NDC Package 68135-020-01 Naglazyme

Galsulfase 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:
68135-020-01
Package Description:
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code:
Proprietary Name:
Naglazyme
Non-Proprietary Name:
Galsulfase
Substance Name:
Galsulfase
Usage Information:
Galsulfase is used to treat a certain rare genetic problem (Maroteaux-Lamy syndrome - MLS). Galsulfase replaces a certain natural substance that is missing in people with MLS. This medication improves how far you can walk and the number of stairs you can climb up. Galsulfase does not correct the genetic problem, and treatment must be continued for life.
11-Digit NDC Billing Format:
68135002001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 578037 - galsulfase 5 MG in 5 ML Injection
  • RxCUI: 578037 - 5 ML galsulfase 1 MG/ML Injection
  • RxCUI: 578037 - galsulfase 5 MG per 5 ML Injection
  • RxCUI: 584222 - Naglazyme 5 MG in 5 ML Injection
  • RxCUI: 584222 - 5 ML galsulfase 1 MG/ML Injection [Naglazyme]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biomarin Pharmaceutical Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    BLA125117
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-09-2005
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68135-020-9920000 mL in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68135-020-01?

    The NDC Packaged Code 68135-020-01 is assigned to a package of 1 vial in 1 carton / 5 ml in 1 vial of Naglazyme, a human prescription drug labeled by Biomarin Pharmaceutical Inc.. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 68135-020 included in the NDC Directory?

    Yes, Naglazyme with product code 68135-020 is active and included in the NDC Directory. The product was first marketed by Biomarin Pharmaceutical Inc. on June 09, 2005 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 68135-020-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 68135-020-01?

    The 11-digit format is 68135002001. 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 5-3-2 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
    5-3-268135-020-015-4-268135-0020-01