Darzalex Iv Injection, Solution, Concentrate
NDC Package 57894-505-20
Package Information
Darzalex Iv (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 57894-505 and is authorized under FDA application BLA761036.
Identification & Billing
- 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]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 57894 - Janssen Biotech, Inc.
- 57894-505 - Darzalex Iv
- 57894-505-20 - 1 VIAL, SINGLE-DOSE in 1 BOX / 20 mL in 1 VIAL, SINGLE-DOSE
- 57894-505 - Darzalex Iv
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 (57894-505). Click a package code to view its specific billing and regulatory data.
* 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 57894-505-20 identifies a specific commercial package of 1 vial, single-dose in 1 box / 20 ml in 1 vial, single-dose of Darzalex Iv, 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 October 15, 2021. 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: 57894050520. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
