invokana

Generic: canagliflozin

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

Drug Facts

Product Profile

Brand Name invokana
Generic Name canagliflozin
Labeler janssen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

canagliflozin 300 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-141
Product ID 50458-141_30ca5702-272c-7528-e063-6294a90abbc1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204042
Listing Expiration 2026-12-31
Marketing Start 2013-03-29

Pharmacologic Class

Classes
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 50458141
Hyphenated Format 50458-141

Supplemental Identifiers

RxCUI
1373463 1373469 1373471 1373473
UPC
0350458141900 0350458140903
UNII
0SAC974Z85

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 invokana (source: ndc)
Generic Name canagliflozin (source: ndc)
Application Number NDA204042 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 5 TABLET, FILM COATED in 1 BOTTLE (50458-141-01)
  • 10 BLISTER PACK in 1 CARTON (50458-141-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (50458-141-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE (50458-141-50)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50458-141-90)
source: ndc

Packages (5)

50458-141-01 5 TABLET, FILM COATED in 1 BOTTLE (50458-141-01) 50458-141-10 10 BLISTER PACK in 1 CARTON (50458-141-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 50458-141-30 30 TABLET, FILM COATED in 1 BOTTLE (50458-141-30) 50458-141-50 500 TABLET, FILM COATED in 1 BOTTLE (50458-141-50) 50458-141-90 90 TABLET, FILM COATED in 1 BOTTLE (50458-141-90)

Ingredients (1)

canagliflozin (300 mg/1)

Linked Drug Pages (1)

INVOKANA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "30ca5702-272c-7528-e063-6294a90abbc1", "openfda": {"upc": ["0350458141900", "0350458140903"], "unii": ["0SAC974Z85"], "rxcui": ["1373463", "1373469", "1373471", "1373473"], "spl_set_id": ["b9057d3b-b104-4f09-8a61-c61ef9d4a3f3"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "5 TABLET, FILM COATED in 1 BOTTLE (50458-141-01)", "package_ndc": "50458-141-01", "marketing_start_date": "20130329"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (50458-141-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50458-141-10", "marketing_start_date": "20130329"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50458-141-30)", "package_ndc": "50458-141-30", "marketing_start_date": "20130329"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (50458-141-50)", "package_ndc": "50458-141-50", "marketing_start_date": "20130329"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50458-141-90)", "package_ndc": "50458-141-90", "marketing_start_date": "20130329"}], "brand_name": "INVOKANA", "product_id": "50458-141_30ca5702-272c-7528-e063-6294a90abbc1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["P-Glycoprotein Inhibitors [MoA]", "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]", "Sodium-Glucose Transporter 2 Inhibitors [MoA]"], "product_ndc": "50458-141", "generic_name": "canagliflozin", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INVOKANA", "active_ingredients": [{"name": "CANAGLIFLOZIN", "strength": "300 mg/1"}], "application_number": "NDA204042", "marketing_category": "NDA", "marketing_start_date": "20130329", "listing_expiration_date": "20261231"}