Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carilion Materials Management
079239644
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
Carilion Materials Management
079239644
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
68151-0984Application Number
ANDA076411Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 18, 2014SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
HexamethylenetetramineActive
Code: M329791L57Class: ACTIBQuantity: 1 g in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT