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 ID: 50458-941_2276e4f3-2afe-48ac-b293-fd4befeff063
• NDC: 50458-941
• Product Type: Human Prescription Drug
• Proprietary Name: INVOKAMET XR
• Generic Name: Canagliflozin And Metformin Hydrochloride
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-09-20
• Marketing Category: NDA / NDA
• Application Number: NDA205879
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
• Active Ingredient Strength: 50 mg/1; mg/1
• Pharm Classes: Sodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50458-941-01

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01)

• Marketing Start Date: 2016-09-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-941-01 [50458094101]

INVOKAMET XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA205879
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-20

NDC 50458-941-02 [50458094102]

INVOKAMET XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA205879
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-09-20
• Marketing End Date: 2020-02-07

Drug Details

Active Ingredients

Ingredient	Strength
CANAGLIFLOZIN	50 mg/1

OpenFDA Data

• SPL SET ID: 6868666b-c25e-40d1-9d1f-306bbe9390c1
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 786Z46389E
  • 0SAC974Z85
• 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"

NDC	Brand Name	Generic Name
50458-940	INVOKAMET XR	canagliflozin and metformin hydrochloride
50458-941	INVOKAMET XR	canagliflozin and metformin hydrochloride
50458-942	INVOKAMET XR	canagliflozin and metformin hydrochloride
50458-943	INVOKAMET XR	canagliflozin and metformin hydrochloride
50458-540	INVOKAMET	canagliflozin and metformin hydrochloride
50458-541	INVOKAMET	canagliflozin and metformin hydrochloride
50458-542	INVOKAMET	canagliflozin and metformin hydrochloride
50458-543	INVOKAMET	canagliflozin and metformin hydrochloride
63629-8260	INVOKAMET	canagliflozin and metformin hydrochloride