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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 020958

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NDA 020958 describes PEPCID COMPLETE, which is a drug marketed by Kenvue Brands and is included in one NDA. It is available from six suppliers. Additional details are available on the PEPCID COMPLETE profile page.

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

Summary for 020958

Tradename:	PEPCID COMPLETE
Applicant:	Kenvue Brands
Ingredient:	calcium carbonate; famotidine; magnesium hydroxide
Patents:	0

Pharmacology for NDA: 020958

Mechanism of Action	Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 020958

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958	NDA	Kenvue Brands LLC	16837-246	16837-246-25	25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25)
PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958	NDA	Kenvue Brands LLC	16837-246	16837-246-50	50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET, CHEWABLE;ORAL			Strength	800MG;10MG;165MG
Approval Date:	Oct 16, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 020958

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,989,588*PED	⤷ Get Started Free
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	4,283,408*PED	⤷ Get Started Free
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	6,814,978*PED	⤷ Get Started Free
Kenvue Brands	PEPCID COMPLETE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	020958-001	Oct 16, 2000	5,817,340*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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