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  5. NDC Package Code: 0955-1048-18 Sevelamer Hydrochloride

NDC Package 0955-1048-18 Sevelamer Hydrochloride

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0955-1048-18
Package Description:
180 TABLET, FILM COATED in 1 BOTTLE
Product Code:
0955-1048
Proprietary Name:
Sevelamer Hydrochloride
Non-Proprietary Name:
Sevelamer Hydrochloride
Substance Name:
Sevelamer Hydrochloride
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.
11-Digit NDC Billing Format:
00955104818
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
180 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 857224 - sevelamer HCl 800 MG Oral Tablet
  • RxCUI: 857224 - sevelamer hydrochloride 800 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SEVELAMER HYDROCHLORIDE 800 mg/1
    • Pharmacologic Class(es):
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    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
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0955-1048-18?

    The NDC Packaged Code 0955-1048-18 is assigned to a package of 180 tablet, film coated in 1 bottle of Sevelamer Hydrochloride, a human prescription drug labeled by Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0955-1048 included in the NDC Directory?

    Yes, Sevelamer Hydrochloride with product code 0955-1048 is active and included in the NDC Directory. The product was first marketed by Winthrop U.s, A Business Of Sanofi-aventis U.s. Llc on February 13, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0955-1048-18?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 180.

    What is the 11-digit format for NDC 0955-1048-18?

    The 11-digit format is 00955104818. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20955-1048-185-4-200955-1048-18