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Active ingredient

Gabapentin

582 finished FDA listings contain Gabapentin as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
GABAPENTIN, GABAPENTIN ENACARBIL
Dosage forms
Capsule, Solution, Suspension, Tablet, Tablet, Coated, Tablet, Extended Release, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
92
Strengths listed
100 mg/1 · 200 mg/1 · 250 mg/5ml · 300 mg/1 · 400 mg/1 · 450 mg/1 · 50 mg/ml · 600 mg/1 · 750 mg/1 · 800 mg/1 · 900 mg/1
Brand names in FDA listings
Gabarone, Gralise, Horizant, Neurontin, Relgaabi

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 25480

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 020235VIATRIS1993-12-304
NDA 020882VIATRIS1998-10-092
NDA 021129VIATRIS2000-03-023
ANDA 075350ACTAVIS ELIZABETH2003-09-1216
ANDA 075477CSPC OUYI2005-03-2312
ANDA 075360GRANULES2005-04-0610
ANDA 077662GLENMARK PHARMS LTD2006-08-1815
ANDA 077525SUN PHARM INDS LTD2006-08-243
ANDA 077242SUN PHARM INDS LTD2006-08-243
ANDA 078428AMNEAL PHARMS NY2007-07-2515
ANDA 078787AUROBINDO PHARMA2008-01-3125
ANDA 090705INVAGEN PHARMS2009-12-3015
ANDA 090858ALKEM2010-12-1760
NDA 022544ALMATICA2011-01-285
ANDA 078926ZYDUS PHARMS USA INC2011-02-1110
ANDA 090007MARKSANS PHARMA2011-07-2123
ANDA 200651AUROBINDO PHARMA LTD2011-10-0624
ANDA 076403ACELLA PHARMS LLC2012-05-013
ANDA 202764INVAGEN PHARMS2012-10-165
ANDA 203244STRIDES PHARMA2013-07-1215
ANDA 206402ALKEM LABS LTD2015-12-2312
ANDA 205101SCIEGEN PHARMS2016-02-0436
ANDA 204989SCIEGEN PHARMS2016-02-1870
ANDA 091286AJENAT PHARMS2016-03-145
ANDA 207099RISING2017-03-2418
ANDA 207057CSPC OUYI2017-10-2621
ANDA 206943STRIDES PHARMA2018-05-1430
ANDA 211314STRIDES PHARMA2018-10-168
ANDA 211330PAI HOLDINGS PHARM2019-12-034
ANDA 213603ZHEJIANG YONGTAI2020-08-176
ANDA 214956ASCENT PHARMS INC2021-05-1025
ANDA 214957ASCENT PHARMS INC2021-10-0129
ANDA 216492RUBICON RESEARCH2023-01-182
ANDA 217116GRANULES2023-03-283
ANDA 217546PHARMOBEDIENT2023-05-123
ANDA 217995RISING2023-07-195
ANDA 203934ZYDUS PHARMS2024-01-2410
ANDA 216252EPIC PHARMA LLC2024-02-262
ANDA 219319SENORES PHARMS2025-08-077
ANDA 219814PRINSTON INC2026-03-063

Showing 40 of 49 applications.

Official labeling on DailyMed

Showing the 12 most recent of 400 labels.

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