FDA.reportPublic FDA data

tisagenlecleucel-T 250,000,000 CELLS Injection [Kymriah]

RxCUI
1986447
RxNorm name
tisagenlecleucel-T 250,000,000 CELLS Injection [Kymriah]
Display name
tisagenlecleucel-T 250,000,000 CELLS Injection [Kymriah]
Full name
tisagenlecleucel-T 250,000,000 CELLS Injection [Kymriah]
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125646Kymriahtisagenlecleucel351(a)Rx2026-07-01

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
KYMRIAHTISAGENLECLEUCELNovartis Pharmaceuticals Corporationaad3ba54-dfd3-4cb3-9e2b-c5ef895591892025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1986447

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
aad3ba54-dfd3-4cb3-9e2b-c5ef89559189KYMRIAH 250,000,000 CELLS Injection [PSN] · tisagenlecleucel 250000000 CELLS Injection [Kymriah] [SBD] · Kymriah 250000000 CELLS Injection [SY] · tisagenlecleucel-T 250,000,000 CELLS Injection [Kymriah] [SY]418These highlights do not include all the information needed to use KYMRIAH safely and effectively. See full prescribing information for KYMRIAH. KYMRIAH ® (tisagenlecleucel) suspension for intravenous infusion Initial U.S. Approval: 201720251216