1. Labeler Index
  2. Ultragenyx Pharmaceutical Inc.
  3. 69794-102
  4. NDC Package Code: 69794-102-01 Crysvita

NDC Package 69794-102-01 Crysvita

Burosumab Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
69794-102-01
Package Description:
1 mL in 1 VIAL, SINGLE-USE
Product Code:
69794-102
Proprietary Name:
Crysvita
Non-Proprietary Name:
Burosumab
Substance Name:
Burosumab
Usage Information:
CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.
11-Digit NDC Billing Format:
69794010201
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
1 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 2043859 - burosumab-twza 10 MG in 1 ML Injection
  • RxCUI: 2043859 - 1 ML burosumab-twza 10 MG/ML Injection
  • RxCUI: 2043859 - burosumab-twza 10 MG per 1 ML Injection
  • RxCUI: 2043864 - CRYSViTA 10 MG in 1 ML Injection
  • RxCUI: 2043864 - 1 ML burosumab-twza 10 MG/ML Injection [Crysvita]
    • 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):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • BUROSUMAB 10 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    BLA761068
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-18-2018
    Listing Expiration Date:
    12-31-2023
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 69794-102-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    69794010201J0584Injection, burosumab-twza 1m1 MG111010

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69794-102-01?

    The NDC Packaged Code 69794-102-01 is assigned to a package of 1 ml in 1 vial, single-use of Crysvita, a human prescription drug labeled by Ultragenyx Pharmaceutical Inc.. The product's dosage form is injection and is administered via subcutaneous form.This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package.

    Is NDC 69794-102 included in the NDC Directory?

    Yes, Crysvita with product code 69794-102 is active and included in the NDC Directory. The product was first marketed by Ultragenyx Pharmaceutical Inc. on April 18, 2018 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 69794-102-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 69794-102-01?

    The 11-digit format is 69794010201. 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
    5-3-269794-102-015-4-269794-0102-01