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	2026-06-01

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
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

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
b3e307a7-561b-43b6-a784-9cb1dcfc5196	Lenmeldy 11,800,000 CELLS/ML per 10 ML Injection	SY	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
b3e307a7-561b-43b6-a784-9cb1dcfc5196	10 ML atidarsagene autotemcel 11800000 CELLS/ML Injection [Lenmeldy]	SBD	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
b3e307a7-561b-43b6-a784-9cb1dcfc5196	lenmeldy 11,800,000 CELLS/ML in 10 ML Injection	PSN	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