Methenamine Hippurate
Methenamine Hippurate Tablets, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate and other antibacterial drugs, methenamine hippurate tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Approved
Approval ID
e07ddd63-4725-49db-bec2-bd4f966c6e48
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 25, 2021
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
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 Code42571-332
Application NumberANDA212172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methenamine Hippurate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2021
FDA Product Classification
INGREDIENTS (4)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
METHENAMINE HIPPURATEActive
Quantity: 1000 mg in 1 1
Code: M329791L57
Classification: ACTIB