FDA.reportPublic FDA data

INVOKANA

Product NDC
50458-141
11-digit product format
504580141
Labeler code
50458
Product ID
50458-141_30ca5702-272c-7528-e063-6294a90abbc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
canagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA204042
Marketing category
NDA
Marketing start
2013-03-29
Substance
CANAGLIFLOZIN
Active strength
300 mg/1
Pharmacologic classes
P-Glycoprotein Inhibitors [MoA], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
INVOKANA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANAGLIFLOZIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0SAC974Z85
Rxcui1373463, 1373469, 1373471, 1373473

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
bfd158f9-2ca9-be9c-cd97-e30d4086e4adProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-141-01INVOKANA5 in 1 BOTTLETABLET, FILM COATED531
50458-141-10INVOKANA10 in 1 CARTONTABLET, FILM COATED1031
50458-141-10INVOKANA10 in 1 BLISTER PACKTABLET, FILM COATED1031
50458-141-30INVOKANA30 in 1 BOTTLETABLET, FILM COATED3031
50458-141-50INVOKANA500 in 1 BOTTLETABLET, FILM COATED50031
50458-141-90INVOKANA90 in 1 BOTTLETABLET, FILM COATED9031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-141-30EA - Each50458-14165790780-0bf0-409a-9c90-2949bf78905812013-05-02
50458-141-90EA - Each50458-1418f9dc7e3-f9c2-4f34-9041-ac4f6c8b629412013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
canagliflozinACTIVE INGREDIENT0SAC974Z85INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
canagliflozin anhydrousACTIVE MOIETY6S49DGR869INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8
WATERINACTIVE INGREDIENT059QF0KO0RINVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-141INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 6 package rows20250322_b9057d3b-b104-4f09-8a61-c61ef9d4a3f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373463canagliflozin 100 MG Oral TabletPSNb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373471canagliflozin 300 MG Oral TabletPSNb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373469Invokana 100 MG Oral TabletPSNb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373473Invokana 300 MG Oral TabletPSNb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373469canagliflozin 100 MG Oral Tablet [Invokana]SBDb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373473canagliflozin 300 MG Oral Tablet [Invokana]SBDb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373463canagliflozin 100 MG Oral TabletSCDb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373471canagliflozin 300 MG Oral TabletSCDb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373463canagliflozin (as canagliflozin hemihydrate) 100 MG Oral TabletSYb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373469Invokana 100 MG Oral TabletSYb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373473Invokana 300 MG Oral TabletSYb9057d3b-b104-4f09-8a61-c61ef9d4a3f331
1373463canagliflozin 100 MG Oral TabletPSN5f76e16f-0c24-454a-81af-4080b312c94014
1373471canagliflozin 300 MG Oral TabletPSN5f76e16f-0c24-454a-81af-4080b312c94014
1373469Invokana 100 MG Oral TabletPSN5f76e16f-0c24-454a-81af-4080b312c94014
1373473Invokana 300 MG Oral TabletPSN5f76e16f-0c24-454a-81af-4080b312c94014
1373469canagliflozin 100 MG Oral Tablet [Invokana]SBD5f76e16f-0c24-454a-81af-4080b312c94014
1373473canagliflozin 300 MG Oral Tablet [Invokana]SBD5f76e16f-0c24-454a-81af-4080b312c94014
1373463canagliflozin 100 MG Oral TabletSCD5f76e16f-0c24-454a-81af-4080b312c94014
1373471canagliflozin 300 MG Oral TabletSCD5f76e16f-0c24-454a-81af-4080b312c94014
1373463canagliflozin (as canagliflozin hemihydrate) 100 MG Oral TabletSY5f76e16f-0c24-454a-81af-4080b312c94014
1373469Invokana 100 MG Oral TabletSY5f76e16f-0c24-454a-81af-4080b312c94014
1373473Invokana 300 MG Oral TabletSY5f76e16f-0c24-454a-81af-4080b312c94014
1373471canagliflozin 300 MG Oral TabletPSN9679460c-55f7-4826-b55c-fe116f0203589
1373473Invokana 300 MG Oral TabletPSN9679460c-55f7-4826-b55c-fe116f0203589
1373473canagliflozin 300 MG Oral Tablet [Invokana]SBD9679460c-55f7-4826-b55c-fe116f0203589
1373471canagliflozin 300 MG Oral TabletSCD9679460c-55f7-4826-b55c-fe116f0203589
1373473Invokana 300 MG Oral TabletSY9679460c-55f7-4826-b55c-fe116f0203589
1373471canagliflozin 300 MG Oral TabletPSN4e946ba3-02c4-4a10-9d5e-f2d87b534dc35
1373473Invokana 300 MG Oral TabletPSN4e946ba3-02c4-4a10-9d5e-f2d87b534dc35
1373473canagliflozin 300 MG Oral Tablet [Invokana]SBD4e946ba3-02c4-4a10-9d5e-f2d87b534dc35
1373471canagliflozin 300 MG Oral TabletSCD4e946ba3-02c4-4a10-9d5e-f2d87b534dc35
1373473Invokana 300 MG Oral TabletSY4e946ba3-02c4-4a10-9d5e-f2d87b534dc35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-141-01504580141015 TABLET, FILM COATED in 1 BOTTLE (50458-141-01) 2013-03-290000-00-00YesNoCurrent
50458-141-105045801411010 BLISTER PACK in 1 CARTON (50458-141-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2013-03-290000-00-00NoNoCurrent
50458-141-305045801413030 TABLET, FILM COATED in 1 BOTTLE (50458-141-30) 2013-03-290000-00-00NoNoCurrent
50458-141-5050458014150500 TABLET, FILM COATED in 1 BOTTLE (50458-141-50) 2013-03-290000-00-00NoNoCurrent
50458-141-905045801419090 TABLET, FILM COATED in 1 BOTTLE (50458-141-90) 2013-03-290000-00-00NoNoCurrent