Renagel
NDC Package 17856-0021-2

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 inactivated by the FDA.

Renagel is sevelamer is used to lower high blood phosphorus (phosphate) levels in patients who are on dialysis due to severe kidney disease. Marketed by Atlantic Biologicals Corps, this product is identified by NDC 17856-0021 and is authorized under FDA application NDA021179.

Identification & Billing

NDC Package Code
17856-0021-2
Package Description
1 TABLET in 1 POUCH
Product Code
17856-0021
11-Digit Billing Format
17856002102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Renagel
Dosage Form
-
Usage Information
Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients 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 possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Sevelamer works by holding onto phosphate from the diet so that it can pass out of your body.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corps
FDA Application #
NDA021179
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-06-2008
Listing Expiration
12-31-2018
Exclude Flag
I
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 17856-0021-2 identifies a specific commercial package of 1 tablet in 1 pouch of Renagel, labeled by Atlantic Biologicals Corps. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Atlantic Biologicals Corps on June 06, 2008. The current certification is valid through December 31, 2018.

What are the primary indications for this medication?

Sevelamer is used to lower high blood phosphorus (phosphate) levels in patients 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 possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Sevelamer works by holding onto phosphate from the diet so that it can pass out of your body.

How is this Atlantic Biologicals Corps product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856002102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (5-4-1)
17856-0021-2
11-Digit CMS (5-4-2)
17856-0021-02

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