Home NDC 73554-2111 Skysona
Product NDC 73554-2111
11-digit product format 735542111
Labeler code 73554
Product ID 73554-2111_ce3d399f-9c4f-41c1-a4a3-09bafcdbceb4
Type CELLULAR THERAPY
Nonproprietary name elivaldogene autotemcel
Dosage form SUSPENSION
Route INTRAVENOUS
Labeler Genetix Biotherapeutics Inc.
Application BLA125755
Marketing category BLA
Marketing start 2022-09-16
Substance ELIVALDOGENE AUTOTEMCEL
Active strength 30000000 1/1
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 Skysona
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELIVALDOGENE AUTOTEMCEL 30000000 1/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KUM75TD6SG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2612552 Internal RxNorm lookup 2612558 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 73554-2111-1 Skysona 1 in 1 BAG SUSPENSION 1 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73554-2111 SKYSONA (ELIVALDOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240418_f189502b-dc44-4289-99a6-cfba36918329.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Skysona ELIVALDOGENE AUTOTEMCEL Genetix Biotherapeutics Inc. f189502b-dc44-4289-99a6-cfba36918329 2026-07-21 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125755 ndc (product): 73554-2111
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125755 Skysona elivaldogene autotemcel 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2612552 elivaldogene autotemcel 30,000,000 CELLS/mL in 20 ML Injection PSN f189502b-dc44-4289-99a6-cfba36918329 12 2612558 skysona 30,000,000 CELLS/mL in 20 ML Injection PSN f189502b-dc44-4289-99a6-cfba36918329 12 2612558 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection [Skysona] SBD f189502b-dc44-4289-99a6-cfba36918329 12 2612552 20 ML elivaldogene autotemcel 30000000 CELLS/ML Injection SCD f189502b-dc44-4289-99a6-cfba36918329 12 2612558 20 ML Skysona 30000000 CELLS/ML Injection SY f189502b-dc44-4289-99a6-cfba36918329 12 2612552 elivaldogene autotemcel 30,000,000 CELLS/ML per 20 ML Injection SY f189502b-dc44-4289-99a6-cfba36918329 12 2612558 Skysona 30,000,000 CELLS/ML per 20 ML Injection SY f189502b-dc44-4289-99a6-cfba36918329 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 73554-2111-1 73554211101 1 SUSPENSION in 1 BAG (73554-2111-1) 1 suspension 2022-09-16 0000-00-00 No No Current