FDA.reportPublic FDA data

donislecel-jujn 400 ML Injection

RxCUI
2642264
RxNorm name
donislecel-jujn 400 ML Injection
Display name
donislecel-jujn 400 ML Injection
Full name
donislecel-jujn 400 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125734Lantidradonislecel-jujn351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LANTIDRADONISLECELCellTrans Inc.24610d9f-0c5a-4f55-93b3-d456300bfd5d2026-01-13Warnings, Adverse reactionsExact identifier
rxcui: 2642264

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
24610d9f-0c5a-4f55-93b3-d456300bfd5ddonislecel-jujn 400 ML Injection [PSN] · 400 ML donislecel-jujn 2500 EIN/ML Injection [SCD] · donislecel-jujn 400 ML Injection [SY]33These highlights do not include all the information needed to use LANTIDRA safely and effectively. See full prescribing information for LANTIDRA. LANTIDRA (donislecel-jujn) Suspension for hepatic portal vein infusion Initial U.S. Approval: 202320260113