd403051, 3349ee88-e53b-4586-8d28-20ecf8fcb1a5, c618964f-4b16-448e-851b-e6b2a816c660, e67bf2c6-0618-48e0-aa08-705501d86431, f6b13640-6c71-4c3d-8eb5-c36fca201aee, ff2c8446-9d8b-4300-b157-884b48e98bb7, 0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f, 11dfbf6c-59bf-4a30-b627-f49ccd31c0d0, 2782b98b-50e4-4a4e-8626-d34ebfd71bfb, 7535a309-1a67-4f50-911b-7cf570322931, 76b941f0-a02f-43e8-821e-09ccf675d944, 8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573, 925399c7-dcbc-4546-9111-2a98a11ba538, f74752a8-a686-4c7d-91ad-8c87c4596a7a, fb3b1c3b-d486-4fa6-9ebf-ee1812ed2512, 491e3710-9a15-4b07-ae22-923bd1152ecc, 501d80c0-68ee-4fd9-bc56-0b214dbf72b5, 665e9877-85ac-fdb6-54ac-1c47941ceab8, 7dc339da-e90b-452b-b25e-8d7f3aa8bc18, 7f00d0ed-4b7e-7011-e053-2a91aa0a2454, 9a0f2d8a-eaad-403b-90c3-0fd275abe4dc, f55cedc7-e0bc-4d30-af52-bfa881f6adde, fd22d4df-9679-4c2d-9bc4-3619288fb4cc, 326bf21c-fad4-473e-9e7f-797319d4353a, 4d98665d-38db-4c08-8406-cc0e45f7ab7c, 6d19783d-2856-4a86-9f5c-6cc26b4ca33e, 2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2, 35ceccb5-dc3d-4ee1-bdac-35cb52c22f59 +124 more
- Package NDC
- 46122-281-04, 46122-281-74, 64380-183-01, 64380-183-02, 64380-182-01, 64380-182-02, 63981-915-55, 57483-740-01, 57483-740-42, 70677-1275-2, 70677-1275-1, 70677-1098-1, 57896-659-14, 57896-659-42, 62175-114-37, 62175-114-32, 62175-114-46, 62175-114-49, 62175-118-49, 62175-118-32, 62175-118-46, 62175-118-37, 62175-118-43, 62175-136-32, 62175-136-46, 62175-136-37, 62175-136-43, 62175-136-49, 0363-1008-05, 0363-1008-61, 0363-1008-62, 0781-2785-31, 0781-2785-01, 0781-2785-10, 0781-2790-10, 0781-2790-01, 0781-2790-92, 0781-2790-31, 70000-0521-1, 70000-0521-3 +534 more
- Nui
- N0000175525, N0000000147, N0000182140
- Pharm class epc
- Proton Pump Inhibitor [EPC]
- Pharm class moa
- Proton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]
- UNII
- KG60484QX9, 8MDF5V39QO, 426QFE7XLK
- Drugcharacterization
- 2
- Medicinalproduct
- TACROLIMUS
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- TACROLIMUS
- Harmonized identifiers (openFDA)
- Application number
- ANDA210393, ANDA211688, ANDA203740, NDA050777, ANDA206662, ANDA215012, ANDA206651, ANDA090509, NDA050708, NDA210115, NDA050709, ANDA090802, ANDA200744, ANDA212387, ANDA091195, ANDA213112, NDA206406, ANDA090596, ANDA090687, ANDA217108
- Brand name
- TACROLIMUS, PROGRAF, ENVARSUS XR
- Generic name
- TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES
- Manufacturer name
- Glenmark Pharmaceuticals Inc., USA, Accord Healthcare Inc., Ascend Laboratories, LLC, Padagis Israel Pharmaceuticals Ltd, NORTHSTAR RX LLC, Amneal Pharmaceuticals NY LLC, BPI Labs LLC, Quallent Pharmaceuticals Health LLC, Astellas Pharma US, Inc., Jubilant Cadista Pharmaceuticals Inc., E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, Encube Ethicals, Inc., Dr. Reddy's Laboratories Limited, Stellon Biotech Inc., Veloxis Pharmaceuticals, Inc, Mylan Pharmaceuticals Inc., Strides Pharma Science Limited, Chengdu Suncadia Medicine Co., Ltd., Nexus Pharmaceuticals, LLC, Panacea Biotec Limited, CONCORD BIOTECH LIMITED, Ajenat Pharmaceuticals LLC
- Product NDC
- 68462-534, 68462-881, 16729-421, 16729-422, 67877-278, 67877-279, 67877-280, 45802-390, 45802-700, 16714-098, 16714-099, 16714-100, 69238-2780, 69238-2781, 69238-2782, 54288-133, 54288-135, 54288-134, 82009-054, 82009-164, 82009-165, 0469-0607, 0469-0617, 0469-0657, 0469-3016, 0469-1230, 0469-1330, 59746-798, 59746-799, 59746-800, 0168-0416, 0168-0417, 21922-011, 68462-685, 68462-686, 68462-687, 55111-525, 55111-526, 55111-527, 16729-041 +27 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL, ORAL, INTRAVENOUS
- Substance name
- TACROLIMUS
- RxCUI
- 313189, 314266, 198377, 198378, 313190, 1431971, 1431980, 1431985, 108513, 108514, 108515, 198379, 261134, 2052605, 2052609, 2052703, 2052704, 2665161, 2665162, 2665163, 1664434, 1664440, 1664456, 1664458, 1664461, 1664463
- SPL ID
- 15dcd504-ee3e-4f0f-a765-55e31511641e, 23a804e6-2854-6b9b-e063-6394a90af669, 46ed8f56-e67b-4faa-9ad3-1c07ae46e8ac, ca08f41f-bc87-45bb-91b8-1d89adfba78f, 0e68684e-7947-40a2-b17c-7919e94163a5, 05c70395-3037-4e8a-be20-dd9f4aebbe06, f2e9bcc1-fc42-4fab-a6b2-aceaa77fb2b9, 3e44dd25-4ad2-6ddc-f77b-7a66fc7fb89a, e9157663-1515-4ba3-83b5-1622cf6f0f99, e39f4aa6-bc0f-413d-b855-3bf869c2e2ee, a63cc4f4-5aba-4e02-915a-5535f2b625aa, 9197a805-bb44-44b8-9ae7-d39a01acb1a7, 13e3f94c-d4c5-4b5b-a51a-0e87eadc5718, 706bafff-d629-291c-5ce5-83d74a638860, 3622f4f5-48bd-9035-e063-6294a90afac2, 53396094-b61b-4383-a680-82974cc9c159, 163c129d-f4e2-484d-af96-c265c9a5e38c, 7d8a5bab-a744-4aa7-b28f-d0c2c5a53628, d4a7fb82-5ff6-4ffc-bec5-ff0d50347a9b, 102bdf7c-9d79-0124-e063-6394a90aced9, 44fc0987-ff9d-3099-e063-6394a90a7a55, 5ddea519-e472-1380-e063-6394a90a5cd3, 76ffdfc1-7f00-49da-9578-5352593b4830, 6b08720e-dc88-4731-8863-af564a293b5a
- SPL set ID
- c2d2e3a1-f346-4245-b445-6dd44e371180, 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15, 55467f4b-8437-43a3-b6d9-1bc2a13b4c11, 6b601eaf-4f3a-4a8b-8cd8-1000defa9822, 875f4962-557e-4e12-ad7b-cb5fb6f2a65f, 4eb1b6bd-beec-4dd5-9a48-c93a9fe918b3, 3e8bc65e-8048-4073-8e45-570330603000, 23b7b4d7-1431-e9f2-43ba-eabd169dc2dd, 7f667de1-9dfa-4bd6-8ba0-15ee2d78873b, 651bd506-96b0-43e5-a4dd-db03bf9154c9, 1bf44a84-14fd-4f80-ad8a-99b1431d631f, 43b38551-6c5e-48a4-a453-9286f1c16b34, 4b310c6b-e035-4e44-9573-4001d58b2ad5, 61dee012-43af-0e9a-3843-9b9b91e022c4, bd447ffa-9196-4c3c-accf-5adf29b84665, 6b89e8a4-9f11-42e3-8e79-fe617e7c461f, de2315b0-6344-43ac-9aea-3e3b68d828e7, 45af3eda-caaa-4478-9372-95aa65adc9b3, ed7d1495-3585-409d-94f1-b3d2469d222c, 08cf2861-2483-405d-a872-a88a5c235f9a, 9d502961-e9c0-4611-92bf-ce742a7b962c, bd9fea26-0236-d437-c7df-4b7636210875, 823b11cb-d873-4017-a861-d22d2c5a8a49, ca08d4aa-3de2-4a9d-9554-6288e5d36f29
- Package NDC
- 68462-534-35, 68462-534-65, 68462-534-94, 68462-881-35, 68462-881-65, 68462-881-94, 16729-422-10, 16729-422-12, 16729-422-01, 16729-421-10, 16729-421-12, 16729-421-01, 67877-278-33, 67877-278-01, 67877-279-33, 67877-279-01, 67877-280-33, 67877-280-01, 45802-390-00, 45802-390-01, 45802-390-02, 45802-700-00, 45802-700-01, 45802-700-02, 16714-098-01, 16714-099-01, 16714-100-01, 69238-2780-3, 69238-2781-3, 69238-2782-3, 54288-135-01, 54288-134-01, 54288-133-01, 82009-164-01, 82009-054-01, 82009-165-01, 0469-0607-73, 0469-0617-73, 0469-0617-11, 0469-0657-73 +77 more
