FDA.reportPublic FDA data

INVOKANA

Product NDC
50090-5034
11-digit product format
500905034
Labeler code
50090
Product ID
50090-5034_f8148180-4b45-4670-a46c-94171161f367
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
canagliflozin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA204042
Marketing category
NDA
Marketing start
2013-03-29
Substance
CANAGLIFLOZIN
Active strength
100 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
CANAGLIFLOZIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0SAC974Z85
Rxcui1373463, 1373469

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
50090-5034-0INVOKANA90 in 1 BOTTLETABLET, FILM COATED909
50090-5034-1INVOKANA30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5034-0EA - Each50090-503446b3a97d-fac4-48de-9f9e-a938e3b922a312022-12-07
50090-5034-1EA - Each50090-5034ae7db2d1-3d6a-4d8c-a908-7abddac2b79812022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5034INVOKANA (CANAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20231216_8d5f892b-e4f3-4a9e-9a91-95e2fca34144.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373463canagliflozin 100 MG Oral TabletPSN8d5f892b-e4f3-4a9e-9a91-95e2fca341449
1373469Invokana 100 MG Oral TabletPSN8d5f892b-e4f3-4a9e-9a91-95e2fca341449
1373469canagliflozin 100 MG Oral Tablet [Invokana]SBD8d5f892b-e4f3-4a9e-9a91-95e2fca341449
1373463canagliflozin 100 MG Oral TabletSCD8d5f892b-e4f3-4a9e-9a91-95e2fca341449
1373463canagliflozin (as canagliflozin hemihydrate) 100 MG Oral TabletSY8d5f892b-e4f3-4a9e-9a91-95e2fca341449
1373469Invokana 100 MG Oral TabletSY8d5f892b-e4f3-4a9e-9a91-95e2fca341449

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5034-05009050340090 TABLET, FILM COATED in 1 BOTTLE (50090-5034-0) 2020-05-040000-00-00NoNoCurrent
50090-5034-15009050340130 TABLET, FILM COATED in 1 BOTTLE (50090-5034-1) 2020-05-050000-00-00NoNoCurrent