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)Rx2026-06-01

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
LENMELDYATIDARSAGENE AUTOTEMCELOrchard Therapeutics (Europe) Ltdb3e307a7-561b-43b6-a784-9cb1dcfc51962026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 2677920

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b3e307a7-561b-43b6-a784-9cb1dcfc5196atidarsagene autotemcel 11,800,000 CELLS/ML in 10 ML InjectionPSN7These 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
b3e307a7-561b-43b6-a784-9cb1dcfc5196atidarsagene autotemcel 11,800,000 CELLS/ML per 10 ML InjectionSY7These 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
b3e307a7-561b-43b6-a784-9cb1dcfc519610 ML atidarsagene autotemcel 11800000 CELLS/ML InjectionSCD7These 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