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  5. NDC Package Code: 66302-014-01 Unituxin

NDC Package 66302-014-01 Unituxin

Dinutuximab Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
66302-014-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
66302-014
Proprietary Name:
Unituxin
Non-Proprietary Name:
Dinutuximab
Substance Name:
Dinutuximab
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)].
11-Digit NDC Billing Format:
66302001401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1606278 - dinutuximab 17.5 MG in 5 ML Injection
  • RxCUI: 1606278 - 5 ML dinutuximab 3.5 MG/ML Injection
  • RxCUI: 1606278 - dinutuximab 17.5 MG per 5 ML Injection
  • RxCUI: 1606283 - Unituxin 17.5 MG in 5 ML Injection
  • RxCUI: 1606283 - 5 ML dinutuximab 3.5 MG/ML Injection [Unituxin]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    United Therapeutics Corporation
    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):
  • DINUTUXIMAB 3.5 mg/mL
    • 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:
    BLA125516
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-10-2015
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 66302-014-01?

    The NDC Packaged Code 66302-014-01 is assigned to a 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. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 66302-014 included in the NDC Directory?

    Yes, Unituxin with product code 66302-014 is active and included in the NDC Directory. The product was first marketed by United Therapeutics Corporation on March 10, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 66302-014-01?

    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 66302-014-01?

    The 11-digit format is 66302001401. 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
    5-3-266302-014-015-4-266302-0014-01