FDA.reportPublic FDA data

atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML Injection

RxCUI
2677920
RxNorm name
atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML Injection
Display name
atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML Injection
Full name
atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125758Lenmeldyatidarsagene autotemcel351(a)Rx2026-10-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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
b3e307a7-561b-43b6-a784-9cb1dcfc5196atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML Injection [PSN] · 10 ML atidarsagene autotemcel 11800000 CELLS/ML Injection [SCD] · atidarsagene autotemcel 11,800,000 CELLS/ML per 10 ML Injection [SY]37These highlights do not include all the information needed to use LENMELDY safely and effectively. See full prescribing information for LENMELDY. LENMELDY (atidarsagene autotemcel) suspension for intravenous infusion Initial U.S. Approval 202420250812