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Active ingredient

Bupropion

347 finished FDA listings contain Bupropion as their only active ingredient; 3 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
BUPROPION, BUPROPION HYDROBROMIDE, BUPROPION HYDROCHLORIDE
Dosage forms
Tablet, Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
79
Strengths listed
100 mg/1 · 150 mg/1 · 174 mg/1 · 200 mg/1 · 300 mg/1 · 348 mg/1 · 450 mg/1 · 522 mg/1 · 75 mg/1
Brand names in FDA listings
Aplenzin, Bupropion, Bupropion Hcl Er (Xl), Bupropion Hydrochloride (Sr), Bupropion Hydrochloride (Xl), Bupropion Hydrochloride Sr, Bupropion Hydrochloride Xl, Forfivo Xl, Wellbutrin Sr, Wellbutrin Xl

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 42347

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020358GLAXOSMITHKLINE1996-10-043
ANDA 075584SENORES PHARMS2000-02-072
ANDA 075491AUROBINDO PHARMA USA2000-04-177
NDA 021515BAUSCH2003-08-282
ANDA 075932EPIC PHARMA LLC2003-11-254
ANDA 076143APOTEX2006-01-1734
ANDA 077415IMPAX LABS2006-12-152
ANDA 077715ACTAVIS LABS FL INC2007-06-134
NDA 022108BAUSCH2008-04-236
ANDA 077285WATSON LABS INC2008-08-154
ANDA 079094ACTAVIS LABS FL INC2009-03-242
ANDA 079095ACTAVIS LABS FL INC2009-03-2410
ANDA 078866SUN PHARM2010-04-066
ANDA 090325AUROBINDO PHARMA USA2010-04-083
NDA 022497TWI PHARMS2011-11-103
ANDA 201567ZYDUS PHARMS2014-01-175
ANDA 202304PRINSTON INC2015-05-2611
ANDA 206674INVAGEN PHARMS2016-02-094
ANDA 205794SCIEGEN PHARMS2016-03-0133
ANDA 206122SCIEGEN PHARMS2016-08-173
ANDA 206975HERITAGE PHARMA2016-08-1920
ANDA 206556INVAGEN PHARMS2016-08-265
ANDA 090693LUPIN2017-04-0622
ANDA 207479SCIEGEN PHARMS2017-04-1225
ANDA 207224ANBISON LAB2017-06-304
ANDA 208652SINOTHERAPEUTICS INC2017-08-218
ANDA 207389INVAGEN PHARMS2017-09-183
ANDA 210081TWI PHARMS2017-11-035
ANDA 203013ALEMBIC2018-06-086
ANDA 210015YICHANG HUMANWELL2018-06-1413
ANDA 211347YICHANG HUMANWELL2018-10-1610
ANDA 210497ACCORD HLTHCARE2018-10-3118
ANDA 211020GRAVITI PHARMS2019-01-287
ANDA 211200ZHEJIANG JUTAI PHARM2019-09-052
ANDA 208606CADILA PHARMS LTD2020-01-164
ANDA 215568GRANULES2022-02-0216
ANDA 216800ANNORA PHARMA2023-05-3118
ANDA 218385GRANULES2024-10-173
ANDA 217898ANNORA PHARMA2025-10-012
ANDA 218567MACLEODS PHARMS2026-06-233

Showing 40 of 44 applications.

Official labeling on DailyMed

Showing the 12 most recent of 246 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.