Home NDC 73554-2111 Skysona
Product NDC 73554-2111
11-digit product format 735542111
Labeler code 73554
Product ID 73554-2111_1204fe44-ece9-4967-a7df-f005e166ac75
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 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 · 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
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
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 2026-06-01
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