Home NDC 71287-219 TECARTUS
Product NDC 71287-219
11-digit product format 712870219
Labeler code 71287
Product ID 71287-219_17c4a716-a22e-486d-b633-4be6c2453266
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
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 2026-09-01
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