Home NDC 87233-0100 WASKYRA
Product NDC 87233-0100
11-digit product format 872330100
Labeler code 87233
Product ID 87233-0100_566bfade-f4bd-4d4c-892b-444ff5345285
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etuvetidigene autotemcel
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fondazione Telethon ETS
Application BLA125846
Marketing category BLA
Marketing start 2026-07-23
Substance ETUVETIDIGENE AUTOTEMCEL
Active strength 1000000 U/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 WASKYRA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETUVETIDIGENE AUTOTEMCEL 1000000 U/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SMN5E7TJ9C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2747661 Internal RxNorm lookup 2747667 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125846 waskyra etuvetidigene autotemcel 351(a) Rx 2026-09-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87233-0100-1 87233010001 20 mL in 1 BAG (87233-0100-1) 20 ml 2026-07-23 No No Current