FDA Orange Book
Generic for Propecia
Propecia contains finasteride. 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 Propecia is finasteride. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Propecia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Marketed (Rx) | AB | 6 | AB |
NDA 020788, held by ORGANON LLC A SUB OF ORGANON AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic finasteride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES INC | 076436 | AB (A-rated, therapeutically equivalent) | July 28, 2006 | 1MG |
| HETERO LABS LTD UNIT III | 090060 | AB (A-rated, therapeutically equivalent) | July 1, 2013 | 1MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090508 | AB (A-rated, therapeutically equivalent) | July 1, 2013 | 1MG |
| ACCORD HEALTHCARE INC | 091643 | AB (A-rated, therapeutically equivalent) | November 5, 2013 | 1MG |
| AUROBINDO PHARMA LTD | 203687 | AB (A-rated, therapeutically equivalent) | November 5, 2013 | 1MG |
| ALKEM LABORATORIES LTD | 207750 | AB (A-rated, therapeutically equivalent) | January 6, 2017 | 1MG |
Propecia NDC codes
Questions
Is there a generic for Propecia?
Yes. The generic name for Propecia is finasteride. 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 Propecia?
The active ingredient in Propecia is finasteride, 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.