FDA.reportPublic FDA data

exagamglogene autotemcel 13,000,000 CELLS/ML in 1.5 ML Injection

RxCUI
2671671
RxNorm name
exagamglogene autotemcel 13,000,000 CELLS/ML in 1.5 ML Injection
Display name
exagamglogene autotemcel 13,000,000 CELLS/ML in 1.5 ML Injection
Full name
exagamglogene autotemcel 13,000,000 CELLS/ML in 1.5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125787CasgevyExagamglogene autotemcel351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CASGEVYEXAGAMGLOGENE AUTOTEMCELVertex Pharmaceuticals Incorporated7c3e12ad-e2fe-4d3f-a630-ea7364d9e8462026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 2671671

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
7c3e12ad-e2fe-4d3f-a630-ea7364d9e846exagamglogene autotemcel 13,000,000 CELLS/ML in 1.5 ML Injection [PSN] · 1.5 ML exagamglogene autotemcel 13000000 CELLS/ML Injection [SCD] · exagamglogene autotemcel 13,000,000 CELLS/ML per 1.5 ML Injection [SY]313These highlights do not include all the information needed to use CASGEVY ™ safely and effectively. See full prescribing information for CASGEVY CASGEVY (exagamglogene autotemcel), suspension for intravenous infusion Initial U.S. Approval: 202320260330