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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 074664

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NDA 074664 describes CIMETIDINE HYDROCHLORIDE, which is a drug marketed by Cosette, Hospira, Luitpold, Ph Health, Teva Parenteral, Ani Pharms, Chartwell Molecular, Cycle, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-one NDAs. It is available from three suppliers. Additional details are available on the CIMETIDINE HYDROCHLORIDE profile page.

The generic ingredient in CIMETIDINE HYDROCHLORIDE is cimetidine hydrochloride. There are twenty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for 074664

Tradename:	CIMETIDINE HYDROCHLORIDE
Applicant:	Pai Holdings Pharm
Ingredient:	cimetidine hydrochloride
Patents:	0

Pharmacology for NDA: 074664

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 074664

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074664	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1025	0121-1025-08	237 mL in 1 BOTTLE (0121-1025-08)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 300MG BASE/5ML
Approval Date:	Oct 28, 1997	TE:	AA	RLD:	No

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