NDC 73554-2111-01 - Skysona

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
73554-2111
Requested NDC
73554-2111-01
Package NDCs from labels
73554-2111-1, 73554-2111-01
Manufacturer
Genetix Biotherapeutics Inc. | Lonza Houston, Inc
Effective date
2026-07-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Skysona - Genetix Biotherapeutics Inc. | Lonza Houston, IncGenetix Biotherapeutics Inc. | Lonza Houston, Inc2026-07-21CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73554-2111-1Skysona1 in 1 BAGSUSPENSION112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73554-2111SKYSONA (ELIVALDOGENE AUTOTEMCEL) SUSPENSION [BLUEBIRD BIO, INC.]4Current NDC, Legacy NDC, 1 package rows20240418_f189502b-dc44-4289-99a6-cfba36918329.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73554-2111-1EA - Each73554-211133c8f61b-9823-4772-a842-b767fb0ea8e312022-10-06

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SkysonaELIVALDOGENE AUTOTEMCELGenetix Biotherapeutics Inc.f189502b-dc44-4289-99a6-cfba369183292026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125755
ndc (package): 73554-2111-1
ndc (product): 73554-2111
ndc11 (package): 73554211101
rxcui: 2612552
rxcui: 2612558
spl id: ce3d399f-9c4f-41c1-a4a3-09bafcdbceb4
spl set id: f189502b-dc44-4289-99a6-cfba36918329
unii: KUM75TD6SG

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.