FDA Orange Book
Generic for Gralise
Gralise 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 Gralise is gabapentin. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2.
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Gralise products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 300MG | Marketed (Rx) | AB2 | 6 | AB2 |
| tablet, oral | 450MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 600MG | Marketed (Rx) | AB2 | 19 | AB1, AB2 |
| tablet, oral | 750MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 900MG | Marketed (Rx) | AB | 1 | AB |
NDA 022544, held by ALMATICA PHARMA INC. 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 |
|---|---|---|---|---|
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 076017 | None (No TE code listed) | April 28, 2004 | 300MG |
| GLENMARK PHARMACEUTICALS LTD | 077662 | AB1 (A-rated, therapeutically equivalent) | August 18, 2006 | 600MG |
| RUBICON RESEARCH LTD | 077661 | AB1 (A-rated, therapeutically equivalent) | September 13, 2006 | 600MG |
| ZYDUS PHARMACEUTICALS USA INC | 078926 | AB1 (A-rated, therapeutically equivalent) | February 11, 2011 | 600MG |
| AUROBINDO PHARMA LTD | 200651 | AB1 (A-rated, therapeutically equivalent) | October 6, 2011 | 600MG |
| STRIDES PHARMA GLOBAL PTE LTD | 203244 | AB1 (A-rated, therapeutically equivalent) | July 12, 2013 | 600MG |
| ALKEM LABORATORIES LTD | 206402 | AB1 (A-rated, therapeutically equivalent) | December 23, 2015 | 600MG |
| SCIEGEN PHARMACEUTICALS INC | 205101 | AB1 (A-rated, therapeutically equivalent) | February 4, 2016 | 600MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 207057 | AB1 (A-rated, therapeutically equivalent) | October 26, 2017 | 600MG |
| ASCENT PHARMACEUTICALS INC | 214957 | AB1 (A-rated, therapeutically equivalent) | October 1, 2021 | 600MG |
| GRANULES INDIA LTD | 217116 | AB1 (A-rated, therapeutically equivalent) | March 28, 2023 | 600MG |
| RISING PHARMA HOLDINGS INC | 217995 | AB1 (A-rated, therapeutically equivalent) | July 19, 2023 | 600MG |
| ZYDUS PHARMACEUTICALS USA INC | 203934 | AB2 (A-rated, therapeutically equivalent) | January 24, 2024 | 300MG, 450MG, 600MG, 750MG, 900MG |
| ANNORA PHARMA PRIVATE LTD | 218075 | AB2 (A-rated, therapeutically equivalent) | February 26, 2024 | 300MG, 600MG |
| EPIC PHARMA LLC | 216252 | AB2 (A-rated, therapeutically equivalent) | February 26, 2024 | 300MG, 600MG |
| STRIDES PHARMA GLOBAL PTE LTD | 211313 | AB1 (A-rated, therapeutically equivalent) | March 4, 2024 | 600MG |
| PHARMOBEDIENT CONSULTING LLC | 217965 | AB1 (A-rated, therapeutically equivalent) | April 8, 2024 | 600MG |
| ABON PHARMACEUTICALS LLC | 203643 | AB2 (A-rated, therapeutically equivalent) | September 9, 2024 | 600MG |
| SCIEGEN PHARMACEUTICALS INC | 218491 | AB2 (A-rated, therapeutically equivalent) | September 19, 2025 | 300MG, 600MG |
| ACTAVIS ELIZABETH LLC | 203611 | AB2 (A-rated, therapeutically equivalent) | June 23, 2026 | 300MG, 600MG |
Gralise NDC codes
Questions
Is there a generic for Gralise?
Yes. The generic name for Gralise is gabapentin. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AB1, AB2.
What is the generic name for Gralise?
The active ingredient in Gralise 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 Gralise and Gabapentin
- What is Gralise used for?FDA label uses
- Is Gralise a controlled substance?Federal schedule
- What is Gabapentin used for?FDA label uses
- Is Gabapentin a controlled substance?Federal schedule
- Generic for NeurontinFDA Orange Book
- Gralise Medicare Part D coverageBy plan and state
- NDC 52427-803Gralise NDC record
- NDC 52427-804Gralise NDC record
- NDC 52427-806Gralise NDC record