NDC 50458-941

INVOKAMET XR

Canagliflozin And Metformin Hydrochloride

INVOKAMET XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Canagliflozin; Metformin Hydrochloride.

Product ID50458-941_2276e4f3-2afe-48ac-b293-fd4befeff063
NDC50458-941
Product TypeHuman Prescription Drug
Proprietary NameINVOKAMET XR
Generic NameCanagliflozin And Metformin Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-09-20
Marketing CategoryNDA / NDA
Application NumberNDA205879
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameCANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesSodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50458-941-01

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01)
Marketing Start Date2016-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-941-01 [50458094101]

INVOKAMET XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA205879
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-20

NDC 50458-941-02 [50458094102]

INVOKAMET XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA205879
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-20
Marketing End Date2020-02-07

Drug Details

Active Ingredients

IngredientStrength
CANAGLIFLOZIN50 mg/1

OpenFDA Data

SPL SET ID:6868666b-c25e-40d1-9d1f-306bbe9390c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1811003
  • 1810997
  • 1810999
  • 1811006
  • 1811007
  • 1811002
  • 1545164
  • 1811010
  • 1545159
  • 1811011
  • 1545161
  • 1545156
  • 1545157
  • 1545150
  • 1545163
  • 1545166
  • UPC Code
  • 0350458542608
  • 0350458540604
  • Pharmacological Class

    • Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
    • Sodium-Glucose Transporter 2 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]
    • Biguanide [EPC]
    • Biguanides [CS]

    Medicade Reported Pricing

    50458094101 INVOKAMET XR 50-1,000 MG TAB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "INVOKAMET XR" or generic name "Canagliflozin And Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    50458-940INVOKAMET XRcanagliflozin and metformin hydrochloride
    50458-941INVOKAMET XRcanagliflozin and metformin hydrochloride
    50458-942INVOKAMET XRcanagliflozin and metformin hydrochloride
    50458-943INVOKAMET XRcanagliflozin and metformin hydrochloride
    50458-540INVOKAMETcanagliflozin and metformin hydrochloride
    50458-541INVOKAMETcanagliflozin and metformin hydrochloride
    50458-542INVOKAMETcanagliflozin and metformin hydrochloride
    50458-543INVOKAMETcanagliflozin and metformin hydrochloride
    63629-8260INVOKAMETcanagliflozin and metformin hydrochloride

    Trademark Results [INVOKAMET XR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    INVOKAMET XR
    INVOKAMET XR
    86277042 5134045 Live/Registered
    JOHNSON & JOHNSON
    2014-05-09

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