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FDA Approval

Methenamine Hippurate

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

FDA Approval Summary

Company
Micro Labs Limited
DUNS: 862174955
Effective Date
November 25, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hexamethylenetetramine(1000 mg in 1 1)

Manufacturing Establishments1

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

Micro Labs Limited

Micro Labs Limited

915793658

Products1

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

Methenamine Hippurate

Product Details

NDC Product Code
42571-332
Application Number
ANDA212172
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 25, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
Code: M329791L57Class: ACTIBQuantity: 1000 mg in 1 1
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