Invokana Tablet, Film Coated
NDC Package 50458-141-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Invokana (canagliflozin) tablets is canagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a tablet, film coated delivery system. Marketed by Janssen Pharmaceuticals, Inc., this product is identified by NDC 50458-141 and is authorized under FDA application NDA204042.

Identification & Billing

NDC Package Code
50458-141-01
Package Description
5 TABLET, FILM COATED in 1 BOTTLE
Product Code
50458-141
11-Digit Billing Format
50458014101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Invokana
Non-Proprietary Name
Canagliflozin
Substance Name
Canagliflozin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CANAGLIFLOZIN 300 mg/1
Pharmacologic Class
Usage Information
Canagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Canagliflozin is also used by people with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Canagliflozin is also used by people with type 2 diabetes and kidney disease to lower the risk of dialysis, death from heart disease, and the need to go to the hospital for heart failure. Canagliflozin works by increasing the removal of sugar by your kidneys.

Regulatory & Marketing

Labeler Name
Janssen Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA204042
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-29-2013
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50458-141). Click a package code to view its specific billing and regulatory data.

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

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50458-141-01 identifies a specific commercial package of 5 tablet, film coated in 1 bottle of Invokana, a human prescription drug labeled by Janssen Pharmaceuticals, Inc.. This tablet, film coated is formulated for oral use and contains canagliflozin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Janssen Pharmaceuticals, Inc. on March 29, 2013. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Canagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Canagliflozin is also used by people with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Canagliflozin is also used by people with type 2 diabetes and kidney disease to lower the risk of dialysis, death from heart disease, and the need to go to the hospital for heart failure. Canagliflozin works by increasing the removal of sugar by your kidneys.

How is this Janssen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50458014101. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50458-141-01
11-Digit CMS (5-4-2)
50458-0141-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.