Is there a generic for Hetacillin?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Hetacillin, referencing the brand VERSAPEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hetacillin?

VERSAPEN (NDA 050060, BRISTOL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hetacillin are approved?

Hetacillin is approved in the following dosage form: for suspension.

FDA Orange Book · active-ingredient family

Hetacillin

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

Reference-listed drug:VERSAPEN · NDA 050060

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for suspension

Product	Applicant	Application	TE	Approved
VERSAPEN×2	BRISTOL	NDA 050060	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
VERSAPEN×2	BRISTOL	ANDA 061398	—	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.

Hetacillin — frequently asked questions

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

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