Methenamine Hippurate
Methenamine Hippurate Tablets USP Rx only
Approved
Approval ID
9f002ad9-58e7-44f2-a980-3cc3f36bbd9b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2024
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code65862-782
Application NumberANDA205661
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methenamine Hippurate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2024
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