FDA.reportPublic FDA data

NDC 51167-290-01 - CASGEVY

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
51167-290
Requested NDC
51167-290-01
Package NDCs from labels
51167-290-01, 51167-290-09
Manufacturer
Vertex Pharmaceuticals Incorporated
Effective date
2026-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CASGEVY - Vertex Pharmaceuticals IncorporatedVertex Pharmaceuticals Incorporated2026-07-07CELLULAR THERAPY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-290-01CASGEVY20 mL in 1 VIALINJECTION, SUSPENSION2013
51167-290-09CASGEVY9 in 1 CARTONINJECTION, SUSPENSION913

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-290CASGEVY (EXAGAMGLOGENE AUTOTEMCEL) INJECTION, SUSPENSION [VERTEX PHARMACEUTICALS INCORPORATED]6Current NDC, 2 package rows20240823_7c3e12ad-e2fe-4d3f-a630-ea7364d9e846.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51167-290-09EA - Each51167-2907f5c10a7-97f9-48d6-9fa4-a5a2ac0409a912024-01-04

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
CASGEVYEXAGAMGLOGENE AUTOTEMCELVertex Pharmaceuticals Incorporated7c3e12ad-e2fe-4d3f-a630-ea7364d9e8462026-07-07Warnings, Adverse reactionsExact identifier
application number: BLA125787
ndc (package): 51167-290-09
ndc (package): 51167-290-01
ndc (product): 51167-290
ndc11 (package): 51167029001
rxcui: 2671671
rxcui: 2671677
spl id: 680dd873-8717-41be-a143-2fc36acf07ea
spl set id: 7c3e12ad-e2fe-4d3f-a630-ea7364d9e846
unii: S53L777GM8

Reported adverse events (FAERS/openFDA)#

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