INVOKAMET

These highlights do not include all the information needed to use INVOKAMET or INVOKAMET XR safely and effectively. See full prescribing information for INVOKAMET or INVOKAMET XR. INVOKAMET (canagliflozin and metformin hydrochloride (HCl) tablets), for oral use INVOKAMET XR (canagliflozin and metformin HCl extended-release tablets), for oral use Initial U.S. Approval: 2014

Approved

Approval ID

6868666b-c25e-40d1-9d1f-306bbe9390c1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 30, 2024

Manufacturers

FDA

Janssen Pharmaceuticals, Inc.

DUNS: 063137772

Products 8

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

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-543

Application NumberNDA204353

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (13)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CANAGLIFLOZINActive

Quantity: 150 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-940

Application NumberNDA205879

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (14)

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

CANAGLIFLOZINActive

Quantity: 50 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

METFORMIN HYDROCHLORIDEActive

Quantity: 500 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-942

Application NumberNDA205879

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (14)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

CANAGLIFLOZINActive

Quantity: 150 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 500 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-542

Application NumberNDA204353

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (13)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

CANAGLIFLOZINActive

Quantity: 150 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

METFORMIN HYDROCHLORIDEActive

Quantity: 500 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-540

Application NumberNDA204353

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (11)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CANAGLIFLOZINActive

Quantity: 50 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 500 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-541

Application NumberNDA204353

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (13)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5P

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

CANAGLIFLOZINActive

Quantity: 50 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-943

Application NumberNDA205879

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CANAGLIFLOZINActive

Quantity: 150 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

METFORMIN HYDROCHLORIDEActive

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

canagliflozin and metformin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code50458-941

Application NumberNDA205879

Product Classification

Marketing Category

C73594

Generic Name

canagliflozin and metformin hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateJanuary 30, 2024

FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

CANAGLIFLOZINActive

Quantity: 50 mg in 1 1

Code: 0SAC974Z85

Classification: ACTIM

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

METFORMIN HYDROCHLORIDEActive

Quantity: 1000 mg in 1 1

Code: 786Z46389E

Classification: ACTIB

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INVOKAMET

Products 8

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

canagliflozin and metformin hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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