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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 218684

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NDA 218684 describes IBUPROFEN AND FAMOTIDINE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Ph Health, Teva Pharms Usa, Torrent, and Zydus Pharms, and is included in seven NDAs. It is available from fifteen suppliers. Additional details are available on the IBUPROFEN AND FAMOTIDINE profile page.

The generic ingredient in IBUPROFEN AND FAMOTIDINE is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

Summary for 218684

Tradename:	IBUPROFEN AND FAMOTIDINE
Applicant:	Zydus Pharms
Ingredient:	famotidine; ibuprofen
Patents:	0

Pharmacology for NDA: 218684

Mechanism of Action	Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 218684

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	218684	ANDA	Zydus Lifesciences Limited	70771-1924	70771-1924-9	90 TABLET in 1 BOTTLE (70771-1924-9)
IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	218684	ANDA	Viona Pharmaceuticals Inc	72578-214	72578-214-16	90 TABLET in 1 BOTTLE (72578-214-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	26.6MG;800MG
Approval Date:	Feb 20, 2025	TE:	AB	RLD:	No

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