Death
Drugs: CAPIVASERTIB, ACETAMINOPHEN, BENADRYL +5
- Safetyreportversion
- 1
- Safetyreportid
- 27325194
- Primarysourcecountry
- US
- Occurcountry
- US
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 2
- Serious
- 1
- Seriousnessdeath
- 1
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 2
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- US-AstraZeneca-CH-01210753A
- Primarysource
- Reportercountry
- US
- Qualification
- 5
- Sender
- Sendertype
- 6
- Senderorganization
- ALEXION PHARMACEUTICALS
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 72
- Patientonsetageunit
- 801
- Patientagegroup
- 6
- Patientweight
- 49
- Patientsex
- 2
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Death
- Reactionoutcome
- 5
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- CAPIVASERTIB
- Drugauthorizationnumb
- 218197
- Drugstructuredosagenumb
- 320
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 320 MILLIGRAM, BID
- Drugadministrationroute
- 061
- Drugindication
- Breast cancer female
- Drugstartdateformat
- 102
- Drugstartdate
- 20250506
- Actiondrug
- 1
- Drugrecurreadministration
- 3
- Activesubstance
- Activesubstancename
- CAPIVASERTIB
- Drugcharacterization
- 2
- Medicinalproduct
- ACETAMINOPHEN
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Activesubstance
- Activesubstancename
- ACETAMINOPHEN
- Harmonized identifiers (openFDA)
- Application number
- M013, ANDA211544, ANDA075077, part343, ANDA215486, NDA019872, M013.50, ANDA078569, M012, ANDA216617, ANDA207229, ANDA213255, ANDA219215, ANDA219096, ANDA204052, ANDA214331, NDA204957, NDA018337, ANDA070607, M, ANDA215403, ANDA202605, NDA204767, ANDA216592, ANDA076200, ANDA070608, NDA206968, ANDA210969
- Brand name
- AMAZON BASIC CARE ACETAMINOPHEN, PAIN RELIEF, MAXIMUM STRENGTH NON-ASPIRIN 100, MAXIMUM STRENGTH NON-ASPIRIN 250, TOPCARE PAIN RELIEF, ACETAMINOPHEN, PEDIACARE CHILDRENS ACETAMINOPHEN GRAPE, PAIN RELIEVER EXTRA STRENGTH, 8 HOUR ARTHRITIS PAIN, PAIN RELIEVER, CHILDRENS PAIN AND FEVER, TOPCARE CHILDRENS PAIN AND FEVER, TOPCARE 8 HR ARTHRITIS PAIN RELIEF, APAP, FOSTER AND THRIVE PAIN RELIEVER, CHILDRENS TYLENOL, GENEXA ACETAMINOPHEN EXTRA STRENGTH, ARTHRITIS PAIN RELIEVER, ARTHRITIS PAIN RELIEF, TYLENOL EXTRA STRENGTH, DR SIMI PAIN RELIEF 100, EXTRA STRENGTH ACETAMINOPHEN, EXTRA STRENGTH PAIN RELIEF, HEB, ACETAMINOPHEN EXTRA STRENGTH, CAREALL ACETAMINOPHEN, PAIN AND FEVER, PAIN RELIEF EXTRA STRENGTH, LEADER INFANTS PAIN AND FEVER, CHILDRENS ACETAMINOPHEN, TYLENOL 8 HR MUSCLE ACHES AND PAIN, CHILDRENS CHEWABLE ACETAMINOPHEN, PAIN RELIEF CHILDRENS, TYLENOL 8 HR ARTHRITIS PAIN, TYLENOL FOR CHILDREN PLUS ADULTS, INFANTS PAIN AND FEVER, UP AND UP ACETAMINOPHEN INFANTS, TYLENOL REGULAR STRENGTH, CHILDRENS PAIN RELIEF, DG HEALTH CHILDRENS PAIN AND FEVER +257 more
