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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219661

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NDA 219661 describes METHENAMINE HIPPURATE, which is a drug marketed by Aurobindo Pharma Ltd, Impax Labs Inc, Jubilant Cadista, Micro Labs, Novast Labs, and Zydus Lifesciences, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the METHENAMINE HIPPURATE profile page.

The generic ingredient in METHENAMINE HIPPURATE is methenamine hippurate. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methenamine hippurate profile page.

Summary for 219661

Tradename:	METHENAMINE HIPPURATE
Applicant:	Zydus Lifesciences
Ingredient:	methenamine hippurate
Patents:	0

Medical Subject Heading (MeSH) Categories for 219661

Anti-Infective Agents, Urinary

Suppliers and Packaging for NDA: 219661

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHENAMINE HIPPURATE	methenamine hippurate	TABLET;ORAL	219661	ANDA	Zydus Lifesciences Limited	70771-1919	70771-1919-1	100 TABLET in 1 BOTTLE (70771-1919-1)
METHENAMINE HIPPURATE	methenamine hippurate	TABLET;ORAL	219661	ANDA	Viona Pharmaceuticals Inc	72578-175	72578-175-01	100 TABLET in 1 BOTTLE (72578-175-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Mar 10, 2025	TE:	AB	RLD:	No

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