Home NDC 71287-119 YESCARTA
Product NDC 71287-119
11-digit product format 712870119
Labeler code 71287
Product ID 71287-119_23cad324-9e01-4dba-8152-354dadb7b1e5
Type CELLULAR THERAPY
Nonproprietary name axicabtagene ciloleucel
Dosage form SUSPENSION
Route INTRAVENOUS
Labeler Kite Pharma, Inc.
Application BLA125643
Marketing category BLA
Marketing start 2017-10-18
Substance AXICABTAGENE CILOLEUCEL
Active strength 2000000 1/68mL
Pharmacologic classes CD19 Receptor Interactions [MoA], CD19-directed Chimeric Antigen Receptor [EPC], CD19-specific Chimeric Antigen Receptor [CS], Genetically-modified Autologous T Cells [EPC], Increased T Lymphocyte Activation [PE], T Lymphocytes, Cultured, Autologous, Genetically-modified [EXT]
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 YESCARTA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AXICABTAGENE CILOLEUCEL 2000000 1/68mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U2I8T43Y7R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1987402 Internal RxNorm lookup 1987407 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 71287-119-01 YESCARTA 68 mL in 1 BAG SUSPENSION 68 21 71287-119-02 YESCARTA 1 in 1 PACKAGE SUSPENSION 1 21
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71287-119 YESCARTA (AXICABTAGENE CILOLEUCEL) SUSPENSION [KITE PHARMA, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20241215_9b70606e-b99c-4272-a0f1-b5523cce0c59.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 YESCARTA AXICABTAGENE CILOLEUCEL Kite Pharma, Inc. 9b70606e-b99c-4272-a0f1-b5523cce0c59 2026-08-06 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125643 ndc (product): 71287-119
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125643 Yescarta axicabtagene ciloleucel 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1987402 axicabtagene ciloleucel 200,000,000 CELLS in 68 mL Injection PSN 9b70606e-b99c-4272-a0f1-b5523cce0c59 21 1987407 YESCARTA 200,000,000 CELLS in 68 mL Injection PSN 9b70606e-b99c-4272-a0f1-b5523cce0c59 21 1987407 68 ML axicabtagene ciloleucel 2940000 CELLS/ML Injection [Yescarta] SBD 9b70606e-b99c-4272-a0f1-b5523cce0c59 21 1987402 68 ML axicabtagene ciloleucel 2940000 CELLS/ML Injection SCD 9b70606e-b99c-4272-a0f1-b5523cce0c59 21 1987407 68 ML Yescarta 2940000 CELLS/ML Injection SY 9b70606e-b99c-4272-a0f1-b5523cce0c59 21 1987402 axicabtagene ciloleucel 200,000,000 CELLS per 68 ML Injection SY 9b70606e-b99c-4272-a0f1-b5523cce0c59 21 1987407 Yescarta 200,000,000 CELLS per 68 ML Injection SY 9b70606e-b99c-4272-a0f1-b5523cce0c59 21
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71287-119-01 71287011901 68 mL in 1 BAG 68 ml Historical 71287-119-02 71287011902 1 BAG in 1 PACKAGE (71287-119-02) / 68 mL in 1 BAG (71287-119-01) 1 bag 2017-10-18 0000-00-00 No No Current