FDA Orange Book
Generic for Proscar
Proscar 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 Proscar is finasteride. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Proscar 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.
Proscar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 5MG | Marketed (Rx) | AB | 8 | AB |
NDA 020180, 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 076511 | AB (A-rated, therapeutically equivalent) | December 15, 2006 | 5MG |
| DR REDDYS LABORATORIES LTD | 076437 | AB (A-rated, therapeutically equivalent) | February 28, 2007 | 5MG |
| AUROBINDO PHARMA LTD | 078341 | AB (A-rated, therapeutically equivalent) | October 30, 2007 | 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 078900 | AB (A-rated, therapeutically equivalent) | December 28, 2009 | 5MG |
| ACCORD HEALTHCARE INC | 090121 | AB (A-rated, therapeutically equivalent) | February 23, 2010 | 5MG |
| HETERO LABS LTD UNIT III | 090061 | AB (A-rated, therapeutically equivalent) | June 7, 2010 | 5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090507 | AB (A-rated, therapeutically equivalent) | August 16, 2011 | 5MG |
| ALKEM LABORATORIES LTD | 204304 | AB (A-rated, therapeutically equivalent) | January 5, 2017 | 5MG |
Proscar NDC codes
Questions
Is there a generic for Proscar?
Yes. The generic name for Proscar is finasteride. 8 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 Proscar?
The active ingredient in Proscar 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.