FDA.reportPublic FDA data

20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection [Lyfgenia]

RxCUI
2672697
RxNorm name
20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection [Lyfgenia]
Display name
20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection [Lyfgenia]
Full name
20 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection [Lyfgenia]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125788LYFGENIAlovotibeglogene 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
LyfgeniaLOVOTIBEGLOGENE AUTOTEMCELGenetix Biotherapeutics Inc.0d1b475e-5781-2bd1-e063-6294a90a73112026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2672697

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0d1b475e-5781-2bd1-e063-6294a90a731120 ML lovotibeglogene autotemcel 20000000 CELLS/ML Injection [Lyfgenia]SBD7These highlights do not include all the information needed to use LYFGENIA safely and effectively. See full prescribing information for LYFGENIA. LYFGENIA® (lovotibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 202320260407
0d1b475e-5781-2bd1-e063-6294a90a7311lyfgenia 20,000,000 CELLS/ML in 20 ML InjectionPSN7These highlights do not include all the information needed to use LYFGENIA safely and effectively. See full prescribing information for LYFGENIA. LYFGENIA® (lovotibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 202320260407
0d1b475e-5781-2bd1-e063-6294a90a7311Lyfgenia 20,000,000 CELLS/ML per 20 ML InjectionSY7These highlights do not include all the information needed to use LYFGENIA safely and effectively. See full prescribing information for LYFGENIA. LYFGENIA® (lovotibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 202320260407