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  5. NDC Package Code: 68135-082-36 Voxzogo 0.4mg

NDC Package 68135-082-36 Voxzogo 0.4mg

Vosoritide Kit - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
68135-082-36
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
Proprietary Name:
Voxzogo 0.4mg
Non-Proprietary Name:
Vosoritide
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).
11-Digit NDC Billing Format:
68135008236
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 2586364 - vosoritide 0.4 MG Injection
  • RxCUI: 2586369 - VOXZOGO 0.4 MG Injection
  • RxCUI: 2586369 - vosoritide 0.4 MG Injection [Voxzogo]
  • RxCUI: 2586369 - Voxzogo 0.4 MG Injection
  • RxCUI: 2586371 - vosoritide 0.56 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biomarin Pharmaceutical Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA214938
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-19-2021
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 68135-082-36?

    The NDC Packaged Code 68135-082-36 is assigned to a 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.. The product's dosage form is kit and is administered via form.

    Is NDC 68135-082 included in the NDC Directory?

    Yes, Voxzogo 0.4mg with product code 68135-082 is active and included in the NDC Directory. The product was first marketed by Biomarin Pharmaceutical Inc. on November 19, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68135-082-36?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 68135-082-36?

    The 11-digit format is 68135008236. 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
    5-3-268135-082-365-4-268135-0082-36