FDA Orange Book

Generic for Endometrin

Endometrin 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 Endometrin is progesterone. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Endometrin products in the Orange Book

Endometrin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
insert, vaginal100MGMarketed (Rx)AB2AB

NDA 022057, held by FERRING PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic progesterone

Approved generic versions of Endometrin
CompanyANDATE codeApprovedStrengths
XIROMED PHARMA ESPANA SL218391AB (A-rated, therapeutically equivalent)September 19, 2025100MG
GLENMARK PHARMACEUTICALS INC USA216363AB (A-rated, therapeutically equivalent)April 8, 2026100MG

Endometrin NDC codes

Questions

Is there a generic for Endometrin?

Yes. The generic name for Endometrin is progesterone. 2 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 Endometrin?

The active ingredient in Endometrin 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.

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