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  5. NDC Package Code: 57894-503-01 Darzalex Faspro

NDC Package 57894-503-01 Darzalex Faspro

Daratumumab And Hyaluronidase-fihj (human Recombinant) Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
57894-503-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 BOX / 15 mL in 1 VIAL, SINGLE-DOSE
Product Code:
57894-503
Proprietary Name:
Darzalex Faspro
Non-Proprietary Name:
Daratumumab And Hyaluronidase-fihj (human Recombinant)
Substance Name:
Daratumumab; Hyaluronidase (human Recombinant)
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.
11-Digit NDC Billing Format:
57894050301
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2375136 - daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT in 15 mL Injection
  • RxCUI: 2375136 - 15 ML daratumumab-fihj 120 MG/ML / hyaluronidase-fihj 2000 UNT/ML Injection
  • RxCUI: 2375136 - daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT per 15 mL Injection
  • RxCUI: 2375141 - DARZALEX Faspro 1800 MG / 30,000 UNT in 15 mL Injection
  • RxCUI: 2375141 - 15 ML daratumumab-fihj 120 MG/ML / hyaluronidase-fihj 2000 UNT/ML Injection [Darzalex Faspro]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Biotech, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • DARATUMUMAB 1800 mg/15mL
  • HYALURONIDASE (HUMAN RECOMBINANT) 30000 U/15mL
    • Pharmacologic Class(es):
  • Antibodies, Monoclonal - [CS]
  • CD38-directed Antibody Interactions - [MoA] (Mechanism of Action)
  • CD38-directed Cytolytic Antibody - [EPC] (Established Pharmacologic Class)
  • Endoglycosidase - [EPC] (Established Pharmacologic Class)
  • Glycoside Hydrolases - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA761145
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    05-01-2020
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 57894-503-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    57894050301J9144Daratumumab, hyaluronidase10 MG151180180

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57894-503-01?

    The NDC Packaged Code 57894-503-01 is assigned to a 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.. The product's dosage form is injection and is administered via subcutaneous form.

    Is NDC 57894-503 included in the NDC Directory?

    Yes, Darzalex Faspro with product code 57894-503 is active and included in the NDC Directory. The product was first marketed by Janssen Biotech, Inc. on May 01, 2020 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 57894-503-01?

    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 57894-503-01?

    The 11-digit format is 57894050301. 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
    5-3-257894-503-015-4-257894-0503-01