NDC Package 57894-505-05 Darzalex Iv

Daratumumab Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
57894-505-05
Package Description:
1 VIAL, SINGLE-DOSE in 1 BOX / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code:
Proprietary Name:
Darzalex Iv
Non-Proprietary Name:
Daratumumab
Substance Name:
Daratumumab
Usage Information:
This medication is used to treat a certain type of cancer (multiple myeloma). Daratumumab belongs to a class of drugs known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells.
11-Digit NDC Billing Format:
57894050505
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1721951 - daratumumab 100 MG in 5 ML Injection
  • RxCUI: 1721951 - 5 ML daratumumab 20 MG/ML Injection
  • RxCUI: 1721951 - daratumumab 100 MG per 5 ML Injection
  • RxCUI: 1721956 - DARZALEX 100 MG in 5 ML Injection
  • RxCUI: 1721956 - 5 ML daratumumab 20 MG/ML Injection [Darzalex]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Biotech, Inc.
    Dosage Form:
    Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    BLA761036
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-15-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    57894-505-201 VIAL, SINGLE-DOSE in 1 BOX / 20 mL in 1 VIAL, SINGLE-DOSE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57894-505-05?

    The NDC Packaged Code 57894-505-05 is assigned to a package of 1 vial, single-dose in 1 box / 5 ml in 1 vial, single-dose of Darzalex Iv, a human prescription drug labeled by Janssen Biotech, Inc.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

    Is NDC 57894-505 included in the NDC Directory?

    Yes, Darzalex Iv with product code 57894-505 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on October 15, 2021 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 57894-505-05?

    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 57894-505-05?

    The 11-digit format is 57894050505. 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
    5-3-257894-505-055-4-257894-0505-05