invokamet xr

Generic: canagliflozin and metformin hydrochloride

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name invokamet xr
Generic Name canagliflozin and metformin hydrochloride
Labeler janssen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

canagliflozin 50 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-941
Product ID 50458-941_3ce5755e-f0a3-692b-e063-6294a90a3c1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205879
Listing Expiration 2026-12-31
Marketing Start 2016-09-20

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] p-glycoprotein inhibitors [moa] sodium-glucose cotransporter 2 inhibitor [epc] sodium-glucose transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458941
Hyphenated Format 50458-941

Supplemental Identifiers

RxCUI
1545150 1545156 1545157 1545159 1545161 1545163 1545164 1545166 1810997 1810999 1811002 1811003 1811006 1811007 1811010 1811011
UPC
0350458543605 0350458541601
UNII
0SAC974Z85 786Z46389E

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name invokamet xr (source: ndc)
Generic Name canagliflozin and metformin hydrochloride (source: ndc)
Application Number NDA205879 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01)
source: ndc

Packages (1)

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

Ingredients (2)

canagliflozin (50 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

INVOKAMET, INVOKAMET XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3ce5755e-f0a3-692b-e063-6294a90a3c1f", "openfda": {"upc": ["0350458543605", "0350458541601"], "unii": ["0SAC974Z85", "786Z46389E"], "rxcui": ["1545150", "1545156", "1545157", "1545159", "1545161", "1545163", "1545164", "1545166", "1810997", "1810999", "1811002", "1811003", "1811006", "1811007", "1811010", "1811011"], "spl_set_id": ["6868666b-c25e-40d1-9d1f-306bbe9390c1"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01)", "package_ndc": "50458-941-01", "marketing_start_date": "20160920"}], "brand_name": "INVOKAMET XR", "product_id": "50458-941_3ce5755e-f0a3-692b-e063-6294a90a3c1f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "P-Glycoprotein Inhibitors [MoA]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "50458-941", "generic_name": "canagliflozin and metformin hydrochloride", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INVOKAMET XR", "active_ingredients": [{"name": "CANAGLIFLOZIN", "strength": "50 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA205879", "marketing_category": "NDA", "marketing_start_date": "20160920", "listing_expiration_date": "20261231"}