Deafness, Tinnitus
Drugs: BUPROPION HYDROCHLORIDE
- Safetyreportversion
- 1
- Safetyreportid
- 27325227
- Primarysourcecountry
- EU
- Occurcountry
- EU
- Transmissiondateformat
- 102
- Transmissiondate
- 20261010
- Reporttype
- 1
- Serious
- 1
- Seriousnessdeath
- 2
- Seriousnesslifethreatening
- 2
- Seriousnesshospitalization
- 2
- Seriousnessdisabling
- 2
- Seriousnesscongenitalanomali
- 2
- Seriousnessother
- 1
- Receivedateformat
- 102
- Receivedate
- 20260930
- Receiptdateformat
- 102
- Receiptdate
- 20260930
- Fulfillexpeditecriteria
- 1
- Companynumb
- EU-GSK-DE2026EME128521
- Primarysource
- Reportercountry
- EU
- Qualification
- 1
- Sender
- Sendertype
- 6
- Senderorganization
- GLAXOSMITHKLINE
- Receiver
- Receivertype
- 6
- Receiverorganization
- FDA
- Patient
- Patientonsetage
- 70
- Patientonsetageunit
- 801
- Patientsex
- 1
- Reaction
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Deafness
- Reactionoutcome
- 6
- Reactionmeddraversionpt
- 29.0
- Reactionmeddrapt
- Tinnitus
- Reactionoutcome
- 6
- Drug
- Drugcharacterization
- 1
- Medicinalproduct
- BUPROPION HYDROCHLORIDE
- Drugbatchnumb
- UNK
- Drugauthorizationnumb
- 018644
- Drugstructuredosagenumb
- 150
- Drugstructuredosageunit
- 003
- Drugseparatedosagenumb
- 1
- Drugintervaldosageunitnumb
- 1
- Drugintervaldosagedefinition
- 804
- Drugdosagetext
- 150 MG, QD
- Drugindication
- Adjustment disorder with depressed mood
- Actiondrug
- 5
- Drugrecurreadministration
- 3
- Drugadditional
- 3
- Activesubstance
- Activesubstancename
- BUPROPION HYDROCHLORIDE
- Harmonized identifiers (openFDA)
- Application number
- ANDA202304, ANDA206975, ANDA207389, ANDA210015, ANDA211347, ANDA208652, ANDA075584, ANDA205794, ANDA207479, ANDA076143, ANDA075932, ANDA210497, NDA021515, ANDA216051, ANDA090693, ANDA075491, ANDA206556, ANDA090325, ANDA203013, ANDA211200, ANDA215568, ANDA076711, ANDA206122, ANDA207224, ANDA208606, ANDA206674, ANDA077415, ANDA079095, ANDA216766, NDA022497, NDA020358, ANDA216800, ANDA200695, ANDA217898
- Brand name
- BUPROPION HYDROCHLORIDE SR, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE XL, BUPROPION HYDROCHLORIDE (XL), WELLBUTRIN XL, BUPROPION HYDROCHLORIDE (SR), FORFIVO XL, WELLBUTRIN SR
- Generic name
- BUPROPION HYDROCHLORIDE
- Manufacturer name
- Solco Healthcare US LLC, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., CIPLA USA INC.,, Slate Run Pharmaceuticals, LLC, Vitruvias Therapeutics, Amici Pharma, Inc., Dr. Reddys Laboratories Inc., ScieGen Pharmaceuticals,Inc., Radha Pharmaceuticals, Inc., BluePoint Laboratories, Epic Pharma LLC, Epic Pharma, LLC, Accord Healthcare Inc., Bausch Health US LLC, Mullan Pharmaceutical Inc., Aurobindo Pharma Limited, Lupin Pharmaceuticals, Inc., Exelan Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Oryza pharmaceuticals Inc., Granules Pharmaceuticals Inc., Amneal Pharmaceuticals of New York LLC, ScieGen Pharmaceuticals, Inc., Dr. Reddy's Laboratories Inc, Quallent Pharmaceuticals Health LLC, Apotex Corp, Lannett Company Inc., Cadila Pharmaceuticals Limited, Cipla USA., Inc., Cipla USA Inc.,, Actavis Pharma, Inc., RADHA PHARMACEUTICALS, INC., Upsher-Smith Laboratories, LLC, MAJOR PHARMACEUTICALS, GlaxoSmithKline LLC, Camber Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc., Chartwell RX, LLC, Alembic Pharmaceuticals Inc.
