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)Rx2026-06-01

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#

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkysonaELIVALDOGENE AUTOTEMCELGenetix Biotherapeutics Inc.f189502b-dc44-4289-99a6-cfba369183292026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2612552

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f189502b-dc44-4289-99a6-cfba3691832920 ML elivaldogene autotemcel 30000000 CELLS/ML InjectionSCD12These 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
f189502b-dc44-4289-99a6-cfba36918329elivaldogene autotemcel 30,000,000 CELLS/ML per 20 ML InjectionSY12These 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
f189502b-dc44-4289-99a6-cfba36918329elivaldogene autotemcel 30,000,000 CELLS/mL in 20 ML InjectionPSN12These 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