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  4. NDC Product Code: 71287-220 Tecartus

NDC 71287-220 Tecartus

Brexucabtagene Autoleucel Suspension Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 71287-220?
  4. Tecartus Uses
  5. Active Ingredients
  6. NDC to RxNorm Crosswalk
  7. Patient Education

Product Information

NDC Product Code:
71287-220
Proprietary Name:
Tecartus
Non-Proprietary Name: [1]
Brexucabtagene Autoleucel
Substance Name: [2]
Brexucabtagene Autoleucel
NDC Directory Status:
Cellular Therapy
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Kite Pharma, Inc.
    Labeler Code:
    71287
    Product Label ID:
    a16108c2-7ca7-45af-965e-54bda4713022
    FDA Application Number: [6]
    BLA125703
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    10-01-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 71287-220-02

    Package Description: 1 BAG in 1 PACKAGE / 68 mL in 1 BAG (71287-220-01)

    Product Details

    What is NDC 71287-220?

    The NDC code 71287-220 is assigned by the FDA to the product Tecartus which is a cellular therapy product labeled by Kite Pharma, Inc.. The generic name of Tecartus is brexucabtagene autoleucel. The product's dosage form is suspension and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 71287-220-02 1 bag in 1 package / 68 ml in 1 bag (71287-220-01). 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 Tecartus?

    TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).This indication is approved under accelerated approval based on overall response rate and durability of response[see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

    What are Tecartus 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.

    What is the NDC to RxNorm Crosswalk for Tecartus?

    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: 2387347 - brexucabtagene autoleucel 200,000,000 CELLS in 68 ML Injection
    • RxCUI: 2387347 - 68 ML brexucabtagene autoleucel 2940000 CELLS/ML Injection
    • RxCUI: 2387347 - brexucabtagene autoleucel 200,000,000 CELLS per 68 ML Injection
    • RxCUI: 2387352 - Tecartus 200,000,000 CELLS in 68 ML Injection
    • RxCUI: 2387352 - 68 ML brexucabtagene autoleucel 2940000 CELLS/ML Injection [Tecartus]

    * Please review the disclaimer below.

    Patient Education

    Brexucabtagene Autoleucel Injection


    Brexucabtagene autoleucel is used to treat mantle cell lymphoma (a fast-growing cancer that begins in the cells of the immune system) in adults that has returned or is unresponsive to other treatment(s). Brexucabtagene autoleucel is also used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in adults that has returned or is unresponsive to other treatment(s). Brexucabtagene autoleucel injection 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".