Home NDC 87668-0100 WASKYRA
Product NDC 87668-0100
11-digit product format 876680100
Labeler code 87668
Product ID 87668-0100_63947490-d64f-4313-8dfc-9f2ffc40c991
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etuvetidigene autotemcel
Dosage form INJECTION
Route INTRAVENOUS
Labeler Orphan Therapies LLC
Application BLA125846
Marketing category BLA
Marketing start 2026-07-23
Substance ETUVETIDIGENE AUTOTEMCEL
Active strength 1000000 U/mL
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 2 matching rows.
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.
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 2026-06-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 87668-0100-1 87668010001 20 mL in 1 BAG (87668-0100-1) 20 ml 2026-07-23 0 Current