1. Home
  2. Labeler Index
  3. Ultragenyx Pharmaceutical Inc.
  4. 69794-001
  5. NDC Package Code: 69794-001-01 Mepsevii

NDC Package 69794-001-01 Mepsevii

Vestronidase Alfa Injection Intravenous - 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:
69794-001-01
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-USE
Product Code:
69794-001
Proprietary Name:
Mepsevii
Non-Proprietary Name:
Vestronidase Alfa
Substance Name:
Vestronidase Alfa
Usage Information:
MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome). Limitations of UseThe effect of MEPSEVII on the central nervous system manifestations of MPS VII has not been determined.
11-Digit NDC Billing Format:
69794000101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1989823 - vestronidase alfa-vjbk 10 MG in 5 ML Injection
  • RxCUI: 1989823 - 5 ML vestronidase alfa-vjbk 2 MG/ML Injection
  • RxCUI: 1989823 - vestronidase alfa-vjbk 10 MG per 5 ML Injection
  • RxCUI: 1989828 - Mepsevii 10 MG in 5 ML Injection
  • RxCUI: 1989828 - 5 ML vestronidase alfa-vjbk 2 MG/ML Injection [Mepsevii]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ultragenyx Pharmaceutical Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • VESTRONIDASE ALFA 2 mg/mL
    • Pharmacologic Class(es):
  • Lysosomal beta Glucuronidase - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA761047
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-15-2017
    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 69794-001-01?

    The NDC Packaged Code 69794-001-01 is assigned to a package of 1 vial, single-use in 1 carton / 5 ml in 1 vial, single-use of Mepsevii, a human prescription drug labeled by Ultragenyx Pharmaceutical Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 69794-001 included in the NDC Directory?

    Yes, Mepsevii with product code 69794-001 is active and included in the NDC Directory. The product was first marketed by Ultragenyx Pharmaceutical Inc. on November 15, 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 69794-001-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 69794-001-01?

    The 11-digit format is 69794000101. 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
    5-3-269794-001-015-4-269794-0001-01