FDA Orange Book
Generic for Coumadin
Coumadin contains warfarin. 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 Coumadin is warfarin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 9 of the 12 Coumadin products the Orange Book lists.
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Coumadin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 50MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 5MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 75MG/VIAL | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 6 | AB |
| tablet, oral | 1MG | Discontinued | None | 6 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 6 | AB |
| tablet, oral | 2MG | Discontinued | None | 6 | AB |
| tablet, oral | 3MG | Discontinued | None | 6 | AB |
| tablet, oral | 4MG | Discontinued | None | 6 | AB |
| tablet, oral | 5MG | Discontinued | None | 6 | AB |
| tablet, oral | 6MG | Discontinued | None | 6 | AB |
| tablet, oral | 7.5MG | Discontinued | None | 6 | AB |
NDA 009218, held by BRISTOL MYERS SQUIBB PHARMA CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic warfarin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 040301 | AB (A-rated, therapeutically equivalent) | July 15, 1999 | 10MG, 1MG, 2.5MG, 2MG, 3MG, 4MG, 5MG, 6MG, 7.5MG |
| UPSHER SMITH LABORATORIES LLC | 040416 | AB (A-rated, therapeutically equivalent) | October 2, 2003 | 10MG, 1MG, 2.5MG, 2MG, 3MG, 4MG, 5MG, 6MG, 7.5MG |
| ZYDUS PHARMACEUTICALS USA INC | 040663 | AB (A-rated, therapeutically equivalent) | May 30, 2006 | 10MG, 1MG, 2.5MG, 2MG, 3MG, 4MG, 5MG, 6MG, 7.5MG |
| PLIVA INC | 040616 | AB (A-rated, therapeutically equivalent) | July 5, 2006 | 10MG, 1MG, 2.5MG, 2MG, 3MG, 4MG, 5MG, 6MG, 7.5MG |
| INVAGEN PHARMACEUTICALS INC | 090935 | AB (A-rated, therapeutically equivalent) | May 25, 2011 | 10MG, 1MG, 2.5MG, 2MG, 3MG, 4MG, 5MG, 6MG, 7.5MG |
| AMNEAL PHARMACEUTICALS | 202202 | AB (A-rated, therapeutically equivalent) | March 4, 2013 | 10MG, 1MG, 2.5MG, 2MG, 3MG, 4MG, 5MG, 6MG, 7.5MG |
Questions
Is there a generic for Coumadin?
Yes. The generic name for Coumadin is warfarin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 9 of the 12 Coumadin products the Orange Book lists.
What is the generic name for Coumadin?
The active ingredient in Coumadin is warfarin, 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.