Darzalex Faspro Injection
NDC Package 57894-503-01

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

Package Information

Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) injection is dARZALEX FASPRO is indicated for the treatment of adult patients with multiple myeloma:in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. This formulation utilizes a injection delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-503 and is authorized under FDA application BLA761145.

Identification & Billing

NDC Package Code
57894-503-01
Package Description
1 VIAL, SINGLE-DOSE in 1 BOX / 15 mL in 1 VIAL, SINGLE-DOSE
Product Code
57894-503
11-Digit Billing Format
57894050301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Darzalex Faspro
Non-Proprietary Name
Daratumumab And Hyaluronidase-fihj (human Recombinant)
Substance Name
Daratumumab; Hyaluronidase (human Recombinant)
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
DARZALEX FASPRO is indicated for the treatment of adult patients with multiple myeloma:in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761145
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-01-2020
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.

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.

J9144
Source: ASP
Daratumumab, hyaluronidase
HCPCS Dosage 10 MG
Units / Pkg 180

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57894-503-01 identifies a specific commercial package of 1 vial, single-dose in 1 box / 15 ml in 1 vial, single-dose of Darzalex Faspro, a human prescription drug labeled by Janssen Biotech, Inc.. This injection is formulated for subcutaneous use and contains daratumumab; hyaluronidase (human recombinant) 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 May 01, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894050301. 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)
57894-503-01
11-Digit CMS (5-4-2)
57894-0503-01

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