Is there a generic for Piperacillin sodium?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Piperacillin sodium, referencing the brand PIPRACIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Piperacillin sodium?

PIPRACIL (NDA 050545, WYETH PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Piperacillin sodium are approved?

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

FDA Orange Book · active-ingredient family

Piperacillin sodium

Piperacillin sodium is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PIPRACIL · NDA 050545

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
PIPRACILRLD×4	WYETH PHARMS INC	NDA 050545	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
PIPERACILLIN	ISTITUTO BIO ITA SPA	ANDA 065157	—	Jul 12, 2004
PIPERACILLIN×3	ISTITUTO BIO ITA SPA	ANDA 065114	—	Nov 14, 2003
PIPRACIL×3	WYETH PHARMS INC	ANDA 062750	—	Oct 13, 1987

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.

Piperacillin sodium — frequently asked questions

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

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