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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020235 | VIATRIS | 1993-12-30 | 4 |
| NDA 020882 | VIATRIS | 1998-10-09 | 2 |
| NDA 021129 | VIATRIS | 2000-03-02 | 3 |
| ANDA 075350 | ACTAVIS ELIZABETH | 2003-09-12 | 16 |
| ANDA 075477 | CSPC OUYI | 2005-03-23 | 12 |
| ANDA 075360 | GRANULES | 2005-04-06 | 10 |
| ANDA 077662 | GLENMARK PHARMS LTD | 2006-08-18 | 15 |
| ANDA 077525 | SUN PHARM INDS LTD | 2006-08-24 | 3 |
| ANDA 077242 | SUN PHARM INDS LTD | 2006-08-24 | 3 |
| ANDA 078428 | AMNEAL PHARMS NY | 2007-07-25 | 15 |
| ANDA 078787 | AUROBINDO PHARMA | 2008-01-31 | 25 |
| ANDA 090705 | INVAGEN PHARMS | 2009-12-30 | 15 |
| ANDA 090858 | ALKEM | 2010-12-17 | 60 |
| NDA 022544 | ALMATICA | 2011-01-28 | 5 |
| ANDA 078926 | ZYDUS PHARMS USA INC | 2011-02-11 | 10 |
| ANDA 090007 | MARKSANS PHARMA | 2011-07-21 | 23 |
| ANDA 200651 | AUROBINDO PHARMA LTD | 2011-10-06 | 24 |
| ANDA 076403 | ACELLA PHARMS LLC | 2012-05-01 | 3 |
| ANDA 202764 | INVAGEN PHARMS | 2012-10-16 | 5 |
| ANDA 203244 | STRIDES PHARMA | 2013-07-12 | 15 |
| ANDA 206402 | ALKEM LABS LTD | 2015-12-23 | 12 |
| ANDA 205101 | SCIEGEN PHARMS | 2016-02-04 | 36 |
| ANDA 204989 | SCIEGEN PHARMS | 2016-02-18 | 70 |
| ANDA 091286 | AJENAT PHARMS | 2016-03-14 | 5 |
| ANDA 207099 | RISING | 2017-03-24 | 18 |
| ANDA 207057 | CSPC OUYI | 2017-10-26 | 21 |
| ANDA 206943 | STRIDES PHARMA | 2018-05-14 | 30 |
| ANDA 211314 | STRIDES PHARMA | 2018-10-16 | 8 |
| ANDA 211330 | PAI HOLDINGS PHARM | 2019-12-03 | 4 |
| ANDA 213603 | ZHEJIANG YONGTAI | 2020-08-17 | 6 |
| ANDA 214956 | ASCENT PHARMS INC | 2021-05-10 | 25 |
| ANDA 214957 | ASCENT PHARMS INC | 2021-10-01 | 29 |
| ANDA 216492 | RUBICON RESEARCH | 2023-01-18 | 2 |
| ANDA 217116 | GRANULES | 2023-03-28 | 3 |
| ANDA 217546 | PHARMOBEDIENT | 2023-05-12 | 3 |
| ANDA 217995 | RISING | 2023-07-19 | 5 |
| ANDA 203934 | ZYDUS PHARMS | 2024-01-24 | 10 |
| ANDA 216252 | EPIC PHARMA LLC | 2024-02-26 | 2 |
| ANDA 219319 | SENORES PHARMS | 2025-08-07 | 7 |
| ANDA 219814 | PRINSTON INC | 2026-03-06 | 3 |
Showing 40 of 49 applications.
Official labeling on DailyMed
- GABAPENTIN CAPSULE [REMEDYREPACK INC.] · version 2 · 2026-09-14
- GABAPENTIN CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-09-11
- GABAPENTIN TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] · version 1 · 2026-09-10
- GABAPENTIN CAPSULE [NUCARE PHARMACEUTICALS,INC.] · version 6 · 2026-09-07
- GABAPENTIN TABLET [PHOENIX RX LLC] · version 1 · 2026-09-04
- GABAPENTIN CAPSULE [REMEDYREPACK INC.] · version 5 · 2026-09-02
- GABAPENTIN CAPSULE [REMEDYREPACK INC.] · version 1 · 2026-09-02
- GABAPENTIN CAPSULE [REMEDYREPACK INC.] · version 1 · 2026-08-31
- GABAPENTIN CAPSULE [REMEDYREPACK INC.] · version 22 · 2026-08-31
- GABAPENTIN CAPSULE [BRYANT RANCH PREPACK] · version 102 · 2026-08-28
- GABAPENTIN CAPSULE [BRYANT RANCH PREPACK] · version 102 · 2026-08-28
- GABAPENTIN CAPSULE [BRYANT RANCH PREPACK] · version 102 · 2026-08-28
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.