FDA Orange Book

Generic for Provera

Provera contains medroxyprogesterone 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 Provera is medroxyprogesterone acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Provera products in the Orange Book

Provera products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	10MG	Marketed (Rx)	AB	1	AB
tablet, oral	2.5MG	Marketed (Rx)	AB	1	AB
tablet, oral	5MG	Marketed (Rx)	AB	1	AB

NDA 011839, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic medroxyprogesterone acetate

Approved generic versions of Provera
Company	ANDA	TE code	Approved	Strengths
BARR LABORATORIES INC	040159	AB (A-rated, therapeutically equivalent)	August 9, 1996	10MG, 2.5MG, 5MG

Provera NDC codes

Questions

Is there a generic for Provera?

Yes. The generic name for Provera is medroxyprogesterone acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Provera?

The active ingredient in Provera is medroxyprogesterone 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.