FDA Orange Book
Generic for Lyrica
Lyrica contains pregabalin. 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 Lyrica is pregabalin. 22 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.
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Lyrica products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 22 | AB |
| capsule, oral | 150MG | Marketed (Rx) | AB | 22 | AB |
| capsule, oral | 200MG | Marketed (Rx) | AB | 21 | AB |
| capsule, oral | 225MG | Marketed (Rx) | AB | 20 | AB |
| capsule, oral | 25MG | Marketed (Rx) | AB | 20 | AB |
| capsule, oral | 300MG | Marketed (Rx) | AB | 22 | AB |
| capsule, oral | 50MG | Marketed (Rx) | AB | 22 | AB |
| capsule, oral | 75MG | Marketed (Rx) | AB | 23 | AB |
| solution, oral | 20MG/ML | Marketed (Rx) | AA | 2 | AA |
NDA 021446, 022488, held by UPJOHN US 2 LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pregabalin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 203459 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| ALKEM LABORATORIES LTD | 207799 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 209743 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| DR REDDYS LABORATORIES LTD | 209664 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| INVAGEN PHARMACEUTICALS INC | 211384 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| MSN LABORATORIES PRIVATE LTD | 209357 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| RISING PHARMA HOLDINGS INC | 210432 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| SCIEGEN PHARMACEUTICALS INC | 208677 | AB (A-rated, therapeutically equivalent) | July 19, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| ALKEM LABORATORIES LTD | 207623 | AA (A-rated, therapeutically equivalent) | July 19, 2019 | 20MG/ML |
| PHARMOBEDIENT CONSULTING LLC | 210891 | AB (A-rated, therapeutically equivalent) | September 30, 2019 | 300MG, 75MG |
| HETERO LABS LTD UNIT III | 206912 | AB (A-rated, therapeutically equivalent) | October 8, 2019 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| SOMERSET THERAPEUTICS LLC | 210585 | AB (A-rated, therapeutically equivalent) | December 26, 2019 | 100MG, 150MG, 200MG, 300MG, 50MG, 75MG |
| CHARTWELL RX SCIENCES LLC | 212865 | AB (A-rated, therapeutically equivalent) | March 20, 2020 | 100MG, 150MG, 50MG, 75MG |
| CREEKWOOD PHARMACEUTICALS LLC | 213423 | AB (A-rated, therapeutically equivalent) | March 23, 2020 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| TRIS PHARMA INC | 214322 | AB (A-rated, therapeutically equivalent) | July 15, 2021 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| ANDA REPOSITORY LLC | 212604 | AA (A-rated, therapeutically equivalent) | February 18, 2022 | 20MG/ML |
| PHARMAZONE | 212988 | AB (A-rated, therapeutically equivalent) | March 8, 2022 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| PHARMAZONE | 216197 | AB (A-rated, therapeutically equivalent) | July 18, 2022 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| PRINSTON PHARMACEUTICAL INC | 207883 | AB (A-rated, therapeutically equivalent) | September 1, 2022 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| AUROBINDO PHARMA LTD | 205321 | AB (A-rated, therapeutically equivalent) | March 29, 2023 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| REGCON HOLDINGS LLC | 208113 | AB (A-rated, therapeutically equivalent) | May 17, 2024 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| PHARMOBEDIENT CONSULTING LLC | 091222 | AB (A-rated, therapeutically equivalent) | February 21, 2025 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| TORRENT PHARMACEUTICALS LTD | 206942 | AB (A-rated, therapeutically equivalent) | February 21, 2025 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| JUBILANT GENERICS LTD | 209530 | AB (A-rated, therapeutically equivalent) | May 20, 2025 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
| CAPLIN STERILES LTD | 218529 | AB (A-rated, therapeutically equivalent) | February 24, 2026 | 100MG, 150MG, 200MG, 225MG, 25MG, 300MG, 50MG, 75MG |
Lyrica NDC codes
Questions
Is there a generic for Lyrica?
Yes. The generic name for Lyrica is pregabalin. 22 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 Lyrica?
The active ingredient in Lyrica is pregabalin, 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 Lyrica and Pregabalin
- What is Lyrica used for?FDA label uses
- Is Lyrica a controlled substance?Schedule V
- What is Pregabalin used for?FDA label uses
- Is Pregabalin a controlled substance?Schedule V
- Generic for Lyrica CRFDA Orange Book
- Lyrica Medicare Part D coverageBy plan and state
- NDC 0071-1018Lyrica NDC record
- NDC 58151-236Lyrica NDC record
- NDC 58151-237Lyrica NDC record
- Schedule V drugs listDEA schedule