Last Updated: May 3, 2026

Details for New Drug Application (NDA): 019527

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NDA 019527 describes PEPCID, which is a drug marketed by Salix Pharms, Merck, Bausch, Kenvue Brands, J And J Consumer Inc, and Merck Sharp Dohme, and is included in nine NDAs. Additional details are available on the PEPCID profile page.

The generic ingredient in PEPCID is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 019527

Tradename:	PEPCID
Applicant:	Salix Pharms
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 019527

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	40MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 2, 1987	TE:		RLD:	Yes

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