FDA Orange Book
Generic for Sabril
Sabril contains vigabatrin. 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 Sabril is vigabatrin. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Sabril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 500MG/PACKET | Marketed (Rx) | AA | 10 | AA |
| tablet, oral | 500MG | Marketed (Rx) | AB | 8 | AB |
NDA 022006, 020427, held by LUNDBECK PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic vigabatrin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 208218 | AA (A-rated, therapeutically equivalent) | April 27, 2017 | 500MG/PACKET |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 210155 | AA (A-rated, therapeutically equivalent) | March 13, 2018 | 500MG/PACKET |
| BORA PHARMACEUTICAL HOLDINGS LLC | 210196 | AA (A-rated, therapeutically equivalent) | June 21, 2018 | 500MG/PACKET |
| DR REDDYS LABORATORIES LTD | 211481 | AA (A-rated, therapeutically equivalent) | November 20, 2018 | 500MG/PACKET |
| TEVA PHARMACEUTICALS USA | 209822 | AB (A-rated, therapeutically equivalent) | January 14, 2019 | 500MG |
| INVAGEN PHARMACEUTICALS INC | 211592 | AA (A-rated, therapeutically equivalent) | December 3, 2019 | 500MG/PACKET |
| ALKEM LABORATORIES LTD | 213375 | AA (A-rated, therapeutically equivalent) | December 2, 2020 | 500MG/PACKET |
| ANNORA PHARMA PRIVATE LTD | 213519 | AA (A-rated, therapeutically equivalent) | January 26, 2021 | 500MG/PACKET |
| DR REDDYS LABORATORIES LTD | 211539 | AB (A-rated, therapeutically equivalent) | January 29, 2021 | 500MG |
| DEXCEL PHARMA TECHNOLOGIES LTD | 215109 | AB (A-rated, therapeutically equivalent) | September 23, 2021 | 500MG |
| AUROBINDO PHARMA LTD | 213899 | AA (A-rated, therapeutically equivalent) | September 29, 2021 | 500MG/PACKET |
| ZYDUS LIFESCIENCES GLOBAL FZE | 215707 | AB (A-rated, therapeutically equivalent) | January 19, 2022 | 500MG |
| AUROBINDO PHARMA LTD | 215601 | AB (A-rated, therapeutically equivalent) | May 10, 2022 | 500MG |
| PYROS PHARMACEUTICALS INC | 214961 | AA (A-rated, therapeutically equivalent) | June 24, 2022 | 500MG/PACKET |
| HIKMA PHARMACEUTICALS USA INC | 213104 | AB (A-rated, therapeutically equivalent) | August 29, 2022 | 500MG |
| MSN LABORATORIES PRIVATE LTD | 215363 | AA (A-rated, therapeutically equivalent) | September 7, 2022 | 500MG/PACKET |
| CARNEGIE PHARMACEUTICALS LLC | 215519 | AB (A-rated, therapeutically equivalent) | April 28, 2023 | 500MG |
| UPSHER SMITH LABORATORIES LLC | 214749 | AB (A-rated, therapeutically equivalent) | June 29, 2023 | 500MG |
Sabril NDC codes
Questions
Is there a generic for Sabril?
Yes. The generic name for Sabril is vigabatrin. 16 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
What is the generic name for Sabril?
The active ingredient in Sabril is vigabatrin, 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.