Naglazyme Solution
NDC Package 68135-020-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Naglazyme (galsulfase) solution is galsulfase is used to treat a certain rare genetic problem (Maroteaux-Lamy syndrome - MLS). This formulation utilizes a solution delivery system. Marketed by Biomarin Pharmaceutical Inc., this product is identified by NDC 68135-020 and is authorized under FDA application BLA125117.

Identification & Billing

NDC Package Code
68135-020-99
Package Description
20000 mL in 1 BAG
Product Code
68135-020
11-Digit Billing Format
68135002099
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Naglazyme
Non-Proprietary Name
Galsulfase
Substance Name
Galsulfase
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Biomarin Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125117
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-09-2005
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68135-020). Click a package code to view its specific billing and regulatory data.

68135-020-01
1 VIAL in 1 CARTON / 5 mL in 1 VIAL

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68135-020-99 identifies a specific commercial package of 20000 ml in 1 bag of Naglazyme, a human prescription drug labeled by Biomarin Pharmaceutical Inc.. This solution is formulated for intravenous use and contains galsulfase as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Biomarin Pharmaceutical Inc. on June 09, 2005. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Biomarin Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68135002099. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68135-020-99
11-Digit CMS (5-4-2)
68135-0020-99

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.