Sevelamer Hydrochloride
NDC Package 0955-5902-18

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.

Sevelamer Hydrochloride is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0955-5902 and is authorized under FDA application NDA021179.

Identification & Billing

NDC Package Code
0955-5902-18
Package Description
180 TABLET, FILM COATED in 1 BOTTLE
Product Code
0955-5902
11-Digit Billing Format
00955590218

Clinical Specifications

Proprietary Name
Sevelamer Hydrochloride
Dosage Form
-
Usage Information
Sevelamer hydrochloride is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride in CKD patients who are not on dialysis have not been studied.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
FDA Application #
NDA021179
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
02-13-2019
End Marketing Date
04-30-2026
Listing Expiration
04-30-2026
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 0955-5902-18 identifies a specific commercial package of 180 tablet, film coated in 1 bottle of Sevelamer Hydrochloride, labeled by Sanofi-aventis U.s. Llc. 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 Sanofi-aventis U.s. Llc on February 13, 2019. The current certification is valid through April 30, 2026.

How is this Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00955590218. 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 (4-4-2)
0955-5902-18
11-Digit CMS (5-4-2)
00955-5902-18

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