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Methenamine Hippurate

Methenamine Hippurate Tablets USP Rx only

Approved
Approval ID

3c9e5bea-f61d-48c3-8e05-640eccccf2ba

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 7, 2025

Manufacturers
FDA

NorthStar Rx LLC

DUNS: 830546433

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Methenamine Hippurate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72603-816
Application NumberANDA205661
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methenamine Hippurate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 7, 2025
FDA Product Classification

INGREDIENTS (4)

METHENAMINE HIPPURATEActive
Quantity: 1 g in 1 1
Code: M329791L57
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT

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Methenamine Hippurate - FDA Drug Approval Details