NDC Package 58468-0160-2 Lumizyme

Alglucosidase Alfa Injection, Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
58468-0160-2
Package Description:
10 VIAL, SINGLE-USE in 1 CARTON / 10.5 mL in 1 VIAL, SINGLE-USE
Product Code:
Proprietary Name:
Lumizyme
Non-Proprietary Name:
Alglucosidase Alfa
Substance Name:
Alglucosidase Alfa
Usage Information:
LUMIZYME® (alglucosidase alfa) [see Description (11)] is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency).
11-Digit NDC Billing Format:
58468016002
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: 629568 - alglucosidase alfa 50 MG Injection
  • RxCUI: 993072 - Lumizyme 50 MG Injection
  • RxCUI: 993072 - alglucosidase alfa 50 MG Injection [Lumizyme]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genzyme Corporation
    Dosage Form:
    Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA125291
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-24-2010
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    58468-0160-11 VIAL, SINGLE-USE in 1 CARTON / 10.5 mL in 1 VIAL, SINGLE-USE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58468-0160-2?

    The NDC Packaged Code 58468-0160-2 is assigned to a package of 10 vial, single-use in 1 carton / 10.5 ml in 1 vial, single-use of Lumizyme, a human prescription drug labeled by Genzyme Corporation. The product's dosage form is injection, powder, 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 58468-0160 included in the NDC Directory?

    Yes, Lumizyme with product code 58468-0160 is active and included in the NDC Directory. The product was first marketed by Genzyme Corporation on May 24, 2010 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 58468-0160-2?

    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 58468-0160-2?

    The 11-digit format is 58468016002. 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
    5-4-158468-0160-25-4-258468-0160-02