FDA.reportPublic FDA data

20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection

RxCUI
2612552
RxNorm name
20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection
Display name
20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection
Full name
20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125755Skysonaelivaldogene autotemcel351(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
SkysonaELIVALDOGENE AUTOTEMCELGenetix Biotherapeutics Inc.f189502b-dc44-4289-99a6-cfba369183292026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2612552

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
f189502b-dc44-4289-99a6-cfba36918329elivaldogene autotemcel 30,000,000 CELLS/mL in 20 ML Injection [PSN] · 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection [SCD] · elivaldogene autotemcel 30,000,000 CELLS/ML per 20 ML Injection [SY]312These highlights do not include all the information needed to use SKYSONA safely and effectively. See full prescribing information for SKYSONA. SKYSONA ® (elivaldogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 202220260407