FDA Orange Book
Generic for Athrombin
Athrombin 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 Athrombin is warfarin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Athrombin products the Orange Book lists.
Run it in Rivvi
Map Athrombin and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Athrombin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 6 | AB |
| tablet, oral | 25MG | Discontinued | None | 0 | None |
| tablet, oral | 5MG | Discontinued | None | 6 | AB |
NDA 011771, held by PHARMACEUTICAL RESEARCH ASSOC INC. 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, 5MG |
| UPSHER SMITH LABORATORIES LLC | 040416 | AB (A-rated, therapeutically equivalent) | October 2, 2003 | 10MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 040663 | AB (A-rated, therapeutically equivalent) | May 30, 2006 | 10MG, 5MG |
| PLIVA INC | 040616 | AB (A-rated, therapeutically equivalent) | July 5, 2006 | 10MG, 5MG |
| INVAGEN PHARMACEUTICALS INC | 090935 | AB (A-rated, therapeutically equivalent) | May 25, 2011 | 10MG, 5MG |
| AMNEAL PHARMACEUTICALS | 202202 | AB (A-rated, therapeutically equivalent) | March 4, 2013 | 10MG, 5MG |
Questions
Is there a generic for Athrombin?
Yes. The generic name for Athrombin is warfarin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Athrombin products the Orange Book lists.
What is the generic name for Athrombin?
The active ingredient in Athrombin 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.