METHENAMINE HIPPURATE tablet

Methenamine hippurate by

Drug Labeling and Warnings

Methenamine hippurate by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited, Zydus Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1919-1

Methenamine Hippurate Tablets, USP 1gram

100 tablets

Rx only

INGREDIENTS AND APPEARANCE

METHENAMINE HIPPURATE 
methenamine hippurate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1919
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHENAMINE HIPPURATE (UNII: M329791L57) (METHENAMINE - UNII:J50OIX95QV)	METHENAMINE HIPPURATE	1 g

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	WHITE (WHITE TO OFF WHITE)	Score	2 pieces
Shape	CAPSULE (MODIFIED CAPSULE SHAPE)	Size	19mm
Flavor		Imprint Code	II;C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1919-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA219661	03/12/2025

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Pharmaceuticals Limited		650173735	MANUFACTURE(70771-1919) , ANALYSIS(70771-1919)