Darzalex Injection, Solution, Concentrate
NDC Package 57894-502-20

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

Package Information

Darzalex (daratumumab) injection is a medication used to treat a certain type of cancer (multiple myeloma). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-502 and is authorized under FDA application BLA761036.

Identification & Billing

NDC Package Code
57894-502-20
Package Description
1 VIAL in 1 CARTON / 20 mL in 1 VIAL
Product Code
57894-502
11-Digit Billing Format
57894050220
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Darzalex
Non-Proprietary Name
Daratumumab
Substance Name
Daratumumab
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DARATUMUMAB 100 mg/5mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761036
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-16-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57894-502). Click a package code to view its specific billing and regulatory data.

57894-502-05
1 VIAL in 1 CARTON / 5 mL in 1 VIAL

* 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 57894-502-20 identifies a specific commercial package of 1 vial in 1 carton / 20 ml in 1 vial of Darzalex, a human prescription drug labeled by Janssen Biotech, Inc.. This injection, solution, concentrate is formulated for intravenous use and contains daratumumab 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 Janssen Biotech, Inc. on November 16, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Janssen Biotech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894050220. 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)
57894-502-20
11-Digit CMS (5-4-2)
57894-0502-20

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