- Product NDC
- 43547-288, 43547-289, 43547-290, 23155-191, 23155-192, 69097-917, 69097-918, 70436-010, 70436-011, 70436-058, 70436-059, 70436-060, 69680-157, 69680-158, 69292-601, 69292-602, 43598-536, 43598-537, 43598-538, 50228-144, 50228-145, 77771-174, 77771-175, 77771-176, 68001-308, 68001-309, 42806-410, 42806-415, 42806-411, 42806-424, 42806-425, 42806-426, 16729-443, 16729-444, 0187-0730, 0187-0731, 83301-0024, 83301-0025, 59651-511, 59651-512 +61 more
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- BUPROPION HYDROCHLORIDE
- RxCUI
- 993503, 993518, 993536, 993687, 993691, 993541, 993557, 993545, 993564, 1801289, 1232585, 1232591, 993511, 993528, 993537
- SPL ID
- 9424dd2e-19ad-4f3d-b533-ba504a18ff77, b72f6124-e8e4-42b7-8095-771ff429e936, c1d5cac6-7ca2-4b55-90c3-5ef51df0a1ee, 1b0d6505-54e6-a28f-e063-6294a90aae71, 1b0de43f-05c2-aed6-e063-6394a90ac5df, c7d45984-a653-4be6-9b1c-986a553e4e42, 3e54a2cc-6e29-482c-a6ee-451b3a1a15f3, 6364d3de-085f-44f8-d1e4-e6bfc5a854a7, 1105c206-a0be-4ea0-a6e3-1371ac2df153, 5a38f43e-ac1b-4cf2-b454-79d08f5dd555, 44a42976-faae-065e-e063-6394a90aa7da, af1a3522-8180-4e3f-a2fc-c9fe143997a3, 50036e03-a443-a430-e063-6394a90a72c7, 4092a3ea-403d-7a91-e063-6394a90a8ddf, 22308f71-fc56-430d-b559-bed47e17a46c, 4990307c-8f79-4a7b-e063-6294a90a7b94, cc344f7c-0eb3-4e63-a09e-b682acca2bb5, 5e0af71c-ee29-4550-84d5-fde1e1352d47, 8ab2cb88-9bc6-4c0c-a97b-3098dbc11a7f, 9fff6e28-19e0-43ad-85c8-57d111b990bb, b9ab1deb-dba4-4403-9121-936278cc4cfe, b09bdaa7-0871-4741-b5cd-dd30d683613c, 47afeb95-a677-8969-e063-6294a90a7b2d, 5a026e6e-9176-7f54-e063-6394a90a370a, cb660c34-cfd0-4598-a767-db8a82e087e0, d9b7b0d0-71db-578b-e053-2a95a90a8514, 4486fd29-bab2-59ee-e063-6294a90a4fd2, 065bb407-cb85-49d0-ac09-7a379cd2a293, 9d602b2e-4f88-650d-f47e-d63fb7aacf92, 6fb20e45-74e9-4038-9db0-9eaf24b5560a, 5e3c0247-0f79-454e-b14d-1e7dfd1a765e, b271a757-875d-4349-8c40-a047c10cbd1b, fff2e22d-64c2-425f-823f-a34664d4b1aa, 9c292b5a-2a09-4f01-b1fe-8652dd577542, a9b85841-5a69-4df1-a22d-3d4cf174e9a6, 5fb023e1-b35a-40c0-a5aa-1e383dcd4d86, 4bde5d2f-85ee-95da-e063-6394a90aab81, 6b52ebe6-6537-4e42-896b-b0cb5697639d, 4bde68a6-0945-b21f-e063-6394a90a3bc4, 3bf617e4-22ef-4237-b80b-24c4c1b1bfda +9 more
- SPL set ID
- 39b2d509-1281-4464-9cf1-a94bbc18b84b, 9196568e-aec8-4d56-993e-4cbb78d4a3a6, e4100232-a25d-4468-9057-af7e66205154, 06d4d890-11ed-4f31-8778-c73432e3ea69, 7c4313fa-bb29-dd50-e053-2991aa0a3005, f53704b2-3d3c-47e8-9fd6-a0f5240c0593, fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c75, 6948f63b-599c-4956-a249-e9544beda9fc, 05f82eca-cc87-4580-acd7-e6491c651881, 161637d2-bc9d-4a2b-ad1f-6cc39ffd69ce, 7d035056-44ab-444d-9d27-125b3f571140, 9fb44e96-6160-4a4a-90cb-91764c0dcd89, f8ad76a2-9f75-4660-973d-34402f314e9c, 34686e9d-c106-4276-8b47-7460cca8860e, a435da9d-f6e8-4ddc-897d-8cd2bf777b21, 75b1e027-4c5d-46e5-98ee-033e67bd411c, cc344f7c-0eb3-4e63-a09e-b682acca2bb5, 1af14d2e-c64d-44b7-a402-8869e8e30661, 6563b923-269f-40c3-b992-cbacdfca6e16, 8a0781c0-e7d5-498e-b7d3-d6bd457f175f, 8f86f677-2ebd-43c4-b2dd-2e07d4d54147, ef0bb8f2-7710-4236-8b47-57b74c8bca3e, 004d8121-59d4-46c4-acb8-b2dd097bf556, d9eb0939-63c1-48c4-a444-a899d7924d06, e962fb9a-d9fb-49c5-a8b4-0b355b8f829b, 2bb61b34-653a-43b4-9682-705d5b82d18e, 8069c521-c49a-4b6d-baa8-4b0be897d585, 56df4e22-81ca-48a4-a8e2-038448417355, 86530199-999b-9f92-b1bc-b8515ec829f3, c2cf79d7-1aba-4391-980b-5e218781f7c6, 15c4e95a-d203-4caf-b6c7-44792355cb76, 178c7129-a752-4ad9-ac82-4473e23bbacc, 33210109-2ddb-4b0f-a45e-988e493ca628, 0abd64f7-5142-48f6-a487-3f5bdc3400de, 9d2c209b-248e-4e26-9cde-fe0abe4428c1, fddc9630-2f9a-4104-888f-3714587d4fe7, f79d1422-a9b6-41c2-a46d-22886605f94d, cec41945-8d64-4793-8784-4c2b8ec37b0f, f56ccdb1-f9d9-3e5f-e053-2995a90a8f16, 16a788ff-8bd5-4f70-a3fd-a89db019e435 +9 more
- Package NDC
- 43547-288-06, 43547-288-09, 43547-288-10, 43547-288-50, 43547-289-06, 43547-289-09, 43547-289-10, 43547-289-25, 43547-289-50, 43547-290-06, 43547-290-09, 43547-290-10, 43547-290-50, 23155-191-10, 23155-191-01, 23155-192-10, 23155-192-01, 69097-917-02, 69097-917-07, 69097-917-15, 69097-918-02, 69097-918-07, 69097-918-15, 70436-010-04, 70436-010-06, 70436-010-02, 70436-011-04, 70436-011-06, 70436-011-02, 70436-058-05, 70436-058-01, 70436-058-02, 70436-059-05, 70436-059-01, 70436-059-22, 70436-059-02, 70436-060-05, 70436-060-01, 70436-060-02, 69680-157-30 +221 more
- UNII
- ZG7E5POY8O