Last Updated: November 8, 2026

Details for New Drug Application (NDA): 074664

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NDA 074664 describes CIMETIDINE HYDROCHLORIDE, which is a drug marketed by 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 is one drug master file entry 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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