Tecartus Suspension
NDC Package 71287-220-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tecartus (brexucabtagene autoleucel) suspension is 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)]. This formulation utilizes a suspension delivery system. Marketed by Kite Pharma, Inc., this product is identified by NDC 71287-220 and is authorized under FDA application BLA125703.

Identification & Billing

NDC Package Code
71287-220-02
Package Description
1 BAG in 1 PACKAGE / 68 mL in 1 BAG (71287-220-01)
Product Code
71287-220
11-Digit Billing Format
71287022002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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]

Clinical Specifications

Proprietary Name
Tecartus
Non-Proprietary Name
Brexucabtagene Autoleucel
Substance Name
Brexucabtagene Autoleucel
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BREXUCABTAGENE AUTOLEUCEL 1000000 1/68mL
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.

Regulatory & Marketing

Labeler Name
Kite Pharma, Inc.
Product Type
Cellular Therapy
FDA Application #
BLA125703
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-01-2021
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71287-220-02 identifies a specific commercial package of 1 bag in 1 package / 68 ml in 1 bag (71287-220-01) of Tecartus, a cellular therapy labeled by Kite Pharma, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This suspension is formulated for intravenous use and contains brexucabtagene autoleucel as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kite Pharma, Inc. on October 01, 2021. The current certification is valid through December 31, 2027.

How is this Kite Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71287022002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
71287-220-02
11-Digit CMS (5-4-2)
71287-0220-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.