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FDA Approval

Methenamine Mandelate

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

FDA Approval Summary

Company

Edenbridge Pharmaceuticals LLC.

DUNS: 948715060

Effective Date

November 8, 2021

Labeling Type

Human Prescription Drug Label

Active Ingredients

Hexamethylenetetramine(1000 mg in 1 1)

Products2

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

Methenamine Mandelate

Product Details

NDC Product Code

42799-106

Route of Administration

ORAL

Effective Date

November 10, 2021

Ingredients

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2DClass: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IEClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MAGNESIUM ALUMINUM SILICATEInactive

Code: 6M3P64V0NCClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7UClass: IACT

HexamethylenetetramineActive

Code: 695N30CINRClass: ACTIBQuantity: 1000 mg in 1 1

Methenamine Mandelate

Product Details

NDC Product Code

42799-105

Route of Administration

ORAL

Effective Date

November 10, 2021

Ingredients

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

HexamethylenetetramineActive

Code: 695N30CINRClass: ACTIBQuantity: 500 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYDEXTROSEInactive

Code: VH2XOU12IEClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2DClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MAGNESIUM ALUMINUM SILICATEInactive

Code: 6M3P64V0NCClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

MEDIUM-CHAIN TRIGLYCERIDESInactive

Code: C9H2L21V7UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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