FDA Orange Book
Generic for Premarin
Premarin contains 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
Yes. The generic name for Premarin is estrogens conjugated. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 8 Premarin products the Orange Book lists.
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Premarin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical, vaginal | 0.625MG/GM | Marketed (Rx) | None | 0 | None |
| injectable, injection | 25MG/VIAL | Marketed (Rx) | None | 0 | None |
| tablet, oral | 0.3MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 0.45MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 0.625MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 0.9MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 1.25MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 2.5MG | Discontinued | None | 0 | None |
NDA 020216, 010402, 004782, 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.
Approved generic estrogens conjugated
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVAST LABORATORIES LTD | 214025 | AB (A-rated, therapeutically equivalent) | October 15, 2025 | 0.3MG, 0.45MG, 0.625MG |
| NOVAST LABORATORIES LTD | 214023 | AB (A-rated, therapeutically equivalent) | October 15, 2025 | 0.9MG, 1.25MG |
Premarin NDC codes
Questions
Is there a generic for Premarin?
Yes. The generic name for Premarin is estrogens conjugated. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 8 Premarin products the Orange Book lists.
What is the generic name for Premarin?
The active ingredient in Premarin is 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.