FDA Orange Book
Generic for Danocrine
Danocrine contains danazol. 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 Danocrine is danazol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Danocrine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 2 | AB |
| capsule, oral | 200MG | Discontinued | None | 2 | AB |
| capsule, oral | 50MG | Discontinued | None | 2 | AB |
NDA 017557, 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 danazol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 074582 | AB (A-rated, therapeutically equivalent) | May 29, 1998 | 100MG, 200MG, 50MG |
| LANNETT CO INC | 077246 | AB (A-rated, therapeutically equivalent) | April 19, 2007 | 100MG, 200MG, 50MG |
Questions
Is there a generic for Danocrine?
Yes. The generic name for Danocrine is danazol. 2 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 Danocrine?
The active ingredient in Danocrine is danazol, 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.