FDA.reportPublic FDA data

0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection

RxCUI
1995884
RxNorm name
0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection
Display name
0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection
Full name
0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125610LuxturnaVoretigene Neparvovec351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUXTURNAVORETIGENE NEPARVOVEC-RZYLSpark Therapeutics, Inc.08313a24-e7ce-457a-bb3f-161bc45517ee2022-05-01Warnings, Adverse reactionsExact identifier
rxcui: 1995884

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 IDRxNorm mappingsTermsSPL versionLabelEffective
08313a24-e7ce-457a-bb3f-161bc45517eevoretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML in 0.5 ML Injection [PSN] · 0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection [SCD] · voretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML per 0.5 ML Injection [SY]313These highlights do not include all the information needed to use LUXTURNA safely and effectively. See full prescribing information for LUXTURNA. LUXTURNA (voretigene neparvovec-rzyl) intraocular suspension for subretinal injection Initial U.S. Approval: 201720220501