NDC Package 71287-219-02 Tecartus

Brexucabtagene Autoleucel Suspension Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
71287-219-02
Package Description:
1 BAG in 1 PACKAGE / 68 mL in 1 BAG (71287-219-01)
Product Code:
Proprietary Name:
Tecartus
Non-Proprietary Name:
Brexucabtagene Autoleucel
Substance Name:
Brexucabtagene Autoleucel
Usage Information:
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.
11-Digit NDC Billing Format:
71287021902
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • 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]
  • Product Type:
    Cellular Therapy
    Labeler Name:
    Kite Pharma, Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Sample Package:
    No
    FDA Application Number:
    BLA125703
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    07-24-2020
    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.

    Frequently Asked Questions

    What is NDC 71287-219-02?

    The NDC Packaged Code 71287-219-02 is assigned to a package of 1 bag in 1 package / 68 ml in 1 bag (71287-219-01) of Tecartus, a cellular therapy labeled by Kite Pharma, Inc.. The product's dosage form is suspension and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 71287-219 included in the NDC Directory?

    Yes, Tecartus with product code 71287-219 is active and included in the NDC Directory. The product was first marketed by Kite Pharma, Inc. on July 24, 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 71287-219-02?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 71287-219-02?

    The 11-digit format is 71287021902. 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
    5-3-271287-219-025-4-271287-0219-02