Is there a generic for Cephapirin sodium?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Cephapirin sodium, referencing the brand CEFADYL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cephapirin sodium?

CEFADYL (NDA 050446, APOTHECON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cephapirin sodium are approved?

Cephapirin sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Cephapirin sodium

Cephapirin sodium is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CEFADYL · NDA 050446

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CEFADYL×5	APOTHECON	NDA 050446	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (5)

Product	Applicant	Application	TE	Approved
CEFADYL×4	APOTHECON	ANDA 062961	—	Sep 20, 1988
CEPHAPIRIN SODIUM×4	HIKMA	ANDA 062720	—	Jul 02, 1987
CEFADYL×2	APOTHECON	ANDA 062724	—	Dec 23, 1986
CEPHAPIRIN SODIUM×5	ABRAXIS PHARM	ANDA 062723	—	Nov 17, 1986
CEFADYL×3	APOTHECON	ANDA 061769	—	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.

Cephapirin sodium — frequently asked questions

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

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