- Generic name
- ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER
- Manufacturer name
- Amazon.com Services LLC, Meijer, Inc., JHK Inc dba American Safety & First Aid, Sixarp, LLC, PAI Holdings, LLC dba PAI Pharma, HYVEE INC, RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH, L.N.K. International, Inc., AMERISOURCE BERGEN, WALMART INC. (see also Equate), Walgreen Company, Kroger Company, AptaPharma Inc., Topco Associates LLC, Granules USA, Inc, Advance Pharmaceutical Inc., Strategic Sourcing Services LLC, Kenvue Brands LLC, Genexa Inc., WALGREENS, LIDL US LLC, PUBLIX SUPERMARKETS, INC, KROGER COMPANY, Farmacias De Similares TX LLC, Meijer Distribution Inc, Pinnacle RX LLC, VALU MERCHANDISERS COMPANY, HEB, Magno-Humphries, Inc., Hi-Tech Nutraceuticals, LLC, CVS PHARMACY, New World Imports, Inc, Chain Drug Marketing Association, Cardinal Health 110, LLC. dba Leader, Aurohealth LLC, DISCOUNT DRUG MART, United Natural Foods, Inc. dba UNFI, American Health Packaging, P & L Development, LLC, GERI-CARE PHARMACEUTICAL CORP +226 more
- Product NDC
- 72288-405, 79481-0302, 73598-1122, 73598-1124, 59368-210, 0121-2094, 42507-404, 52412-906, 50844-519, 46122-629, 79903-172, 0363-1502, 30142-561, 76281-526, 36800-202, 69848-008, 36800-455, 17714-013, 70677-1138, 50580-579, 69676-0059, 0363-9781, 71141-176, 41415-177, 36800-779, 41226-699, 50580-490, 85786-102, 41250-959, 87438-0001, 63941-303, 37808-120, 54257-473, 69732-001, 69842-750, 51824-061, 0121-0941, 0121-1882, 0121-2823, 41250-590 +824 more
- Product type
- HUMAN OTC DRUG, HUMAN PRESCRIPTION DRUG
- Route
- ORAL, INTRAVENOUS, RECTAL
- Substance name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, DIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN
- RxCUI
- 313782, 198440, 307675, 307668, 1148399, 828555, 209459, 313820, 1243440, 307696, 209387, 198439, 307684, 1094549, 200977, 2683419, 2178755, 2178758, 1038779, 483017, 1043400, 2480095, 1100005, 2639351, 828557, 2715604, 198434, 209353, 477282, 1092189, 1358835, 665056, 198444, 198436, 1293942, 351580, 2374360, 2374361, 198437, 209361 +12 more
- SPL ID
- 5852c0f6-94f5-4555-8ca8-4c917fe05e4a, 047c3a4a-e08c-428e-9943-a7da4f2c3f9a, 993e1111-cac5-47d8-8c36-d4c74b95589c, 3d331504-788d-178e-e063-6294a90afeb1, b5e3c4bc-f8bd-4206-9619-00e073429c50, 440c1683-4b05-05f7-e063-6294a90a43b7, 2a812e53-97e7-9d66-e063-6394a90a72a2, 9f5e3344-4f7b-4096-a4f0-929e140c175c, 090568cf-d90d-2f8a-e063-6394a90a0136, 4cfa7932-bb16-4e51-8d30-995a7f3e20f3, 8446910d-7b7d-42d7-bdfd-8f2e7003c2fb, 09822782-9e5e-4ae3-b9ed-9b70ec05be0c, 5b15b381-438f-403f-8db3-ac8576244ea0, f5d35fd8-953d-48b6-a7a2-a79a9c3408db, 468e7582-908f-6ec4-e063-6394a90a1653, 6be40153-a08e-4a37-8416-75167ab0efa6, 60f41580-e099-faad-e053-2a91aa0a9076, ca93ae6e-997b-49c9-83c5-df0a8560ed55, 22d91a96-0b05-5f31-e063-6394a90aae0b, 51590662-8dac-1b90-e063-6294a90a49a2, 13b1dc8a-f101-bf67-e063-6294a90a2a95, 458b364a-a3ef-24ac-e063-6394a90ad1b8, 4652f331-53d5-7d40-e063-6294a90a4b3c, 2e7e553e-919a-4189-81bc-433bf33d4838, 34c32d65-9d1c-45ff-e063-6394a90a3b29, 4eda2e16-ed91-59d6-e063-6394a90abf72, 3c42e48d-cdb3-eb74-e063-6394a90a2940, d5259585-e312-4320-8c87-d2dd5a256d2b, 513cf101-7e8d-01e0-e063-6394a90a0b0b, 45b2da7e-84d3-5b1d-e063-6394a90a0cf8, f924d0ab-cfa6-7dbe-e053-6394a90abc40, 08bf6b23-2a85-3732-e063-6294a90a2305, 55f92c95-a399-6cf1-e063-6394a90a07af, f96cefa0-5a08-4358-b900-2428afef4ffb, 46900e60-e2c0-19df-e063-6394a90a8ef6, bbd6f65a-a6ec-4c17-935c-ed743c45e2c8, 23f6dc85-7928-46a8-b7eb-31669dd83b10, 1ac6e721-4d0a-0396-e063-6294a90a7fe9, 9e89c59e-c284-40a4-b75b-d568c595ea06, d4e98f8e-f24c-4bdd-b750-fa4f877fb621 +782 more
- SPL set ID
- 113d92bf-f6c9-cc3d-e063-6294a90af033, 1319bab8-8f17-44fb-9d91-099b0ba38a8d, 1d3e9948-883e-4668-9bb8-d699a283b51a, 2e20be17-2b6c-1a07-e063-6394a90acdd3, 355a094c-bed9-4959-8cf0-619f0e246105, 422796ed-7558-f7e8-e063-6294a90ad1c7, 596372c7-eca3-4527-8e22-ab0751e2526b, 72babe91-2586-4f05-ae90-6debfd23aa5d, 7888eff3-3030-4aa0-89e3-9795aa214659, 7d86a03f-74f4-4b24-b6a6-8747acfe905e, 8255900a-2d58-4261-8df7-f28319883570, 8fb19444-f0e0-4d26-81e8-6a4b835056d8, 9064943f-836f-4853-b6f2-2c4879941eeb, 911492d5-e065-4b8f-b2dc-cb6a6678d0ae, a51395ea-e038-dc9c-e053-2a95a90a287d, a82f8818-1c22-46d0-b05f-698d2395ac48, aba26f0a-94e4-4919-a3b0-033e3a9598ef, b8ee568c-80cf-4e35-865e-35516bdab0fd, ce0a1fbc-7345-462b-b0da-c7149bdc288c, d6f968ca-719f-5a68-e053-2995a90a4afa, e71f632f-37dd-49c0-e053-2a95a90a67d7, ec543339-20ab-2cba-e053-2995a90ac740, 08f57305-0c4b-96b1-e063-6394a90a77df, 0d427360-ff9d-4e98-b218-6eb6c015dc6a, 0fec22a3-aad0-8c28-e063-6394a90adc18, 201b860d-dc3c-4380-affa-e757bf2103cf, 3c42e48d-cdb2-eb74-e063-6394a90a2940, 44d50d79-6e47-429f-8cbe-6fcac4667732, 513cf0e1-6874-9402-e063-6294a90aedc6, 5a80cb17-7731-4457-acd3-64cf4accf862, 96b1808f-defa-28cb-e053-2995a90a563b, 9d22bedb-9fb3-8421-e053-2a95a90acf4a, a36be487-7a36-550f-e053-2a95a90a95c1, afacdc0b-fb65-464e-91b8-e82ba7ecde44, c4f82ed8-b82c-47bb-9ab9-108a13d29cf7, caf5daea-409e-5dd2-e053-2995a90acb12, cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf, cfaf9495-e654-4dfc-ba23-d2358c3720c4, cfbb8553-f3ac-437d-8f63-caa93f257a77, d4e98f8e-f24c-4bdd-b750-fa4f877fb621 +782 more
- Package NDC
