FDA Orange Book
Generic for Clomid
Clomid contains clomiphene. 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 Clomid is clomiphene. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Clomid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 50MG | Discontinued | None | 7 | AB |
NDA 016131, 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 clomiphene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GRANATA BIO CORP | 072196 | AB (A-rated, therapeutically equivalent) | December 20, 1988 | 50MG |
| COSETTE PHARMACEUTICALS INC | 075528 | AB (A-rated, therapeutically equivalent) | August 30, 1999 | 50MG |
| APPCO PHARMA LLC | 216739 | AB (A-rated, therapeutically equivalent) | November 8, 2024 | 50MG |
| RUBICON RESEARCH LTD | 216545 | AB (A-rated, therapeutically equivalent) | November 12, 2024 | 50MG |
| ACCORD HEALTHCARE INC | 219406 | AB (A-rated, therapeutically equivalent) | October 3, 2025 | 50MG |
| NOVITIUM PHARMA LLC | 219781 | AB (A-rated, therapeutically equivalent) | October 17, 2025 | 50MG |
| ASCENT PHARMACEUTICALS INC | 220673 | AB (A-rated, therapeutically equivalent) | May 15, 2026 | 50MG |
Questions
Is there a generic for Clomid?
Yes. The generic name for Clomid is clomiphene. 7 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 Clomid?
The active ingredient in Clomid is clomiphene, 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.