FDA Orange Book
Generic for Dostinex
Dostinex contains cabergoline. 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 Dostinex is cabergoline. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Dostinex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.5MG | Discontinued | None | 6 | AB |
NDA 020664, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cabergoline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA INTERNATIONAL AG | 076310 | AB (A-rated, therapeutically equivalent) | December 29, 2005 | 0.5MG |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 077750 | AB (A-rated, therapeutically equivalent) | March 7, 2007 | 0.5MG |
| INGENUS PHARMACEUTICALS LLC | 204735 | AB (A-rated, therapeutically equivalent) | August 1, 2018 | 0.5MG |
| AMNEAL PHARMACEUTICALS LLC | 218618 | AB (A-rated, therapeutically equivalent) | June 26, 2024 | 0.5MG |
| SOMERSET THERAPEUTICS LLC | 218109 | AB (A-rated, therapeutically equivalent) | September 9, 2024 | 0.5MG |
| RENATA PLC | 220309 | AB (A-rated, therapeutically equivalent) | June 15, 2026 | 0.5MG |
Dostinex NDC codes
Questions
Is there a generic for Dostinex?
Yes. The generic name for Dostinex is cabergoline. 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 Dostinex?
The active ingredient in Dostinex is cabergoline, 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.