FDA Orange Book
Generic for Neurontin
Neurontin contains gabapentin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Neurontin is gabapentin. 26 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AB1, AB2.
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Neurontin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 17 | AB |
| capsule, oral | 300MG | Marketed (Rx) | AB | 17 | AB |
| capsule, oral | 400MG | Marketed (Rx) | AB | 17 | AB |
| solution, oral | 250MG/5ML | Marketed (Rx) | AA | 7 | AA |
| tablet, oral | 600MG | Marketed (Rx) | AB1 | 19 | AB1, AB2 |
| tablet, oral | 800MG | Marketed (Rx) | AB1 | 13 | AB1 |
NDA 020235, 021129, 020882, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic gabapentin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 075350 | AB (A-rated, therapeutically equivalent) | September 12, 2003 | 100MG, 300MG, 400MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 075477 | AB (A-rated, therapeutically equivalent) | March 23, 2005 | 100MG, 300MG, 400MG |
| GRANULES INDIA LTD | 075360 | AB (A-rated, therapeutically equivalent) | April 6, 2005 | 100MG, 300MG, 400MG |
| GLENMARK PHARMACEUTICALS LTD | 077662 | AB1 (A-rated, therapeutically equivalent) | August 18, 2006 | 600MG, 800MG |
| RUBICON RESEARCH LTD | 077661 | AB1 (A-rated, therapeutically equivalent) | September 13, 2006 | 600MG, 800MG |
| AMNEAL PHARMACEUTICALS NY LLC | 078428 | AB (A-rated, therapeutically equivalent) | July 25, 2007 | 100MG, 300MG, 400MG |
| AUROBINDO PHARMA LTD | 078787 | AB (A-rated, therapeutically equivalent) | January 31, 2008 | 100MG, 300MG, 400MG |
| INVAGEN PHARMACEUTICALS INC | 090705 | AB (A-rated, therapeutically equivalent) | December 30, 2009 | 100MG, 300MG, 400MG |
| ALKEM LABORATORIES LTD | 090858 | AB (A-rated, therapeutically equivalent) | December 17, 2010 | 100MG, 300MG, 400MG |
| ZYDUS PHARMACEUTICALS USA INC | 078926 | AB1 (A-rated, therapeutically equivalent) | February 11, 2011 | 600MG, 800MG |
| MISSION PHARMACAL CO | 078974 | AA (A-rated, therapeutically equivalent) | February 18, 2011 | 250MG/5ML |
| PHARMAZONE | 090007 | AB (A-rated, therapeutically equivalent) | July 21, 2011 | 100MG, 300MG, 400MG |
| AUROBINDO PHARMA LTD | 200651 | AB1 (A-rated, therapeutically equivalent) | October 6, 2011 | 600MG, 800MG |
| AMNEAL PHARMACEUTICALS | 202024 | AA (A-rated, therapeutically equivalent) | March 23, 2012 | 250MG/5ML |
| ACELLA PHARMACEUTICALS LLC | 076403 | AA (A-rated, therapeutically equivalent) | May 1, 2012 | 250MG/5ML |
| STRIDES PHARMA GLOBAL PTE LTD | 203244 | AB1 (A-rated, therapeutically equivalent) | July 12, 2013 | 600MG, 800MG |
| ALKEM LABORATORIES LTD | 206402 | AB1 (A-rated, therapeutically equivalent) | December 23, 2015 | 600MG, 800MG |
| SCIEGEN PHARMACEUTICALS INC | 205101 | AB1 (A-rated, therapeutically equivalent) | February 4, 2016 | 600MG, 800MG |
| SCIEGEN PHARMACEUTICALS INC | 204989 | AB (A-rated, therapeutically equivalent) | February 18, 2016 | 100MG, 300MG, 400MG |
| AJENAT PHARMACEUTICALS LLC | 091286 | AA (A-rated, therapeutically equivalent) | March 14, 2016 | 250MG/5ML |
| RISING PHARMA HOLDINGS INC | 207099 | AB (A-rated, therapeutically equivalent) | March 24, 2017 | 100MG, 300MG, 400MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 207057 | AB1 (A-rated, therapeutically equivalent) | October 26, 2017 | 600MG, 800MG |
