FDA Orange Book
Is there a generic for Prempro?
Prempro contains medroxyprogesterone acetate and estrogens conjugated. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Prempro (medroxyprogesterone acetate and estrogens conjugated).
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Prempro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.3MG;1.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral-28 | 0.45MG;1.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral-28 | 0.625MG;2.5MG | Marketed (Rx) | None | 0 | None |
| tablet, oral-28 | 0.625MG;5MG | Marketed (Rx) | None | 0 | None |
NDA 020527, held by WYETH PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Prempro NDC codes
Questions
Is there a generic for Prempro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Prempro (medroxyprogesterone acetate and estrogens conjugated).
What is the generic name for Prempro?
The active ingredient in Prempro is medroxyprogesterone acetate and estrogens conjugated, 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.