FDA Orange Book

Generic for Epipen

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

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Epipen products in the Orange Book

Epipen products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
injectable, intramuscular, subcutaneous	0.3MG/DELIVERY	Marketed (Rx)	AB	1	AB

NDA 019430, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic epinephrine

Approved generic versions of Epipen
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	090589	AB (A-rated, therapeutically equivalent)	August 16, 2018	0.3MG/DELIVERY

Epipen NDC codes

Questions

Is there a generic for Epipen?

Yes. The generic name for Epipen is epinephrine. 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 Epipen?

The active ingredient in Epipen is epinephrine, 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.