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  5. NDC Package Code: 58468-0040-1 Fabrazyme

NDC Package 58468-0040-1 Fabrazyme

Agalsidase Beta Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
58468-0040-1
Package Description:
1 VIAL, GLASS in 1 CARTON / 7 mL in 1 VIAL, GLASS
Product Code:
58468-0040
Proprietary Name:
Fabrazyme
Non-Proprietary Name:
Agalsidase Beta
Substance Name:
Agalsidase Beta
Usage Information:
This medication is used to treat a certain inherited disorder (Fabry disease) that causes buildup of a certain fat substance (GL-3) in some parts of your body. Worsening of this disorder can lead to kidney disease, heart attack, or stroke. Agalsidase beta works by replacing an enzyme that your body lacks, which helps break down the fat substance (GL-3) in your body. This can help prevent symptoms such as pain (especially in the hands and feet), dark red spots on the skin, a decreased ability to sweat, cloudiness of the front part of the eye, stomach/intestinal problems, ringing in the ears (tinnitus), and hearing loss.
11-Digit NDC Billing Format:
58468004001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1804755 - agalsidase beta 35 MG Injection
  • RxCUI: 1804758 - Fabrazyme 35 MG Injection
  • RxCUI: 1804758 - agalsidase beta 35 MG Injection [Fabrazyme]
  • RxCUI: 1804760 - agalsidase beta 5 MG Injection
  • RxCUI: 1804762 - Fabrazyme 5 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genzyme Corporation
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • AGALSIDASE BETA 5 mg/mL
    • Pharmacologic Class(es):
  • Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme - [EPC] (Established Pharmacologic Class)
  • alpha-Glucosidases - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA103979
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-17-2008
    Listing Expiration Date:
    12-31-2025
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 58468-0040-1 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    58468004001J0180Agalsidase beta injection1 MG113535

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58468-0040-1?

    The NDC Packaged Code 58468-0040-1 is assigned to a package of 1 vial, glass in 1 carton / 7 ml in 1 vial, glass of Fabrazyme, a human prescription drug labeled by Genzyme Corporation. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 58468-0040 included in the NDC Directory?

    Yes, Fabrazyme with product code 58468-0040 is active and included in the NDC Directory. The product was first marketed by Genzyme Corporation on December 17, 2008 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 58468-0040-1?

    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 1.

    What is the 11-digit format for NDC 58468-0040-1?

    The 11-digit format is 58468004001. 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 5-4-1 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
    5-4-158468-0040-15-4-258468-0040-01