FDA.reportPublic FDA data

0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection

RxCUI
2698771
RxNorm name
0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection
Display name
0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection
Full name
0.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125722KEBILIDIeladocagene exuparvovec-tneq351(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
KEBILIDIELADOCAGENE EXUPARVOVEC-TNEQPTC Therapeutics, Inc.9d6a6401-c6b5-4f29-af11-67707d2494822026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 2698771

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9d6a6401-c6b5-4f29-af11-67707d2494820.5 ML eladocagene exuparvovec-tneq 560000000000 VECTOR-GENOMES/ML InjectionSCD3These highlights do not include all the information needed to use KEBILIDI safely and effectively. See full prescribing information for KEBILIDI. KEBILIDI (eladocagene exuparvovec-tneq) suspension, for intraputaminal infusion Initial U.S. Approval: 202420260113
9d6a6401-c6b5-4f29-af11-67707d249482eladocagene exuparvovec-tneq 560,000,000,000 VECTOR-GENOMES per 0.5 ML InjectionSY3These highlights do not include all the information needed to use KEBILIDI safely and effectively. See full prescribing information for KEBILIDI. KEBILIDI (eladocagene exuparvovec-tneq) suspension, for intraputaminal infusion Initial U.S. Approval: 202420260113
9d6a6401-c6b5-4f29-af11-67707d249482eladocagene exuparvovec-tneq 560,000,000,000 VECTOR-GENOMES in 0.5 ML InjectionPSN3These highlights do not include all the information needed to use KEBILIDI safely and effectively. See full prescribing information for KEBILIDI. KEBILIDI (eladocagene exuparvovec-tneq) suspension, for intraputaminal infusion Initial U.S. Approval: 202420260113