Ulesfia
NDC Package 59212-780-08

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ulesfia is a . Marketed by Concordia Pharmaceuticals Inc., this product is identified by NDC 59212-780 and is authorized under FDA application NDA022129.

Identification & Billing

NDC Package Code
59212-780-08
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 227 g in 1 BOTTLE, PLASTIC
Product Code
59212-780
11-Digit Billing Format
59212078008

Clinical Specifications

Proprietary Name
Ulesfia
Dosage Form
-

Regulatory & Marketing

Labeler Name
Concordia Pharmaceuticals Inc.
FDA Application #
NDA022129
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-26-2009
End Marketing Date
07-22-2016
Listing Expiration
07-22-2016
Exclude Flag
D
Sample Package
No

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 (59212-780). Click a package code to view its specific billing and regulatory data.

59212-780-88
2 BOTTLE, PLASTIC in 1 CARTON / 227 g in 1 BOTTLE, PLASTIC

* 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 59212-780-08 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 227 g in 1 bottle, plastic of Ulesfia, labeled by Concordia Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Concordia Pharmaceuticals Inc. on May 26, 2009. The current certification is valid through July 22, 2016.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59212078008. 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)
59212-780-08
11-Digit CMS (5-4-2)
59212-0780-08

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