Danyelza Injection
NDC Package 50633-230-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Btg International Inc., this product is identified by NDC 50633-230 and is authorized under FDA application BLA761171.

Identification & Billing

NDC Package Code
50633-230-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
Product Code
50633-230
11-Digit Billing Format
50633023001
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
Btg International Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761171
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-01-2026
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50633-230-01 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 Btg International 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 Btg International Inc. on September 01, 2026. The current certification is valid through December 31, 2027.

How is this Btg International Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50633023001. 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)
50633-230-01
11-Digit CMS (5-4-2)
50633-0230-01

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