- 72288-405-10, 79481-0302-1, 73598-1122-1, 73598-1124-1, 59368-210-01, 59368-210-02, 0121-2094-11, 0121-2094-00, 42507-404-09, 52412-906-01, 50844-519-12, 50844-519-20, 50844-519-21, 50844-519-15, 50844-519-02, 46122-629-71, 46122-629-78, 46122-629-81, 46122-629-62, 79903-172-04, 0363-1502-78, 30142-561-71, 30142-561-78, 30142-561-85, 30142-561-90, 30142-561-82, 30142-561-76, 30142-561-62, 76281-526-24, 76281-526-23, 36800-202-26, 36800-202-28, 36800-202-34, 36800-202-00, 69848-008-10, 36800-455-78, 36800-455-62, 36800-455-71, 36800-455-79, 36800-455-83 +1,721 more
- UNII
- 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, TC2D6JAD40, WK2XYI10QM
- 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]
- Drugcharacterization
- 2
- Medicinalproduct
- BENADRYL
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Activesubstance
- Activesubstancename
- DIPHENHYDRAMINE HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- M012
- Brand name
- BENADRYL
- Generic name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Manufacturer name
- Lil' Drug Store Products, Inc., Kenvue Brands LLC
- Product NDC
- 66715-6406, 66715-9706, 66715-6506, 50580-370, 50580-226
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- DIPHENHYDRAMINE HYDROCHLORIDE
- RxCUI
- 1049630, 1049632
- SPL ID
- 2783d396-2842-91e9-e063-6294a90a88fe, 21716a1f-3636-bdde-e063-6394a90aab01, 57a6b529-75db-f06e-e063-6294a90a7dd3
- SPL set ID
- de2a64ce-c169-4162-b79e-d3809bea2147, 2884d2dc-2d4a-4ca6-ab73-688a80b428eb, 702f9786-7ce9-43e4-921d-e1db09612127
- Package NDC
- 66715-9706-1, 66715-9706-2, 66715-9706-3, 66715-6406-2, 66715-6406-7, 66715-6406-8, 66715-6506-2, 50580-370-01, 50580-226-50, 50580-226-51, 50580-226-53, 50580-226-54, 50580-226-62, 50580-226-52, 50580-226-56, 50580-226-20, 50580-226-70, 50580-226-12, 50580-226-33
- UNII
- TC2D6JAD40
- Drugcharacterization
- 2
- Medicinalproduct
- CLARITIN
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Activesubstance
- Activesubstancename
- LORATADINE
- Harmonized identifiers (openFDA)
- Application number
- NDA020704, NDA020641, ANDA075209, NDA019658, ANDA210033, NDA021891, NDA021993
- Brand name
- CLARITIN REDITABS, CLARITIN ALLERGY, CLARITIN
- Generic name
- LORATADINE, LORATADINE TABLET
- Manufacturer name
- Bayer Healthcare LLC., Bayer HealthCare LLC., Lil' Drug Store Products, Inc., Bayer HealthCare LLC
- Product NDC
- 11523-4329, 11523-7157, 11523-0101, 11523-0007, 66715-9742, 11523-6655, 11523-0800, 11523-1527, 11523-7237, 11523-7160, 11523-4359, 11523-0104, 11523-4328, 11523-4331, 11523-7202, 11523-4330
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- LORATADINE
- RxCUI
- 311373, 744830, 692783, 755476, 206805, 311372, 665078, 668469, 672558, 904026
- SPL ID
