Is there a generic for Epinephrine bitartrate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Epinephrine bitartrate. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Epinephrine bitartrate?

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (NDA 218475, BAXTER HLTHCARE CORP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Epinephrine bitartrate are approved?

Epinephrine bitartrate is approved in the following dosage forms: aerosol, metered, solution.

FDA Orange Book · active-ingredient family

Epinephrine bitartrate

Epinephrine bitartrate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · NDA 218475

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · aerosol, metered, solution

Product	Applicant	Application	TE	Approved
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDERLD×2	BAXTER HLTHCARE CORP	NDA 218475	—	Mar 16, 2026
BRONITIN MIST	WYETH CONS	NDA 016126	—	Approved Prior to Jan 1, 1982
MEDIHALER-EPI	3M	NDA 010374	—	Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Epinephrine bitartrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo