Voxzogo 0.4mg Kit
NDC Package 68135-082-36

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

Package Information

Voxzogo 0.4mg (vosoritide) kits is vOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses. This formulation utilizes a kit delivery system. Marketed by Biomarin Pharmaceutical Inc., this product is identified by NDC 68135-082 and is authorized under FDA application NDA214938.

Identification & Billing

NDC Package Code
68135-082-36
Package Description
1 KIT in 1 CARTON * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12)
Product Code
68135-082
11-Digit Billing Format
68135008236
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Voxzogo 0.4mg
Non-Proprietary Name
Vosoritide
Dosage Form
Kit - A packaged collection of related material.
Usage Information
VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia who are 5 years of age and older with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Biomarin Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214938
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-19-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68135-082-36 identifies a specific commercial package of 1 kit in 1 carton * 10 vial, single-dose in 1 carton (68135-061-00) / .5 ml in 1 vial, single-dose * 10 injection, solution in 1 carton (68135-070-12) of Voxzogo 0.4mg, a human prescription drug labeled by Biomarin Pharmaceutical Inc.. This kit is formulated for use and contains 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 November 19, 2021. 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: 68135008236. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
68135-082-36
11-Digit CMS (5-4-2)
68135-0082-36

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