- 4536fe84-5b46-ca4c-e063-6394a90ad03a, 4526da60-c33b-fb4a-e063-6294a90a8692, 4526b265-4250-3e71-e063-6294a90a21a8, 2a92670f-80b4-abdb-e063-6294a90a6342, 4523713e-42b4-1ee9-e063-6394a90abb7d, 4526e2eb-ee8d-3ac4-e063-6394a90a133f, 4536cd82-d67c-56be-e063-6294a90a7775, 4526d753-7999-0ec3-e063-6294a90a270f, 453703bf-d4b7-d090-e063-6394a90a7ebf, 45371bc6-b83d-a96d-e063-6294a90a7c40, 45370735-3f9c-a7f8-e063-6294a90aa0c6
- SPL set ID
- b681ea25-d00b-4c8a-8054-cc6f983ce337, 19afd658-8c67-af44-e063-6394a90abada, acf2d393-53d7-062f-e053-2995a90a0d60, f0e77162-c601-1a0f-e053-2a95a90ab714, ac32d6f9-f553-4d5c-ad36-575af5ea56de, dc65f7ec-bb83-7b29-e053-2995a90a99de, 660ac9df-f1b1-4c89-94dd-9fae0a013f3c, f3b9c643-a605-7702-e053-2995a90a6130, 37732ca2-b454-4215-91a2-c62e0f7a56af, 7dc04b48-f053-4e4b-a493-9e8286d2a791, 20938e05-bc3e-51aa-e054-00144ff88e88
- Package NDC
- 11523-7157-2, 11523-7157-3, 11523-7157-4, 11523-7157-7, 11523-7157-8, 11523-7157-9, 11523-4329-1, 11523-4329-2, 11523-0101-1, 11523-0101-2, 11523-0101-3, 11523-0007-1, 11523-0007-2, 11523-0007-3, 11523-0007-7, 11523-0007-4, 11523-0007-5, 11523-0007-8, 11523-0007-9, 11523-0007-6, 66715-9742-1, 66715-9742-2, 11523-6655-1, 11523-6655-2, 11523-6655-3, 11523-6655-4, 11523-6655-6, 11523-6655-7, 11523-6655-9, 11523-6655-8, 11523-6655-5, 11523-0800-1, 11523-0800-2, 11523-7237-1, 11523-7237-3, 11523-7237-5, 11523-7237-6, 11523-7237-7, 11523-7237-8, 11523-7237-9 +41 more
- UNII
- 7AJO3BO7QN
- Drugcharacterization
- 2
- Medicinalproduct
- ENSURE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Activesubstance
- Activesubstancename
- AMINO ACIDS\DEXTROSE\ELECTROLYTES NOS\SOYBEAN OIL\VITAMINS
- Drugcharacterization
- 2
- Medicinalproduct
- IMODIUM
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Activesubstance
- Activesubstancename
- LOPERAMIDE HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA075232, NDA019487, NDA021140
- Brand name
- IMODIUM A-D, IMODIUM MULTI-SYMPTOM RELIEF
- Generic name
- LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE
- Manufacturer name
- Kenvue Brands LLC
- Product NDC
- 50580-317, 50580-134, 50580-338
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Substance name
- LOPERAMIDE HYDROCHLORIDE, DIMETHICONE
- RxCUI
- 978010, 978013, 1250685, 1250693, 978001, 1426827
- SPL ID
- 3f75a619-8881-0bb3-e063-6394a90a1bcc, 3f73b325-ad6b-8e65-e063-6394a90a361e, 598d9530-ac42-e032-e063-6394a90a1edc
- SPL set ID
- 01da76d0-1979-4c45-9d39-c72ae4e4ffe2, 76a976d5-8bee-4158-a94d-7fbfc5544fd4, ecb91e47-2b0c-47c8-9256-4623d8bc825e
- Package NDC
- 50580-317-01, 50580-317-03, 50580-317-04, 50580-317-05, 50580-317-06, 50580-317-12, 50580-134-04, 50580-134-44, 50580-134-08, 50580-338-12, 50580-338-18, 50580-338-42, 50580-338-30, 50580-338-60, 50580-338-61, 50580-338-64, 50580-338-06, 50580-338-07, 50580-338-52, 50580-338-51, 50580-338-50
