FDA.reportPublic FDA data

INVOKAMET

Product NDC
50458-542
11-digit product format
504580542
Labeler code
50458
Product ID
50458-542_3ce5755e-f0a3-692b-e063-6294a90a3c1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
canagliflozin and metformin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc.
Application
NDA204353
Marketing category
NDA
Marketing start
2014-08-08
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
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
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
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
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
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
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-542-60INVOKAMET60 in 1 BOTTLETABLET, FILM COATED6031
50458-542-91INVOKAMET10 in 1 BOTTLETABLET, FILM COATED1031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-542-60EA - Each50458-54251a29894-84c6-4961-ae8f-b2b46978b05d12014-09-03

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
50458-542INVOKAMET (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
50458-542-605045805426060 TABLET, FILM COATED in 1 BOTTLE (50458-542-60) 2014-08-080000-00-00NoNoCurrent
50458-542-915045805429110 in 1 BOTTLEHistorical