Fosrenol
NDC Package 54092-249-01

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

Package Information

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

Fosrenol is lanthanum is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Marketed by Shire Us Manufacturing Inc., this product is identified by NDC 54092-249 and is authorized under FDA application NDA021468.

Identification & Billing

NDC Package Code
54092-249-01
Package Description
100 TABLET, CHEWABLE in 1 BOTTLE
Product Code
54092-249
11-Digit Billing Format
54092024901

Clinical Specifications

Proprietary Name
Fosrenol
Dosage Form
-
Usage Information
Lanthanum is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. Lanthanum is a natural mineral that works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool.

Regulatory & Marketing

Labeler Name
Shire Us Manufacturing Inc.
FDA Application #
NDA021468
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-26-2004
End Marketing Date
05-31-2008
Listing Expiration
05-31-2008
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54092-249-01 identifies a specific commercial package of 100 tablet, chewable in 1 bottle of Fosrenol, labeled by Shire Us Manufacturing 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 Shire Us Manufacturing Inc. on October 26, 2004. The current certification is valid through May 31, 2008.

What are the primary indications for this medication?

Lanthanum is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. Lanthanum is a natural mineral that works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool.

How is this Shire Us Manufacturing Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54092024901. 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)
54092-249-01
11-Digit CMS (5-4-2)
54092-0249-01

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