Vimizim Injection, Solution, Concentrate
NDC Package 68135-100-01

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

Vimizim (elosulfase alfa) injection is vimizim (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Biomarin Pharmaceutical Inc., this product is identified by NDC 68135-100 and is authorized under FDA application BLA125460.

Identification & Billing

NDC Package Code
68135-100-01
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
68135-100
11-Digit Billing Format
68135010001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vimizim
Non-Proprietary Name
Elosulfase Alfa
Substance Name
Elosulfase Alfa
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Vimizim (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome).

Regulatory & Marketing

Labeler Name
Biomarin Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125460
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-14-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 (68135-100). Click a package code to view its specific billing and regulatory data.

68135-100-99
20000 mL in 1 BAG

* 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 68135-100-01 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Vimizim, a human prescription drug labeled by Biomarin Pharmaceutical Inc.. This injection, solution, concentrate is formulated for intravenous use and contains elosulfase alfa 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 February 14, 2014. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68135010001. 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)
68135-100-01
11-Digit CMS (5-4-2)
68135-0100-01

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