FDA Orange Book
Generic for Prometrium
Prometrium contains progesterone. 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 Prometrium is progesterone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Prometrium products the Orange Book lists.
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Prometrium products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 6 | AB |
| capsule, oral | 200MG | Marketed (Rx) | AB | 6 | AB |
| capsule, oral | 300MG | Discontinued | None | 0 | None |
NDA 019781, held by ACERTIS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic progesterone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SOFGEN PHARMACEUTICALS LLC | 200456 | AB (A-rated, therapeutically equivalent) | September 28, 2012 | 100MG, 200MG |
| BIONPHARMA INC | 200900 | AB (A-rated, therapeutically equivalent) | August 16, 2013 | 100MG, 200MG |
| DR REDDYS LABORATORIES INC | 208801 | AB (A-rated, therapeutically equivalent) | February 28, 2017 | 100MG, 200MG |
| AMNEAL PHARMACEUTICALS OF NY LLC | 207724 | AB (A-rated, therapeutically equivalent) | September 7, 2017 | 100MG, 200MG |
| XIROMED PHARMA ESPANA SL | 205229 | AB (A-rated, therapeutically equivalent) | October 20, 2017 | 100MG, 200MG |
| EUGIA PHARMA SPECIALITIES LTD | 211285 | AB (A-rated, therapeutically equivalent) | October 26, 2018 | 100MG, 200MG |
Prometrium NDC codes
Questions
Is there a generic for Prometrium?
Yes. The generic name for Prometrium is progesterone. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Prometrium products the Orange Book lists.
What is the generic name for Prometrium?
The active ingredient in Prometrium is progesterone, 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.