Home NDC 71287-119 YESCARTA
Product NDC 71287-119
11-digit product format 712870119
Labeler code 71287
Product ID 71287-119_218926d3-232d-4c27-b42b-8421e7d70d86
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 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 YESCARTA AXICABTAGENE CILOLEUCEL Kite Pharma, Inc. 9b70606e-b99c-4272-a0f1-b5523cce0c59 2026-06-15 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125643 ndc (product): 71287-119
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
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 2026-06-01
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