FDA.reportPublic FDA data

Lenmeldy 11,800,000 CELLS/ML per 10 ML Injection

RxCUI
2677926
RxNorm name
Lenmeldy 11,800,000 CELLS/ML per 10 ML Injection
Display name
Lenmeldy 11,800,000 CELLS/ML per 10 ML Injection
Full name
Lenmeldy 11,800,000 CELLS/ML per 10 ML Injection
Term type
SY
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-a784-9cb1dcfc5196lenmeldy 11,800,000 CELLS/ML in 10 ML Injection [PSN] · 10 ML atidarsagene autotemcel 11800000 CELLS/ML Injection [Lenmeldy] [SBD] · Lenmeldy 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