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
BLA	Proprietary name	Proper name	License type	Status	Latest source
125758	Lenmeldy	atidarsagene autotemcel	351(a)	Rx	2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LENMELDY	ATIDARSAGENE AUTOTEMCEL	Orchard Therapeutics (Europe) Ltd	b3e307a7-561b-43b6-a784-9cb1dcfc5196	2026-06-17	Warnings, Adverse reactions	Exact identifier rxcui: 2677926

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
b3e307a7-561b-43b6-a784-9cb1dcfc5196	lenmeldy 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]	3	7	These 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 2024	20250812