- UNII
- WM0HAQ4WNM
- Drugcharacterization
- 2
- Medicinalproduct
- TOPIRAMATE
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- TOPIRAMATE
- Harmonized identifiers (openFDA)
- Application number
- ANDA215414, ANDA078235, ANDA217694, ANDA208949, ANDA079162, ANDA217231, ANDA216683, ANDA215449, ANDA205976, NDA205122, ANDA078877, ANDA207382, ANDA218482, ANDA215638, NDA214679, ANDA077627, ANDA078462, ANDA215561, ANDA090278, ANDA217795, ANDA217869, ANDA215663, ANDA206210, ANDA210278, ANDA090162, ANDA076343, ANDA217443
- Brand name
- TOPIRAMATE, EPRONTIA, QUDEXY XR
- Generic name
- TOPIRAMATE
- Manufacturer name
- Camber Pharmaceuticals, Inc., Zydus Lifesciences Limited, Quallent Pharmaceuticals Health LLC, Upsher-Smith Laboratories, LLC, XLCare Pharmaceuticals, Inc., Cipla USA Inc., Dr. Reddys Laboratories Inc., Advagen Pharma Ltd, Zydus Pharmaceuticals USA Inc., Aurobindo Pharma Limited, Par Health USA, LLC, Ascend Laboratories, LLC, Vitruvias Therapeutics, Inc., Azurity Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc., USA, Lupin Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., EXELAN PHARMACEUTICALS INC., Ajanta Pharma USA Inc., Teva Pharmaceuticals, Inc., Unichem Pharmaceuticals (USA), Inc.
- Product NDC
- 31722-181, 31722-182, 31722-183, 31722-184, 65841-647, 65841-648, 65841-649, 65841-650, 82009-135, 82009-136, 82009-137, 24979-210, 24979-211, 72865-313, 72865-314, 72865-315, 72865-316, 70771-1656, 70771-1657, 70771-1658, 70771-1659, 70771-1660, 69097-816, 69097-817, 69097-818, 69097-819, 43598-939, 43598-940, 43598-941, 43598-942, 72888-228, 72888-229, 72888-230, 68382-138, 68382-139, 68382-140, 68382-141, 59651-452, 59651-453, 10370-365 +92 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- TOPIRAMATE
- RxCUI
- 151226, 199888, 199889, 199890, 205315, 205316, 1494769, 1812419, 1812421, 1812425, 1812427, 1436239, 1437278, 1437283, 1437288, 252413, 2586427, 2586433, 1494766, 1494771, 1494775, 1494778, 1494781
- SPL ID
- 62911647-4208-47b3-a9af-67f026411019, 85c62092-3b8c-43af-a980-e2d959e0c341, b67db755-e8c2-45bd-8954-19dbdf1a77c5, e82bef13-353e-4567-8881-21b797200722, 297988b4-69fb-4691-92e0-ee5da80b0125, 432dc54b-f28b-48c9-b417-2fbae070f41b, 1b47473e-6644-4026-90e5-b169fce62b60, 641acdcc-9618-84e0-a09a-cbf956ffbe61, 4e8dd02d-2263-78d0-e063-6294a90a5f0b, 48ba6ac8-7f36-4a5c-8055-295af6083862, f12f3b94-ddf4-4fe0-ba06-01e4ffad1b71, 3ea04de6-6c56-44ab-ba90-def5e0468ba5, 1be5841a-e872-475c-bfe9-859be4ba4001, c45924d5-c45b-4f31-afa5-0cbc090d2816, 709dd70b-24e1-435f-8373-02e6dd538b2c, 8dde15e5-8f0f-43bd-847f-08f5c015e4a1, 69df5f84-1db1-4eb2-ae32-462137a4d812, 0a7f1a1b-961e-4458-8312-7920a78e4dbe, 3feb6452-372c-4c60-8e91-220be75f90b1, c6569dc4-2be9-48f4-8e03-6da27ac996b0, 67afee59-3d84-418f-832c-d00abd43fe5b, bb736981-167f-4de6-a285-0e840ae37fc7, 