NDC 57894-111 Carvykti

Ciltacabtagene Autoleucel Injection, Suspension Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
57894-111
Proprietary Name:
Carvykti
Non-Proprietary Name: [1]
Ciltacabtagene Autoleucel
Substance Name: [2]
Ciltacabtagene Autoleucel
NDC Directory Status:
Cellular Therapy
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Janssen Biotech, Inc
    Labeler Code:
    57894
    FDA Application Number: [6]
    BLA125746
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    02-28-2022
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 57894-111-01

    Package Description: 1 INJECTION, SUSPENSION in 1 BAG

    NDC Code 57894-111-02

    Package Description: 1 INJECTION, SUSPENSION in 1 BAG

    Product Details

    What is NDC 57894-111?

    The NDC code 57894-111 is assigned by the FDA to the product Carvykti which is a cellular therapy product labeled by Janssen Biotech, Inc. The generic name of Carvykti is ciltacabtagene autoleucel. The product's dosage form is injection, suspension and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 57894-111-01 1 injection, suspension in 1 bag , 57894-111-02 1 injection, suspension in 1 bag . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Carvykti?

    CARVYKTI is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

    What are Carvykti Active Ingredients?

    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 Carvykti UNII Codes?

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

    • CILTACABTAGENE AUTOLEUCEL (UNII: 0L1F17908Q)
    • CILTACABTAGENE AUTOLEUCEL (UNII: 0L1F17908Q) (Active Moiety)

    Which are Carvykti Inactive Ingredients 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 Carvykti?

    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: 2594780 - ciltacabtagene autoleucel 100,000,000 CELLS in 70 ML Injection
    • RxCUI: 2594780 - 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection
    • RxCUI: 2594780 - ciltacabtagene autoleucel 100,000,000 CELLS per 70 ML Injection
    • RxCUI: 2594786 - CARVYKTI 100,000,000 CELLS in 70 ML Injection
    • RxCUI: 2594786 - 70 ML ciltacabtagene autoleucel 1430000 CELLS/ML Injection [Carvykti]

    * Please review the disclaimer below.

    Patient Education

    Ciltacabtagene Autoleucel Injection


    Ciltacabtagene autoleucel is used to treat multiple myeloma (a type of cancer of the bone marrow) in adults that has returned or that did not respond to at least 4 other treatments. Ciltacabtagene autoleucel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".