Is there a generic for Phenylephrine hydrochloride; promethazine hydrochloride?

Yes. The FDA Orange Book lists 7 approved generic (ANDA) applications for Phenylephrine hydrochloride; promethazine hydrochloride, referencing the brand PHENERGAN VC. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Phenylephrine hydrochloride; promethazine hydrochloride?

PHENERGAN VC (NDA 008604, ANI PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

FDA Orange Book · active-ingredient family

Phenylephrine hydrochloride; promethazine hydrochloride

Phenylephrine hydrochloride; promethazine hydrochloride is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PHENERGAN VC · NDA 008604

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · syrup

Product	Applicant	Application	TE	Approved
PHENERGAN VCRLD	ANI PHARMS	NDA 008604	—	Apr 02, 1984

Generic (ANDA) products (7)

Product	Applicant	Application	TE	Approved
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	HIKMA	ANDA 040675	—	Dec 23, 2014
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	AMNEAL PHARMS	ANDA 040902	AA	Aug 25, 2009
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	PAI HOLDINGS	ANDA 040654	AA	Dec 07, 2006
PHERAZINE VC	HALSEY	ANDA 088868	—	Mar 02, 1987
PROMETHAZINE VC PLAIN	CENCI	ANDA 088815	—	Nov 22, 1985
PROMETHAZINE VC PLAIN	XTTRIUM LABS INC	ANDA 088897	—	Jan 04, 1985
PROMETH VC PLAINRLD	G AND W LABS INC	ANDA 088761	—	Nov 08, 1984

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.