Unituxin Injection
NDC Package 66302-014-01

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

Package Information

Unituxin (dinutuximab) injection is unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14)]. This formulation utilizes a injection delivery system. Marketed by United Therapeutics Corporation, this product is identified by NDC 66302-014 and is authorized under FDA application BLA125516.

Identification & Billing

NDC Package Code
66302-014-01
Package Description
1 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
66302-014
11-Digit Billing Format
66302001401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Unituxin
Non-Proprietary Name
Dinutuximab
Substance Name
Dinutuximab
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)
DINUTUXIMAB 3.5 mg/mL
Pharmacologic Class
Usage Information
Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
United Therapeutics Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA125516
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-10-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66302-014-01 identifies a specific commercial package of 1 vial, single-dose in 1 box / 5 ml in 1 vial, single-dose of Unituxin, a human prescription drug labeled by United Therapeutics Corporation. This injection is formulated for intravenous use and contains dinutuximab 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 United Therapeutics Corporation on March 10, 2015. The current certification is valid through December 31, 2026.

How is this United Therapeutics Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66302001401. 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)
66302-014-01
11-Digit CMS (5-4-2)
66302-0014-01

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