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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 019510

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NDA 019510 describes PEPCID PRESERVATIVE FREE, which is a drug marketed by Merck and Merck Sharp Dohme and is included in two NDAs. Additional details are available on the PEPCID PRESERVATIVE FREE profile page.

The generic ingredient in PEPCID PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty-one suppliers are listed for this compound. Additional details are available on the famotidine profile page.

Summary for 019510

Tradename:	PEPCID PRESERVATIVE FREE
Applicant:	Merck
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 019510

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 4, 1986	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 4, 1986	TE:		RLD:	Yes

Expired US Patents for NDA 019510

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	PEPCID	famotidine	INJECTABLE;INJECTION	019510-001	Nov 4, 1986	⤷ Get Started Free	⤷ Get Started Free
Merck	PEPCID PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	019510-004	Nov 4, 1986	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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