Darzalex Faspro Injection
NDC 57894-503

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57894-503?
  5. Darzalex Faspro Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Darzalex Faspro (daratumumab and hyaluronidase-fihj (human recombinant)) is a BLA-approved product labeled by Janssen Biotech, Inc.. This medication is typically used as a antibodies. It is supplied as a yellow injection for subcutaneous administration. This product entry covers the primary NDC 57894-503 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
57894-503
Proprietary Name:
Darzalex Faspro
Non-Proprietary Name: [1]
Daratumumab And Hyaluronidase-fihj (human Recombinant)
Substance Name: [2]
Daratumumab; Hyaluronidase (human Recombinant)
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Janssen Biotech, Inc.
Labeler Code:
57894
Product Label ID:
4bb241af-4299-4373-8762-2d6709515db0
HCPCS Code:
J9144 - Daratumumab, hyaluronidase
FDA Application Number: [6]
BLA761145
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
05-01-2020
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
YELLOW (C48330 - COLORLESS TO YELLOW)

Code Structure Chart

Product Details

What is NDC 57894-503?

The NDC code 57894-503 is assigned by the FDA to the product Darzalex Faspro. It is commonly known by its generic name, daratumumab and hyaluronidase-fihj (human recombinant). This pharmaceutical product is labeled by Janssen Biotech, Inc. and is currently categorized as listed product. The medication is a injection administered via subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 57894-503-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Daratumumab and Hyaluronidase-fihj Injection


Daratumumab and hyaluronidase-fihj injection is used alone or in combination with other medications or treatments to treat multiple myeloma (a type of cancer of the bone marrow) in newly diagnosed people and in people who have not improved with treatment or who have improved after treatment with other medications but the condition returned. Daratumumab and hyaluronidase-fihj injection is also used in combination with other medications to treat a certain kind of amyloidosis (a disease in which abnormal proteins build up in tissues and organs in the body) in newly diagnosed adults. Daratumumab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Hyaluronidase-fihj is an endoglycosidase. It helps to keep daratumumab in the body longer so that the medication will have a greater effect.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".