- UNII
- 77TI35393C, 92RU3N3Y1O
- Nui
- N0000010282
- Pharm class pe
- Skin Barrier Activity [PE]
- Drugcharacterization
- 2
- Medicinalproduct
- POTASSIUM CHLORIDE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Activesubstance
- Activesubstancename
- POTASSIUM CHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA210395, ANDA214422, ANDA210200, ANDA210766, ANDA077419, ANDA209922, ANDA214108, ANDA209786, ANDA211667, ANDA080205, ANDA202868, ANDA211992, ANDA076368, ANDA218733, ANDA211797, ANDA210902, NDA208019, ANDA214892, ANDA211087, ANDA210921, ANDA212987, ANDA212346, ANDA216156, ANDA209688, ANDA208864, ANDA211648, ANDA214686, NDA019904, ANDA208445, ANDA074726, ANDA209314, NDA019123, ANDA210241, ANDA203002, ANDA217412, ANDA213062, ANDA210733, NDA206814, ANDA202128, ANDA215725 +21 more
- Brand name
- POTASSIUM CHLORIDE, KALI MURIATICUM, SORE THROAT 911, POTASSIUM CHLORIDE EXTENDED RELEASE, POTASSIUM CHLORIDE EXTENDED-RELEASE, KLOR-CON, POKONZA POTASSIUM CHLORIDE, KLOR-CON M, KALIUM MURIATICUM 6X, KALI MURIATICUM KIT REFILL, POTASSIUM CHLORIDE FOR ORAL SOLUTION, POKONZA, D-125
- Generic name
- POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE
- Manufacturer name
- Zydus Lifesciences Limited, Hyland's Inc., Zydus Pharmaceuticals (USA) Inc., Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, PAI Holdings, LLC dba PAI Pharma, Actavis Pharma, Inc., Solco Healthcare LLC, Northstar Rx LLC, Lupin Pharmaceuticals,Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Hospira, Inc., Sun Pharmaceutical Industries, Inc., Boiron, Macleods Pharmaceuticals Limited, Granules Pharmaceuticals Inc., Amneal Pharmaceuticals LLC, Genus Lifesciences Inc., Guardian Drug Company, Fresenius Kabi USA, LLC, Aurobindo Pharma Limited, BPI Labs LLC, Upsher-Smith Laboratories, LLC, Adare Pharmaceuticals Inc, Kesin Pharma Corporation, BluePoint Laboratories, XLCare Pharmaceuticals, Inc., Baxter Healthcare Corporation, Upsher-SmithLaboratories, LLC, Slate Run Pharmaceuticals, LLC, Lupin Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Novel Laboratories, Inc., Dr. Reddys Laboratories, Inc., Strides Pharma Science Limited, Carwin Pharmaceutical Associates, LLC, Amneal Pharmaceuticals of New York LLC, Major Pharmaceuticals, Advagen Pharma Ltd +20 more
- Product NDC
- 70771-1599, 70771-1600, 54973-5224, 68382-740, 68382-861, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 0121-0948, 0121-4948, 0121-1896, 0121-2847, 62037-560, 62037-559, 43547-549, 43547-551, 43547-550, 72603-407, 43386-168, 43386-169, 23155-856, 0409-6635, 0409-6651, 0409-6653, 16714-824, 31722-494, 31722-495, 63304-987, 0220-2952, 33342-511, 33342-512, 70010-021, 70010-022, 60219-1617, 0220-2891, 64950-321, 53041-680, 53041-681 +132 more
