FDA Orange Book

Generic for Testim

Testim contains testosterone. 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 Testim is testosterone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.

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Testim products in the Orange Book

Testim products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
gel, transdermal	50MG/5GM PACKET	Marketed (Rx)	AB2	4	AB1, AB2

NDA 021454, held by ENDO OPERATIONS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic testosterone

Approved generic versions of Testim
Company	ANDA	TE code	Approved	Strengths
ACTAVIS LABORATORIES UT INC	076737	AB1 (A-rated, therapeutically equivalent)	January 27, 2006	50MG/5GM PACKET
STRIDES PHARMA INTERNATIONAL AG	076744	AB1 (A-rated, therapeutically equivalent)	May 23, 2007	50MG/5GM PACKET
ACTAVIS LABORATORIES UT INC	091073	AB2 (A-rated, therapeutically equivalent)	September 18, 2017	50MG/5GM PACKET
ENCUBE ETHICALS PRIVATE LTD	212984	AB1 (A-rated, therapeutically equivalent)	November 9, 2021	50MG/5GM PACKET

Testim NDC codes

66887-001

Questions

Is there a generic for Testim?

Yes. The generic name for Testim is testosterone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.

What is the generic name for Testim?

The active ingredient in Testim is testosterone, 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.