FDA Orange Book · active-ingredient family
Gabapentin
Gabapentin: 4 brands, 70 generics; first approved Dec 30, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 70 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
70
Listed patents
0
Presentations
182
Brand (NDA) products
Originator applications
- ALMATICANDA 02254420115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB2 600MG TABLET ORAL Rx AB2 450MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 900MG TABLET ORAL Rx AB - VIATRISNDA 0211292000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - NEURONTINRLDVIATRISNDA 02088219982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - NEURONTINRLDVIATRISNDA 02023519933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB
Generic (ANDA) products (70)
Abbreviated applications
- GABAPENTINACTAVIS ELIZABETHANDA 20361120262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB2 600MG TABLET ORAL Rx AB2 - GABAPENTINPRINSTON INCANDA 21981420263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINSCIEGEN PHARMSANDA 21849120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB2 600MG TABLET ORAL Rx AB2 - GABAPENTINSENORES PHARMSANDA 21931920254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - GABAPENTINSTRIDES PHARMAANDA 21131320244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 100MG TABLET ORAL Rx AB1 400MG TABLET ORAL Rx AB1 - GABAPENTINABON PHARMS LLCANDA 2036432024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB2 - GABAPENTINIPCA LABS LTDANDA 20985520242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINLAURUSANDA 21796520242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINANNORA PHARMAANDA 21807520242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB2 600MG TABLET ORAL Rx AB2 - GABAPENTINEPIC PHARMA LLCANDA 21625220242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB2 600MG TABLET ORAL Rx AB2 - GABAPENTINZYDUS PHARMSANDA 20393420245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG TABLET ORAL Rx AB2 600MG TABLET ORAL Rx AB2 450MG TABLET ORAL Rx AB 750MG TABLET ORAL Rx AB 900MG TABLET ORAL Rx AB - GABAPENTINANNORA PHARMAANDA 2176822024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - GABAPENTINIPCA LABS LTDANDA 20892820233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINRISINGANDA 21799520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINLAURUSANDA 21754620233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINGRANULESANDA 21711620232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINRUBICON RESEARCHANDA 2164922023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - GABAPENTINASCENT PHARMS INCANDA 21495720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINASCENT PHARMS INCANDA 21495620213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINZHEJIANG YONGTAIANDA 21360320203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINPAI HOLDINGS PHARMANDA 2113302019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - GABAPENTINSTRIDES PHARMAANDA 21131420183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINLUPINANDA 20930620182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINSTRIDES PHARMAANDA 20694320183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINCHARTWELL RXANDA 09100820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINCSPC OUYIANDA 20705720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINRISINGANDA 20709920173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINTEVA PHARMS USAANDA 20580720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINAJENAT PHARMSANDA 0912862016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - SCIEGEN PHARMSANDA 20498920164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - GABAPENTINSCIEGEN PHARMSANDA 20510120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINALKEM LABS LTDANDA 20640220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINTAROANDA 07726120133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINSTRIDES PHARMAANDA 20324420132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET ORAL Rx AB1 600MG TABLET ORAL Rx AB1 - GABAPENTINTAROANDA 0766722013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Discontinued — - GABAPENTININVAGEN PHARMSANDA 20276420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINACELLA PHARMS LLCANDA 0764032012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - GABAPENTINAMNEAL PHARMSANDA 2020242012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - GABAPENTINAUROBINDO PHARMA LTDANDA 20065120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINMARKSANS PHARMAANDA 09000720113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINHIKMA PHARMSANDA 07878220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINMISSION PHARMACALANDA 0789742011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG/5ML SOLUTION ORAL Rx AA - GABAPENTINALLIEDANDA 09015820113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINZYDUS PHARMS USA INCANDA 07892620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINALKEMANDA 09085820103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINPHARMOBEDIENTANDA 09033520102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTININVAGEN PHARMSANDA 09070520093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINAUROBINDO PHARMAANDA 07878720083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINHIKMAANDA 07815020073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINAMNEAL PHARMS NYANDA 07842820073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINWATSON LABSANDA 07548520073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — - GABAPENTINAPOTEXANDA 07789420063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued — - GABAPENTINRUBICON RESEARCHANDA 07766120062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINSUN PHARM INDS LTDANDA 07724220063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINSUN PHARM INDS LTDANDA 07752520062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINGLENMARK PHARMS LTDANDA 07766220062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Rx AB1 800MG TABLET ORAL Rx AB1 - GABAPENTINSENORES PHARMSANDA 07687720062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINCHARTWELL RXANDA 07612020062 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINSANDOZANDA 07542820063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINSUN PHARM INDS LTDANDA 07660620053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINRANBAXYANDA 07660520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINSUN PHARM INDUSTRIESANDA 07653720053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINGRANULESANDA 07536020053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINSANDOZANDA 07553920053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINCSPC OUYIANDA 07547720053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - GABAPENTINTEVAANDA 07582720042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINACTAVIS ELIZABETHANDA 07569420042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINTEVA PHARMSANDA 07543520043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 300MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - GABAPENTINIVAX SUB TEVA PHARMSANDA 07601720045 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB1 300MG TABLET ORAL Rx — 400MG TABLET ORAL Rx AB1 600MG TABLET ORAL Discontinued — 800MG TABLET ORAL Discontinued — - GABAPENTINACTAVIS ELIZABETHANDA 07535020033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 300MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
33 yr 1 mo ago
Most recent approval
1 mo ago
Approvals span 1993–2026 across 74 FDA applications.
Brand (NDA) 45%
Generic (ANDA) 7095%
Gabapentin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