| STRIDES PHARMA GLOBAL PTE LTD | 206943 | AB (A-rated, therapeutically equivalent) | May 14, 2018 | 100MG, 300MG, 400MG |
| STRIDES PHARMA GLOBAL PTE LTD | 211314 | AB (A-rated, therapeutically equivalent) | October 16, 2018 | 100MG, 300MG, 400MG |
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC | 211330 | AA (A-rated, therapeutically equivalent) | December 3, 2019 | 250MG/5ML |
| ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD | 213603 | AB (A-rated, therapeutically equivalent) | August 17, 2020 | 100MG, 300MG, 400MG |
| ASCENT PHARMACEUTICALS INC | 214956 | AB (A-rated, therapeutically equivalent) | May 10, 2021 | 100MG, 300MG, 400MG |
| ASCENT PHARMACEUTICALS INC | 214957 | AB1 (A-rated, therapeutically equivalent) | October 1, 2021 | 600MG, 800MG |
| RUBICON RESEARCH LTD | 216492 | AA (A-rated, therapeutically equivalent) | January 18, 2023 | 250MG/5ML |
| GRANULES INDIA LTD | 217116 | AB1 (A-rated, therapeutically equivalent) | March 28, 2023 | 600MG, 800MG |
| PHARMOBEDIENT CONSULTING LLC | 217546 | AB (A-rated, therapeutically equivalent) | May 12, 2023 | 100MG, 300MG, 400MG |
| RISING PHARMA HOLDINGS INC | 217995 | AB1 (A-rated, therapeutically equivalent) | July 19, 2023 | 600MG, 800MG |
| ANNORA PHARMA PRIVATE LTD | 217682 | AA (A-rated, therapeutically equivalent) | January 17, 2024 | 250MG/5ML |
| ZYDUS PHARMACEUTICALS USA INC | 203934 | AB2 (A-rated, therapeutically equivalent) | January 24, 2024 | 600MG |
| ANNORA PHARMA PRIVATE LTD | 218075 | AB2 (A-rated, therapeutically equivalent) | February 26, 2024 | 600MG |
| EPIC PHARMA LLC | 216252 | AB2 (A-rated, therapeutically equivalent) | February 26, 2024 | 600MG |
| STRIDES PHARMA GLOBAL PTE LTD | 211313 | AB1 (A-rated, therapeutically equivalent) | March 4, 2024 | 600MG, 800MG |
| PHARMOBEDIENT CONSULTING LLC | 217965 | AB1 (A-rated, therapeutically equivalent) | April 8, 2024 | 600MG, 800MG |
| ABON PHARMACEUTICALS LLC | 203643 | AB2 (A-rated, therapeutically equivalent) | September 9, 2024 | 600MG |
| PHARMAZONE | 219319 | AB (A-rated, therapeutically equivalent) | August 7, 2025 | 100MG, 300MG, 400MG |
| SCIEGEN PHARMACEUTICALS INC | 218491 | AB2 (A-rated, therapeutically equivalent) | September 19, 2025 | 600MG |
| PRINSTON PHARMACEUTICAL INC | 219814 | AB (A-rated, therapeutically equivalent) | March 6, 2026 | 100MG, 300MG, 400MG |
| ACTAVIS ELIZABETH LLC | 203611 | AB2 (A-rated, therapeutically equivalent) | June 23, 2026 | 600MG |
Neurontin NDC codes
Questions
Is there a generic for Neurontin?
Yes. The generic name for Neurontin is gabapentin. 26 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AB1, AB2.
What is the generic name for Neurontin?
The active ingredient in Neurontin is gabapentin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Neurontin and Gabapentin
- What is Neurontin used for?FDA label uses
- Is Neurontin a controlled substance?Federal schedule
- What is Gabapentin used for?FDA label uses
- Is Gabapentin a controlled substance?Federal schedule
- Generic for GraliseFDA Orange Book
- Neurontin Medicare Part D coverageBy plan and state
- NDC 0071-0805Neurontin NDC record
- NDC 0071-2012Neurontin NDC record
- NDC 58151-281Neurontin NDC record