Darzalex Injection, Solution, Concentrate
NDC 57894-502

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 57894-502?
  4. Darzalex Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Darzalex (daratumumab) is a BLA-approved product labeled by Janssen Biotech, Inc.. This medication is used to treat a certain type of cancer (multiple myeloma). It is supplied as a injection, solution, concentrate for intravenous administration. This product entry covers the primary NDC 57894-502 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
57894-502
Proprietary Name:
Darzalex
Non-Proprietary Name: [1]
Daratumumab
Substance Name: [2]
Daratumumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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(s): [4]
Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Janssen Biotech, Inc.
Labeler Code:
57894
Product Label ID:
a4d0efe9-5e54-467e-9eb4-56fa7d53b60b
FDA Application Number: [6]
BLA761036
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
11-16-2015
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 57894-502?

The NDC code 57894-502 is assigned by the FDA to the product Darzalex. It is commonly known by its generic name, daratumumab. This pharmaceutical product is labeled by Janssen Biotech, Inc. and is currently categorized as listed product. The medication is a injection, solution, concentrate administered via intravenous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 57894-502-05, 57894-502-20. 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?

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.

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:

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 Injection


Daratumumab injection is used alone or in combination with other medications 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 is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.
[Learn More]


Cancer Chemotherapy


What is cancer chemotherapy?

Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.

Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.

Chemotherapy is used to:

  • Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
  • Ease cancer symptoms by shrinking tumors that are causing pain and other problems.

What are the side effects of chemotherapy?

Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.

You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.

Some common side effects are:

There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

What can I expect when getting chemotherapy?

You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).

Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.

Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.

NIH: National Cancer Institute


[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".