Methenamine Hippurate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 650082092

Effective Date

January 23, 2024

Labeling Type

Human Prescription Drug Label

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Aurobindo Pharma Limited

DUNS Number

650381903

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

NDC Product Code

65862-782

Application Number

ANDA205661

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 23, 2024

Ingredients

Code: M329791L57Class: ACTIBQuantity: 1 g in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT