Home NDC 73153-900 BREYANZI
Product NDC 73153-900
11-digit product format 731530900
Labeler code 73153
Product ID 73153-900_6e83a5e5-a286-42e0-b22b-7d5f0b2cb920
Type CELLULAR THERAPY
Nonproprietary name Lisocabtagene maraleucel
Dosage form KIT
Labeler Juno Therapeutics, Inc.
Application BLA125714
Marketing category BLA
Marketing start 2021-02-05
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 BREYANZI
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2479140 Internal RxNorm lookup 2479145 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 73153-900-01 BREYANZI 1 in 1 CARTON KIT 1 15 73153-901-08 BREYANZI 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 5 mL 50000000 in 5mL 15 73153-902-04 BREYANZI 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 5 mL 50000000 in 5mL 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73153-900 BREYANZI (LISOCABTAGENE MARALEUCEL) KIT [JUNO THERAPEUTICS, INC.] 12 Current NDC, Legacy NDC, 3 package rows 20240612_594bb413-af3b-4b97-afb3-bfe2b174f2ed.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 BREYANZI LISOCABTAGENE MARALEUCEL Juno Therapeutics, Inc. 594bb413-af3b-4b97-afb3-bfe2b174f2ed 2026-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125714 ndc (product): 73153-900
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125714 Breyanzi lisocabtagene maraleucel 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2479145 Breyanzi 70,000,000 CELLS/mL in 4.6 mL Injection PSN 594bb413-af3b-4b97-afb3-bfe2b174f2ed 15 2479140 lisocabtagene maraleucel 70,000,000 CELLS/mL in 4.6 mL Injection PSN 594bb413-af3b-4b97-afb3-bfe2b174f2ed 15 2479145 4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML Injection [Breyanzi] SBD 594bb413-af3b-4b97-afb3-bfe2b174f2ed 15 2479140 4.6 ML lisocabtagene maraleucel 70000000 CELLS/ML Injection SCD 594bb413-af3b-4b97-afb3-bfe2b174f2ed 15 2479145 4.6 ML Breyanzi 70,000,000 CELLS/ML Injection SY 594bb413-af3b-4b97-afb3-bfe2b174f2ed 15 2479145 Breyanzi 70,000,000 CELLS/ML per 4.6 ML Injection SY 594bb413-af3b-4b97-afb3-bfe2b174f2ed 15 2479140 lisocabtagene maraleucel 70,000,000 CELLS/ML per 4.6 ML Injection SY 594bb413-af3b-4b97-afb3-bfe2b174f2ed 15
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73153-900-01 73153090001 1 KIT in 1 CARTON (73153-900-01) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-902-04) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-901-08) 1 kit 2021-02-05 0000-00-00 No No Current 73153-901-08 73153090108 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 73153-902-04 73153090204 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical