FDA Orange Book

Generic for Divigel

Divigel 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 Divigel is estradiol. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Divigel products in the Orange Book

Divigel products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, transdermal	0.1% (0.25GM/PACKET)	Marketed (Rx)	AB	6	AB
gel, transdermal	0.1% (0.5GM/PACKET)	Marketed (Rx)	AB	6	AB
gel, transdermal	0.1% (0.75GM/PACKET)	Marketed (Rx)	AB	5	AB
gel, transdermal	0.1% (1.25GM/PACKET)	Marketed (Rx)	AB	5	AB
gel, transdermal	0.1% (1GM/PACKET)	Marketed (Rx)	AB	6	AB

NDA 022038, held by VERTICAL PHARMACEUTICALS 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 Divigel
Company	ANDA	TE code	Approved	Strengths
XIROMED PHARMA ESPANA SL	211783	AB (A-rated, therapeutically equivalent)	August 10, 2022	0.1% (0.25GM/PACKET), 0.1% (0.5GM/PACKET), 0.1% (1GM/PACKET)
NOVITIUM PHARMA LLC	217610	AB (A-rated, therapeutically equivalent)	August 24, 2023	0.1% (0.25GM/PACKET), 0.1% (0.5GM/PACKET), 0.1% (0.75GM/PACKET), 0.1% (1.25GM/PACKET), 0.1% (1GM/PACKET)
PADAGIS ISRAEL PHARMACEUTICALS LTD	216524	AB (A-rated, therapeutically equivalent)	November 14, 2023	0.1% (0.25GM/PACKET), 0.1% (0.5GM/PACKET), 0.1% (0.75GM/PACKET), 0.1% (1.25GM/PACKET), 0.1% (1GM/PACKET)
AMNEAL PHARMACEUTICALS LLC	216055	AB (A-rated, therapeutically equivalent)	July 12, 2024	0.1% (0.25GM/PACKET), 0.1% (0.5GM/PACKET), 0.1% (0.75GM/PACKET), 0.1% (1.25GM/PACKET), 0.1% (1GM/PACKET)
AMVIKA PHARMA LLC	217863	AB (A-rated, therapeutically equivalent)	July 12, 2024	0.1% (0.25GM/PACKET), 0.1% (0.5GM/PACKET), 0.1% (0.75GM/PACKET), 0.1% (1.25GM/PACKET), 0.1% (1GM/PACKET)
ENCUBE ETHICALS PRIVATE LTD	218507	AB (A-rated, therapeutically equivalent)	March 5, 2025	0.1% (0.25GM/PACKET), 0.1% (0.5GM/PACKET), 0.1% (0.75GM/PACKET), 0.1% (1.25GM/PACKET), 0.1% (1GM/PACKET)

Divigel NDC codes

Questions

Is there a generic for Divigel?

Yes. The generic name for Divigel is estradiol. 6 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 Divigel?

The active ingredient in Divigel 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.