FDA Orange Book

Generic for Menostar

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

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Menostar products in the Orange Book

Menostar products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
system, transdermal	0.014MG/24HR	Marketed (Rx)	AB	1	AB

NDA 021674, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic estradiol

Approved generic versions of Menostar
Company	ANDA	TE code	Approved	Strengths
ZYDUS PHARMACEUTICALS USA INC	204379	AB (A-rated, therapeutically equivalent)	April 17, 2023	0.014MG/24HR

Questions

Is there a generic for Menostar?

Yes. The generic name for Menostar is estradiol. 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 Menostar?

The active ingredient in Menostar is estradiol, 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.