Is there a generic for Prilocaine hydrochloride?

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

What is the reference-listed drug for Prilocaine hydrochloride?

CITANEST (NDA 014763, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Prilocaine hydrochloride are approved?

Prilocaine hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Prilocaine hydrochloride

Prilocaine hydrochloride is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CITANEST · NDA 014763

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CITANESTRLD×4	ASTRAZENECA	NDA 014763	—	Approved Prior to Jan 1, 1982
CITANEST PLAIN DENTALRLD	DENTSPLY PHARM	NDA 021382	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
PRILOCAINE HYDROCHLORIDE	SEPTODONT INC	ANDA 079235	—	Sep 29, 2010

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.

Prilocaine hydrochloride — frequently asked questions

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

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