- Product type
- HUMAN PRESCRIPTION DRUG, HUMAN OTC DRUG
- Route
- ORAL, TOPICAL, INTRAVENOUS, SUBLINGUAL, PARENTERAL
- Substance name
- POTASSIUM CHLORIDE, POTASSIUM CATION, DEXTROSE MONOHYDRATE
- RxCUI
- 1801294, 1801298, 403888, 1867544, 312515, 314182, 312504, 315183, 1860132, 1860136, 1860139, 312529, 628953, 312507, 1860239, 1860241, 1860463, 1860466, 309783, 2566844, 198116, 628958, 832718, 2734000, 2734004, 832731, 1801295, 1801299, 2693253, 2729280, 2729282, 1867547, 2665269, 2665275, 204520
- SPL ID
- c6b38e40-cd5a-41ed-92d6-eb25e9c0c725, f032ca21-e3ef-78b6-e053-2a95a90af8c4, 5e98c67f-9957-446f-bcf6-4ed08def954f, 54ef7636-02b5-4062-9171-625d089ebfce, 58c7eab4-f697-478c-be72-4cba3e74dc2c, 484de8df-472f-385d-e063-6394a90a4873, f5027a39-0ab3-4d01-9f7a-3737c7e8e852, 57df625b-891f-4826-a64b-46db5e64378e, f704b746-ab75-4484-8704-5baa94a07750, 40906ffd-2143-5419-e063-6294a90a8f27, b48fb85d-87f5-0c70-e053-2a95a90a7011, 10f4ff2b-8d6f-496d-af9b-fd98bf2d5afa, 6367e84e-17df-4c2a-ba38-ce75e4fe1c96, 1df016a5-65cd-49d8-ae08-06c5ddfc94b5, 7162658b-9e13-487e-bcf1-eda778fa3ac0, 0a1f3d5d-13ce-97b3-e063-6394a90aa250, 0a0e1894-0bee-949b-e063-6394a90a60a2, 89d827c8-91af-4bfd-a846-62e55824e983, f33d5a34-e5e7-a85f-e053-2995a90a6db3, d8dc08f5-f4d7-4474-807a-c189b577966d, 07d90edc-88ec-06a4-e063-6294a90ae585, 015c512b-8162-47af-9181-69065eef98fa, 859606e1-12d2-4eff-b6f3-4fa59c4da89b, fdab4887-b1a0-49d9-8bf4-07fd86ec6552, 771b8cdf-5287-4678-af79-7dc0c78245cc, 43cc6b36-fcf7-4e43-b66a-00eecc48d0a7, e0562a05-4359-4256-87e3-fcde65a008cd, fa0a4b99-d041-42d8-843d-e7dbead01d89, 0a0e390d-fe60-9dc6-e063-6294a90a5f58, d5ffd201-1ecb-4326-93fc-cc25b128a71c, 57726ba4-17f1-4613-8ab9-e64f3f155e8e, 0e920885-4086-c99c-e063-6294a90aaa67, 0cf861f5-7a8c-9ba4-e063-6294a90a601f, 137da9b4-83f0-355f-e063-6294a90af512, 42ebb029-df0e-9096-e063-6294a90a9dcc, 32424946-c3ae-434b-844c-5b4cdb1f605e, 4cf18d0e-1854-48fb-b711-49b2a3042ae4, 0a0e30cc-ad76-8cf3-e063-6394a90a974d, 37302db1-d7cc-4b79-8b3e-f14d40342ef4, 39990061-98d4-6669-e063-6394a90ae067 +59 more
- SPL set ID
- 099c3a36-f460-4191-80e5-0c4153a5c713, 2e8a4762-d28d-4b64-892f-913e04d18d2d, 31e02249-7984-4b8f-9e37-2b79b708ac08, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373321f-533a-4ab4-8bcd-8bde15371a09, 9ff8ff03-5921-cb3c-e053-2a95a90a094b, e848477f-b10d-4249-b322-b70cd6a062de, ed5baaf6-270b-4dd3-b100-36030c0098fc, f704b746-ab75-4484-8704-5baa94a07750, fbed8c29-b3f1-4e53-b290-6f717290cecf, 28c49165-d8c9-443a-b000-953b8e1ec55c, 23b10bd6-11bc-495e-bb05-ec332a9b3f21, 