Danyelza Injection
NDC Package 73042-201-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Danyelza (naxitamab) injection is 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)]. This formulation utilizes a injection delivery system. Marketed by Y-mabs Therapeutics, Inc., this product is identified by NDC 73042-201 and is authorized under FDA application BLA761171.

Identification & Billing

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
11-Digit Billing Format
73042020101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Danyelza
Non-Proprietary Name
Naxitamab
Substance Name
Naxitamab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NAXITAMAB 40 mg/10mL
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Y-mabs Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761171
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-25-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9348
Source: ASP
Inj. naxitamab-gqgk, 1 mg
HCPCS Dosage 1 MG
Units / Pkg 40

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 73042-201-01 identifies a specific commercial 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.. This injection is formulated for intravenous use and contains naxitamab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Y-mabs Therapeutics, Inc. on November 25, 2020. The current certification is valid through December 31, 2026.

How is this Y-mabs Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73042020101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
73042-201-01
11-Digit CMS (5-4-2)
73042-0201-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.