Methenamine Mandelate
Methenamine Mandelate
Approved
Approval ID
cc299e8a-cf9a-4dc6-b6e6-972141e59296
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2021
Manufacturers
FDA
Edenbridge Pharmaceuticals LLC.
DUNS: 948715060
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methenamine Mandelate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42799-106
Product Classification
G
Generic Name
Methenamine Mandelate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2021
FDA Product Classification
INGREDIENTS (14)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
METHENAMINE MANDELATEActive
Quantity: 1000 mg in 1 1
Code: 695N30CINR
Classification: ACTIB
Methenamine Mandelate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42799-105
Product Classification
G
Generic Name
Methenamine Mandelate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2021
FDA Product Classification
INGREDIENTS (13)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
METHENAMINE MANDELATEActive
Quantity: 500 mg in 1 1
Code: 695N30CINR
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT