FDA Orange Book
Generic for Megace
Megace contains megestrol acetate. 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 Megace is megestrol acetate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Megace products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 40MG/ML | Discontinued | None | 3 | AB |
| tablet, oral | 20MG | Discontinued | None | 2 | AB |
| tablet, oral | 40MG | Discontinued | None | 2 | AB |
NDA 020264, 016979, held by BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic megestrol acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| STRIDES PHARMA INTERNATIONAL AG | 072422 | AB (A-rated, therapeutically equivalent) | August 8, 1988 | 20MG |
| STRIDES PHARMA INTERNATIONAL AG | 072423 | AB (A-rated, therapeutically equivalent) | August 8, 1988 | 40MG |
| BARR LABORATORIES INC | 074621 | AB (A-rated, therapeutically equivalent) | August 16, 1996 | 20MG, 40MG |
| STRIDES PHARMA INTERNATIONAL AG | 075671 | AB (A-rated, therapeutically equivalent) | July 25, 2001 | 40MG/ML |
| PHARMOBEDIENT CONSULTING LLC | 076721 | AB (A-rated, therapeutically equivalent) | November 1, 2004 | 40MG/ML |
| NOVITIUM PHARMA LLC | 077404 | AB (A-rated, therapeutically equivalent) | February 16, 2006 | 40MG/ML |
Questions
Is there a generic for Megace?
Yes. The generic name for Megace is megestrol acetate. 4 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 Megace?
The active ingredient in Megace is megestrol acetate, 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.