NDC Package 58468-0070-1 Aldurazyme

Laronidase Injection, Solution, Concentrate 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:
58468-0070-1
Package Description:
5 mL in 1 VIAL, GLASS
Product Code:
Proprietary Name:
Aldurazyme
Non-Proprietary Name:
Laronidase
Substance Name:
Laronidase
Usage Information:
ALDURAZYME® is indicated for adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms.  Limitations of Use:The risks and benefits of treating mildly affected patients with the Scheie form have not been established.ALDURAZYME has not been evaluated for effects on the central nervous system manifestations of the disorder.
11-Digit NDC Billing Format:
58468007001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
5 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 403822 - laronidase 2.9 MG in 5 ML Injection
  • RxCUI: 403822 - 5 ML laronidase 0.58 MG/ML Injection
  • RxCUI: 403822 - laronidase 2.9 MG per 5 ML Injection
  • RxCUI: 404492 - ALDURAZYME 2.9 MG in 5 ML Injection
  • RxCUI: 404492 - 5 ML laronidase 0.58 MG/ML Injection [Aldurazyme]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genzyme Corporation
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA125058
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-30-2003
    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.

    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 58468-0070-1 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    58468007001J1931Laronidase injection0.1 MG512929

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 58468-0070-1?

    The NDC Packaged Code 58468-0070-1 is assigned to a package of 5 ml in 1 vial, glass of Aldurazyme, a human prescription drug labeled by Genzyme Corporation. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package.

    Is NDC 58468-0070 included in the NDC Directory?

    Yes, Aldurazyme with product code 58468-0070 is active and included in the NDC Directory. The product was first marketed by Genzyme Corporation on April 30, 2003 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 58468-0070-1?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 5.

    What is the 11-digit format for NDC 58468-0070-1?

    The 11-digit format is 58468007001. 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
    5-4-158468-0070-15-4-258468-0070-01