559a0a8c-a8fe-40a5-b196-21f9308780ab, dded25a9-3df4-463a-8685-d2bc03ea4edb, fb2f6e74-4c1f-40c5-88a1-b88c069d4c75, 0a1f2f64-3b0b-5e5c-e063-6294a90a7185, 860887e7-7eaf-78c2-e053-2991aa0a9a75, 89d827c8-91af-4bfd-a846-62e55824e983, 9f8d2886-9ecd-4cbf-a84a-2d221cb3497c, f9965f73-e189-423f-bd10-c4a0ed12b485, caaad470-7be1-11e6-b409-424c58303031, 23d818e7-c076-40de-8dc1-0b51ba4be96a, 3d460e84-27a0-485c-8b11-58d03d9064aa, b19a3fbf-cdbb-4f86-ac61-5dfb07e0a51a, 3849b89c-c309-46fb-a1e2-53ff0c65077f, d43beabe-b801-4319-ad36-9a80856b94bd, e0562a05-4359-4256-87e3-fcde65a008cd, 55d9ae37-4553-47e7-a2e3-86b48b5227cd, 8608f3dd-31bf-0182-e053-2991aa0a1030, aeb2e14e-cd7c-49d0-a15f-fbbe89a03c6b, 02707146-331f-4511-a187-0152fc8bca85, 4d90d03d-7f0e-4d49-9e80-628dbc7165c0, 22edb0e6-4e45-4e91-aead-3581cca293a0, 25c2b417-eeea-4ba6-8eb9-a7d8a08c6093, 3709ee9a-f885-4a75-ab51-36e9e1ef0427, 7fd82f08-8ad0-4ee2-8eb6-5c973f98baee, 092ddee4-572d-4771-8d95-880cea01097e, 86086aab-c411-7cf2-e053-2991aa0a81bd, 51586c47-1aff-4ce6-8030-89f9eb1bc9ac, ad584ce4-a64d-4851-80e9-0eeedc0b9d06 +59 more
- Package NDC
- 70771-1599-1, 70771-1599-0, 70771-1600-1, 70771-1600-5, 70771-1600-0, 54973-5224-1, 54973-5224-2, 68382-861-01, 68382-861-10, 68382-740-01, 68382-740-05, 68382-740-10, 31722-133-01, 31722-133-05, 31722-134-01, 31722-135-01, 31722-135-05, 42806-094-99, 42806-094-30, 42806-094-01, 35484-204-21, 0121-0948-16, 0121-4948-15, 0121-4948-94, 0121-4948-40, 0121-4948-50, 0121-4948-80, 0121-4948-00, 0121-1896-30, 0121-1896-40, 0121-1896-50, 0121-1896-00, 0121-2847-16, 0121-2847-15, 0121-2847-94, 0121-2847-40, 0121-2847-50, 0121-2847-80, 0121-2847-00, 62037-559-01 +380 more
- UNII
- 660YQ98I10, 295O53K152, LX22YL083G
- Nui
- M0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288
- Pharm class cs
- Potassium Compounds [CS]
- Pharm class epc
- Potassium Salt [EPC], Osmotic Laxative [EPC]
- Pharm class pe
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
- Pharm class moa
- Osmotic Activity [MoA]
- Drugcharacterization
- 2
- Medicinalproduct
- PYRIDOXINE HYDROCHLORIDE
- Drugseparatedosagenumb
- 1
- Drugdosagetext
- UNK
- Drugadministrationroute
- 065
- Activesubstance
- Activesubstancename
- PYRIDOXINE HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA080618
- Brand name
- PYRIDOXINE HYDROCHLORIDE
- Generic name
- PYRIDOXINE HYDROCHLORIDE
- Manufacturer name
- Fresenius Kabi USA, LLC
- Product NDC
- 63323-180
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Substance name
- PYRIDOXINE HYDROCHLORIDE
- RxCUI
- 312736
- SPL ID
- 621c0b5c-be50-4bb5-9475-6acba6114cbe
- SPL set ID
- a56d11c0-b033-4201-85ff-fc710506481a
- Package NDC
- 63323-180-00, 63323-180-01
- UNII
- 68Y4CF58BV
- Summary
- Narrativeincludeclinical
- CASE EVENT DATE: 20260925