Home NDC 71394-415 LUXTURNA
Product NDC 71394-415
11-digit product format 713940415
Labeler code 71394
Product ID 71394-415_173eb100-b8ab-4255-bad7-466d01195c6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name voretigene neparvovec-rzyl
Dosage form KIT
Labeler Spark Therapeutics, Inc.
Application BLA125610
Marketing category BLA
Marketing start 2017-12-19
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71394-415-01 1332a3947898…d4bfe170f9cd…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 71394-415-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 71394-415-01 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LUXTURNA
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1995884 Internal RxNorm lookup 1995886 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71394-065-01 LUXTURNA 1 in 1 VIAL, PLASTIC INJECTION, SUSPENSION 1 0.05 mg 13 71394-415-01 LUXTURNA 1 in 1 CARTON KIT 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71394-415 LUXTURNA (VORETIGENE NEPARVOVEC-RZYL) KIT [SPARK THERAPEUTICS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20240418_08313a24-e7ce-457a-bb3f-161bc45517ee.zip
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125610 Luxturna Voretigene Neparvovec 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1995886 Luxturna 5,000,000,000,000 VECTOR-GENOMES/ML in 0.5 ML Injection PSN 08313a24-e7ce-457a-bb3f-161bc45517ee 13 1995884 voretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML in 0.5 ML Injection PSN 08313a24-e7ce-457a-bb3f-161bc45517ee 13 1995886 0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection [Luxturna] SBD 08313a24-e7ce-457a-bb3f-161bc45517ee 13 1995884 0.5 ML voretigene neparvovec-rzyl 5000000000000 VECTOR-GENOMES/ML Injection SCD 08313a24-e7ce-457a-bb3f-161bc45517ee 13 1995886 Luxturna 5,000,000,000,000 VECTOR-GENOMES/ML per 0.5 ML Injection SY 08313a24-e7ce-457a-bb3f-161bc45517ee 13 1995884 voretigene neparvovec-rzyl 5,000,000,000,000 VECTOR-GENOMES/ML per 0.5 ML Injection SY 08313a24-e7ce-457a-bb3f-161bc45517ee 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71394-065-01 71394006501 1 in 1 VIAL, PLASTIC Historical 71394-415-01 71394041501 1 KIT in 1 CARTON (71394-415-01) * 1 INJECTION, SUSPENSION in 1 VIAL, PLASTIC (71394-065-01) * 1 INJECTION, SOLUTION in 1 VIAL, PLASTIC (71394-716-01) 1 kit 2017-12-19 0000-00-00 No No Current