Generic for EstroGel: Estradiol

Yes. The generic name for EstroGel is estradiol. 3 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 EstroGel products the Orange Book lists.

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EstroGel products in the Orange Book

EstroGel products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, metered, transdermal	0.06% (1.25GM/ACTIVATION)	Marketed (Rx)	AB	3	AB
gel, topical	0.06%	Discontinued	None	0	None

NDA 021166, held by ASCEND THERAPEUTICS US LLC. 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 EstroGel
Company	ANDA	TE code	Approved	Strengths
SOLARIS PHARMA CORP	216160	AB (A-rated, therapeutically equivalent)	April 22, 2024	0.06% (1.25GM/ACTIVATION)
NOVITIUM PHARMA LLC	217882	AB (A-rated, therapeutically equivalent)	October 23, 2024	0.06% (1.25GM/ACTIVATION)
ENCUBE ETHICALS PRIVATE LTD	218214	AB (A-rated, therapeutically equivalent)	May 11, 2026	0.06% (1.25GM/ACTIVATION)

EstroGel NDC codes

17139-617

Questions

Is there a generic for EstroGel?

Yes. The generic name for EstroGel is estradiol. 3 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 EstroGel products the Orange Book lists.

What is the generic name for EstroGel?

The active ingredient in EstroGel 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 EstroGel