68180c67-ab30-49d0-aece-5a8d476097e2, 2535bcc8-fac7-4b15-8c6f-fd6675655fd3, 5cfd7234-5efc-4cb8-b69c-7e68b9f1a94f, 26ca9b31-f93f-4a92-8d13-651ade1e1c77, b8c52970-05b0-43ea-9122-566998bf4524, 941c8d76-48bb-4f96-82d4-b39ffaa9df49, e698a828-b2a3-4c5e-8597-27ed8127d1e4, 9c981813-533d-40b5-b9ea-5648dd7c7da0, e4d3b13a-e354-421d-917a-613ad0a3ab35, 6a92525c-bf1f-4a48-90a7-62e9baaa553d, 2351e0f7-3f55-4580-b424-0c76c4d9670a, 4a2276a1-54f6-4de6-8710-c2c088a23e76, 961973db-b7ab-40fa-ad75-4163738def9b, 532f72d6-a509-0681-e063-6294a90ad4c1, 71f493d9-3aaa-4b13-8057-012e96e11dbc, c4f0c0d0-430f-4c9d-96f0-8c90f6af31e8
- SPL set ID
- cefbc5f4-ef5f-4732-ab96-a69a183f0b6b, 57016639-89fe-43ad-89c4-5e7a756dddec, 9dae6824-6913-42de-b98a-cdcb0d3b4a46, e0d88f34-865c-441b-80e2-e814c9a7d670, 546103e1-ea6e-466b-b0de-b1ff8c494512, 57b5d67b-b29b-4c18-a53d-51d5374f3be3, 4087eb3c-96e9-4d0a-b80b-663e1c86d256, f07d81bc-5090-fbc5-2945-557cf002849c, 48169bbc-4fb2-4bc4-9bdd-de71bf7722df, 67dcdd6e-48bc-418e-a887-805929d83ce0, d1588c37-9da9-4ccb-b78a-64234938a115, 11e0924b-fbee-4ec4-b1e4-22d7683b21ee, 691d276c-9cc1-4d39-828f-0f44d7ef6328, 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b, 9a943af0-1c6d-43c2-830a-f303baa16124, cb966bcb-3af7-4dbe-b540-58d473b891e5, e4886adf-199d-4b19-a4ef-75f8f94cb54e, a9d7c5ef-daf9-4f97-8673-7f4a2007f408, e2a4df59-fead-4a01-9021-9eda02c48010, 35312f49-decf-428d-bf5f-4215b762ed3c, 32b48ea0-a215-43b8-83b4-a5435a686d68, a5ca2fce-bd2d-40db-b963-e3ec27c8bf23, e310afcd-1260-434e-a994-34549c789d99, f72774dd-c7eb-41f9-9837-02baf77cc523, 46f54677-3a22-4c38-9b92-923020164e15, 9ac09563-5967-498c-93ae-675a7f4efc48, 2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef, 7bc4ec7a-9b83-4842-9057-e1a804b2596d, 035bf713-1642-4215-83ec-0ed07c29f92c, 690baf58-1ec9-463e-99b7-d601362ea56b, 872927eb-0b61-44bb-9892-3c700b6f2181, b94629e3-ae2e-473e-b2f5-06e32ee19aa9, 4f20155f-05b9-40ec-af34-3b58aa8d60d4, 54bfabce-1f8a-40ee-8b55-efce8fe6fbf1, 6ee00e82-799d-445e-b658-a9712c49a28e, 3c909a53-ae66-4b28-a741-b60bb25a69cf, ca4ec248-285d-4066-8f89-5ed0c538c4c9, dbc52b16-b93d-4d83-942b-485c502db1fa
- Package NDC
- 31722-181-60, 31722-181-05, 31722-182-60, 31722-182-05, 31722-183-60, 31722-183-05, 31722-184-60, 31722-184-05, 65841-647-14, 65841-647-16, 65841-647-01, 65841-647-05, 65841-648-14, 65841-648-16, 65841-648-01, 65841-648-05, 65841-649-14, 65841-649-16, 65841-649-01, 65841-649-05, 65841-650-14, 65841-650-16, 65841-650-01, 65841-650-05, 82009-135-05, 82009-136-05, 82009-137-05, 24979-210-04, 24979-211-04, 72865-313-60, 72865-313-10, 72865-314-60, 72865-314-10, 72865-315-60, 72865-315-10, 72865-316-60, 72865-316-10, 70771-1656-9, 70771-1656-3, 70771-1657-3 +343 more
- Nui
- N0000008486, N0000185506, N0000182140
- Pharm class pe
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Pharm class moa
- Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]
- UNII
- 0H73WJJ391
- Drugcharacterization
- 2
- Medicinalproduct
- TYLENOL (ACETAMINOPHEN)
- Drugseparatedosagenumb
- 1
- Activesubstance
- Activesubstancename
- TYLENOL (ACETAMINOPHEN)