Generic for Vagifem: Estradiol

Yes. The generic name for Vagifem is estradiol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Vagifem products the Orange Book lists.

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Vagifem products in the Orange Book

Vagifem products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, vaginal	10MCG	Marketed (Rx)	AB	4	AB
tablet, vaginal	25MCG	Discontinued	None	0	None

NDA 020908, held by NOVO NORDISK 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 Vagifem
Company	ANDA	TE code	Approved	Strengths
AMNEAL PHARMACEUTICALS	205256	AB (A-rated, therapeutically equivalent)	May 29, 2015	10MCG
TEVA PHARMACEUTICALS USA	206388	AB (A-rated, therapeutically equivalent)	July 21, 2017	10MCG
GLENMARK PHARMACEUTICALS LTD	210264	AB (A-rated, therapeutically equivalent)	September 14, 2018	10MCG
AUROBINDO PHARMA LTD	216550	AB (A-rated, therapeutically equivalent)	August 2, 2024	10MCG

Vagifem NDC codes

0169-5176

Questions

Is there a generic for Vagifem?

Yes. The generic name for Vagifem is estradiol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Vagifem products the Orange Book lists.

What is the generic name for Vagifem?

The active ingredient in Vagifem 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.

Generic for Vagifem