FDA.reportPublic FDA data

INVOKAMET XR

Product NDC
50458-942
11-digit product format
504580942
Labeler code
50458
Product ID
50458-942_3ce5755e-f0a3-692b-e063-6294a90a3c1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
canagliflozin and metformin hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA205879
Marketing category
NDA
Marketing start
2016-09-20
Substance
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active strength
150; 500 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], 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
INVOKAMET XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANAGLIFLOZIN150 mg/1
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E, 0SAC974Z85
Rxcui1545150, 1545156, 1545157, 1545159, 1545161, 1545163, 1545164, 1545166, 1810997, 1810999, 1811002, 1811003, 1811006, 1811007, 1811010, 1811011

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
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25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
bfd158f9-2ca9-be9c-cd97-e30d4086e4adProduct name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50458-942-012024-01-31C16284748780-11030e365-09e3-111a-e063-dadaa90a10e2These 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) tablets, for oral use INVOKAMET ® XR (canagliflozin and metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014
50458-942-022024-01-31C16284748780-11030e365-09e3-111a-e063-dadaa90a10e2These 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) tablets, for oral use INVOKAMET ® XR (canagliflozin and metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014
50458-942-012024-01-30C16284748780-11030e365-09e3-111a-e063-dadaa90a10e2These 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) tablets, for oral use INVOKAMET ® XR (canagliflozin and metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014
50458-942-022024-01-30C16284748780-11030e365-09e3-111a-e063-dadaa90a10e2These 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) tablets, for oral use INVOKAMET ® XR (canagliflozin and metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-942-01INVOKAMET XR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6031
50458-942-02INVOKAMET XR10 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-942-01EA - Each50458-942af3001b1-cac4-4d1d-b0e2-3ee0b8a9957f12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
canagliflozinACTIVE INGREDIENT0SAC974Z85INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
metformin hydrochlorideACTIVE INGREDIENT786Z46389EINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
canagliflozin anhydrousACTIVE MOIETY6S49DGR869INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
metforminACTIVE MOIETY9100L32L2NINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
ferric oxide redINACTIVE INGREDIENT1K09F3G675INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
magnesium stearateINACTIVE INGREDIENT70097M6I30INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
polyvinyl alcoholINACTIVE INGREDIENT532B59J990INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
talcINACTIVE INGREDIENT7SEV7J4R1UINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RINVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [JANSSEN PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-942INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED INVOKAMET XR (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]30Current NDC, Legacy NDC, 2 package rows20250101_6868666b-c25e-40d1-9d1f-306bbe9390c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1810997canagliflozin 150 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545150canagliflozin 150 MG / metFORMIN HCl 1000 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1811002canagliflozin 150 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545157canagliflozin 150 MG / metFORMIN HCl 500 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1811006canagliflozin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545161canagliflozin 50 MG / metFORMIN HCl 1000 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1811010canagliflozin 50 MG / metFORMIN HCl 500 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545164canagliflozin 50 MG / metFORMIN HCl 500 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545156Invokamet 150 MG / 1000 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545159Invokamet 150 MG / 500 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545163Invokamet 50 MG / 1000 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1545166Invokamet 50 MG / 500 MG Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1810999Invokamet XR 150 MG / 1000 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1811003Invokamet XR 150 MG / 500 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1811007Invokamet XR 50 MG / 1000 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
1811011Invokamet XR 50 MG / 500 MG 24HR Extended Release Oral TabletPSN6868666b-c25e-40d1-9d1f-306bbe9390c131
181099924 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
181100324 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
181100724 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
181101124 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545156canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545159canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545163canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545166canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]SBD6868666b-c25e-40d1-9d1f-306bbe9390c131
181099724 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
181100224 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
181100624 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
181101024 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545150canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545157canagliflozin 150 MG / metformin hydrochloride 500 MG Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545161canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
1545164canagliflozin 50 MG / metformin hydrochloride 500 MG Oral TabletSCD6868666b-c25e-40d1-9d1f-306bbe9390c131
1810997canagliflozin 150 MG / metformin hydrochloride 1000 MG 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1811002canagliflozin 150 MG / metformin hydrochloride 500 MG 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1811006canagliflozin 50 MG / metformin hydrochloride 1000 MG 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1811010canagliflozin 50 MG / metformin hydrochloride 500 MG 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1811007IInvokamet (canagliflozin 50 MG / metformin hydrochloride 1000 MG) 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1811011IInvokamet (canagliflozin 50 MG / metformin hydrochloride 500 MG) 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1810999Invokamet (canagliflozin 150 MG / metformin hydrochloride 1000 MG) 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1545156Invokamet (canagliflozin 150 MG / metformin hydrochloride 1000 MG) Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1811003Invokamet (canagliflozin 150 MG / metformin hydrochloride 500 MG) 24HR Extended Release Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1545159Invokamet (canagliflozin 150 MG / metformin hydrochloride 500 MG) Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1545163Invokamet (canagliflozin 50 MG / metformin hydrochloride 1000 MG) Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131
1545166Invokamet (canagliflozin 50 MG / metformin hydrochloride 500 MG) Oral TabletSY6868666b-c25e-40d1-9d1f-306bbe9390c131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50458-942-015045809420160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-942-01) 2016-09-200000-00-00NoNoCurrent
50458-942-025045809420210 in 1 BOTTLEHistorical