Home NDC 71287-219 TECARTUS
Product NDC 71287-219
11-digit product format 712870219
Labeler code 71287
Product ID 71287-219_16fbe9a0-d7d4-43b1-aa67-3c16ff8c5f55
Type CELLULAR THERAPY
Nonproprietary name brexucabtagene autoleucel
Dosage form SUSPENSION
Route INTRAVENOUS
Labeler Kite Pharma, Inc.
Application BLA125703
Marketing category BLA
Marketing start 2020-07-24
Substance BREXUCABTAGENE AUTOLEUCEL
Active strength 2000000 1/68mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TECARTUS BREXUCABTAGENE AUTOLEUCEL Kite Pharma, Inc. a16108c2-7ca7-45af-965e-54bda4713022 2026-06-16 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125703 ndc (product): 71287-219
Additional Listing Data#
Finished product Yes
Brand name base TECARTUS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BREXUCABTAGENE AUTOLEUCEL 2000000 1/68mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4MD2J2T8SJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387347 Internal RxNorm lookup 2387352 Internal RxNorm lookup 2572002 Internal RxNorm lookup 2572005 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71287-219-01 TECARTUS 68 mL in 1 BAG SUSPENSION 68 16 71287-219-02 TECARTUS 1 in 1 PACKAGE SUSPENSION 1 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71287-219 TECARTUS (BREXUCABTAGENE AUTOLEUCEL) SUSPENSION [KITE PHARMA, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20240627_a16108c2-7ca7-45af-965e-54bda4713022.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125703 Tecartus Brexucabtagene Autoleucel 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2572002 brexucabtagene autoleucel 100,000,000 CELLS per 68 ML Injection PSN a16108c2-7ca7-45af-965e-54bda4713022 16 2387347 brexucabtagene autoleucel 200,000,000 CELLS in 68 ML Injection PSN a16108c2-7ca7-45af-965e-54bda4713022 16 2572005 Tecartus 100,000,000 CELLS in 68 ML Injection PSN a16108c2-7ca7-45af-965e-54bda4713022 16 2387352 Tecartus 200,000,000 CELLS in 68 ML Injection PSN a16108c2-7ca7-45af-965e-54bda4713022 16 2572005 68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection [Tecartus] SBD a16108c2-7ca7-45af-965e-54bda4713022 16 2387352 68 ML brexucabtagene autoleucel 2940000 CELLS/ML Injection [Tecartus] SBD a16108c2-7ca7-45af-965e-54bda4713022 16 2572002 68 ML brexucabtagene autoleucel 1471000 CELLS/ML Injection SCD a16108c2-7ca7-45af-965e-54bda4713022 16 2387347 68 ML brexucabtagene autoleucel 2940000 CELLS/ML Injection SCD a16108c2-7ca7-45af-965e-54bda4713022 16 2572005 68 ML Tecartus 1471000 CELLS/ML Injection SY a16108c2-7ca7-45af-965e-54bda4713022 16 2387352 68 ML Tecartus 2940000 CELLS/ML Injection SY a16108c2-7ca7-45af-965e-54bda4713022 16 2572002 brexucabtagene autoleucel 100,000,000 CELLS per 68 ML Injection SY a16108c2-7ca7-45af-965e-54bda4713022 16 2387347 brexucabtagene autoleucel 200,000,000 CELLS per 68 ML Injection SY a16108c2-7ca7-45af-965e-54bda4713022 16 2572005 Tecartus 100,000,000 CELLS per 68 ML Injection SY a16108c2-7ca7-45af-965e-54bda4713022 16 2387352 Tecartus 200,000,000 CELLS per 68 ML Injection SY a16108c2-7ca7-45af-965e-54bda4713022 16
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71287-219-01 71287021901 68 mL in 1 BAG 68 ml Historical 71287-219-02 71287021902 1 BAG in 1 PACKAGE (71287-219-02) / 68 mL in 1 BAG (71287-219-01) 1 bag 2020-07-24 0000-00-00 No No Current