FDA.reportPublic FDA data

30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection

RxCUI
2594789
RxNorm name
30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection
Display name
30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection
Full name
30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection
Term type
SCD
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
125746Carvykticiltacabtagene autoleucel351(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
CARVYKTICILTACABTAGENE AUTOLEUCELJanssen Biotech, Inc.7d040b91-3fb8-41db-ba7f-60a36f06e2c22025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2594789

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
7d040b91-3fb8-41db-ba7f-60a36f06e2c2ciltacabtagene autoleucel 100,000,000 CELLS in 30 ML Injection [PSN] · 30 ML ciltacabtagene autoleucel 3330000 CELLS/ML Injection [SCD] · ciltacabtagene autoleucel 100,000,000 CELLS per 30 ML Injection [SY]317These highlights do not include all the information needed to use CARVYKTI safely and effectively. See full prescribing information for CARVYKTI. CARVYKTI ® (ciltacabtagene autoleucel) suspension for intravenous infusion Initial U.S. Approval: 202220251016