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  5. NDC Package Code: 73042-201-01 Danyelza

NDC Package 73042-201-01 Danyelza

Naxitamab Injection Intravenous - 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:
73042-201-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code:
73042-201
Proprietary Name:
Danyelza
Non-Proprietary Name:
Naxitamab
Substance Name:
Naxitamab
Usage Information:
DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
11-Digit NDC Billing Format:
73042020101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2474239 - naxitamab-gqgk 40 MG per 10 ML Injection
  • RxCUI: 2474239 - 10 ML naxitamab-gqgk 4 MG/ML Injection
  • RxCUI: 2474244 - DANYELZA 40 MG in 10 ML Injection
  • RxCUI: 2474244 - 10 ML naxitamab-gqgk 4 MG/ML Injection [Danyelza]
  • RxCUI: 2474244 - 10 ML Danyelza 4 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Y-mabs Therapeutics, 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):
  • NAXITAMAB 40 mg/10mL
    • Pharmacologic Class(es):
  • Glycolipid Disialoganglioside-directed Antibody Interactions - [MoA] (Mechanism of Action)
  • Glycolipid Disialoganglioside-directed Antibody - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA761171
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-25-2020
    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.

    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 73042-201-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    73042020101J9348Inj. naxitamab-gqgk, 1 mg1 MG1014040

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 73042-201-01?

    The NDC Packaged Code 73042-201-01 is assigned to a package of 1 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose of Danyelza, a human prescription drug labeled by Y-mabs Therapeutics, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 73042-201 included in the NDC Directory?

    Yes, Danyelza with product code 73042-201 is active and included in the NDC Directory. The product was first marketed by Y-mabs Therapeutics, Inc. on November 25, 2020 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 73042-201-01?

    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 73042-201-01?

    The 11-digit format is 73042020101. 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
    5-3-273042-201-015-4-273042-0201-01