INVOKANA
These highlights do not include all the information needed to use INVOKANA safely and effectively. See full prescribing information for INVOKANA. INVOKANA (canagliflozin) tablets, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
5f76e16f-0c24-454a-81af-4080b312c940
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2023
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
canagliflozin
PRODUCT DETAILS
NDC Product Code55154-1426
Application NumberNDA204042
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 13, 2018
Generic Namecanagliflozin
INGREDIENTS (11)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
canagliflozinActive
Quantity: 300 mg in 1 1
Code: 0SAC974Z85
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Hydroxypropyl Cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
canagliflozin
PRODUCT DETAILS
NDC Product Code55154-1425
Application NumberNDA204042
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateDecember 13, 2018
Generic Namecanagliflozin
INGREDIENTS (12)
canagliflozinActive
Quantity: 100 mg in 1 1
Code: 0SAC974Z85
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Hydroxypropyl Cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT