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  5. NDC Package Code: 68135-811-02 Brineura

NDC Package 68135-811-02 Brineura

Cerliponase Alfa 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:
68135-811-02
Package Description:
1 KIT in 1 CARTON * 5 mL in 1 VIAL, GLASS (68135-500-00) * 5 mL in 1 VIAL, GLASS (68135-495-04)
Product Code:
68135-811
Proprietary Name:
Brineura
Non-Proprietary Name:
Cerliponase Alfa
Usage Information:
Brineura is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
11-Digit NDC Billing Format:
68135081102
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1922453 - cerliponase alfa 150 MG in 5 mL Intraventricular Injection
  • RxCUI: 1922453 - 5 ML cerliponase alfa 30 MG/ML Injection
  • RxCUI: 1922453 - cerliponase alfa 150 MG per 5 ML Intraventricular Injection
  • RxCUI: 1922458 - Brineura 150 MG in 5 mL Intraventricular Injection
  • RxCUI: 1922458 - 5 ML cerliponase alfa 30 MG/ML Injection [Brineura]
    • 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:
    BLA761052
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-27-2017
    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.

    Frequently Asked Questions

    What is NDC 68135-811-02?

    The NDC Packaged Code 68135-811-02 is assigned to a package of 1 kit in 1 carton * 5 ml in 1 vial, glass (68135-500-00) * 5 ml in 1 vial, glass (68135-495-04) of Brineura, a human prescription drug labeled by Biomarin Pharmaceutical Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 68135-811 included in the NDC Directory?

    Yes, Brineura with product code 68135-811 is active and included in the NDC Directory. The product was first marketed by Biomarin Pharmaceutical Inc. on April 27, 2017 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 68135-811-02?

    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 68135-811-02?

    The 11-digit format is 68135081102. 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
    5-3-268135-811-025-4-268135-0811-02