FDA Orange Book
Generic for Plavix
Plavix contains clopidogrel. 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 Plavix is clopidogrel. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Plavix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 300MG BASE | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | EQ 75MG BASE | Marketed (Rx) | AB | 16 | AB |
NDA 020839, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clopidogrel
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 076273 | AB (A-rated, therapeutically equivalent) | January 14, 2008 | EQ 75MG BASE |
| DR REDDYS LABORATORIES LTD | 091023 | AB (A-rated, therapeutically equivalent) | May 17, 2012 | EQ 300MG BASE, EQ 75MG BASE |
| AUROBINDO PHARMA LTD | 090540 | AB (A-rated, therapeutically equivalent) | May 17, 2012 | EQ 75MG BASE |
| PHARMAZONE | 078004 | AB (A-rated, therapeutically equivalent) | May 17, 2012 | EQ 75MG BASE |
| TEVA PHARMACEUTICALS USA INC | 076999 | AB (A-rated, therapeutically equivalent) | May 17, 2012 | EQ 75MG BASE |
| TORRENT PHARMACEUTICALS LTD | 090844 | AB (A-rated, therapeutically equivalent) | May 17, 2012 | EQ 75MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 202928 | AB (A-rated, therapeutically equivalent) | February 10, 2014 | EQ 75MG BASE |
| APOTEX INC | 076274 | AB (A-rated, therapeutically equivalent) | March 4, 2014 | EQ 300MG BASE, EQ 75MG BASE |
| AMNEAL PHARMACEUTICALS | 203751 | AB (A-rated, therapeutically equivalent) | April 11, 2014 | EQ 75MG BASE |
| SCIEGEN PHARMACEUTICALS INC | 204165 | AB (A-rated, therapeutically equivalent) | September 15, 2014 | EQ 300MG BASE, EQ 75MG BASE |
| RISING PHARMA HOLDINGS INC | 204359 | AB (A-rated, therapeutically equivalent) | February 2, 2017 | EQ 75MG BASE |
| PRINSTON PHARMACEUTICAL INC | 206376 | AB (A-rated, therapeutically equivalent) | May 7, 2018 | EQ 300MG BASE, EQ 75MG BASE |
| PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 213351 | AB (A-rated, therapeutically equivalent) | July 17, 2020 | EQ 300MG BASE, EQ 75MG BASE |
| HETERO LABS LTD UNIT V | 205345 | AB (A-rated, therapeutically equivalent) | August 4, 2023 | EQ 300MG BASE, EQ 75MG BASE |
| ALKEM LABORATORIES LTD | 203632 | AB (A-rated, therapeutically equivalent) | December 8, 2023 | EQ 75MG BASE |
| MSN LABORATORIES PRIVATE LTD | 215388 | AB (A-rated, therapeutically equivalent) | September 20, 2024 | EQ 75MG BASE |
Plavix NDC codes
Questions
Is there a generic for Plavix?
Yes. The generic name for Plavix is clopidogrel. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Plavix?
The active ingredient in Plavix is clopidogrel, 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.