FDA Orange Book
Generic for Imuran
Imuran contains azathioprine. 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 Imuran is azathioprine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Imuran products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 100MG BASE/VIAL | Discontinued | None | 1 | None |
| tablet, oral | 25MG | Discontinued | None | 3 | AB |
| tablet, oral | 50MG | Marketed (Rx) | AB | 5 | AB |
NDA 017391, 016324, held by CASPER PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic azathioprine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 074419 | None (No TE code listed) | March 31, 1995 | EQ 100MG BASE/VIAL |
| AMNEAL PHARMACEUTICALS LLC | 074069 | AB (A-rated, therapeutically equivalent) | February 16, 1996 | 50MG |
| RISING PHARMA HOLDINGS INC | 075568 | AB (A-rated, therapeutically equivalent) | December 13, 1999 | 50MG |
| AAIPHARMA LLC | 075252 | AB (A-rated, therapeutically equivalent) | February 3, 2003 | 25MG, 50MG |
| ZYDUS PHARMACEUTICALS USA INC | 077621 | AB (A-rated, therapeutically equivalent) | September 5, 2008 | 25MG, 50MG |
| ALKEM LABORATORIES LTD | 208687 | AB (A-rated, therapeutically equivalent) | March 27, 2020 | 25MG, 50MG |
Imuran NDC codes
Questions
Is there a generic for Imuran?
Yes. The generic name for Imuran is azathioprine. 6 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 Imuran?
The active ingredient in Imuran is azathioprine, 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.