tisagenlecleucel-T 600,000,000 CELLS Injection [Kymriah]

RxCUI: 2044975
RxNorm name: tisagenlecleucel-T 600,000,000 CELLS Injection [Kymriah]
Display name: tisagenlecleucel-T 600,000,000 CELLS Injection [Kymriah]
Full name: tisagenlecleucel-T 600,000,000 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
BLA	Proprietary name	Proper name	License type	Status	Latest source
125646	Kymriah	tisagenlecleucel	351(a)	Rx	2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KYMRIAH	TISAGENLECLEUCEL	Novartis Pharmaceuticals Corporation	aad3ba54-dfd3-4cb3-9e2b-c5ef89559189	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 2044975

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set ID	RxNorm string	TTY	SPL version	Label	Effective
aad3ba54-dfd3-4cb3-9e2b-c5ef89559189	tisagenlecleucel-T 600,000,000 CELLS Injection [Kymriah]	SY	18	These 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: 2017	20251216
aad3ba54-dfd3-4cb3-9e2b-c5ef89559189	tisagenlecleucel 600000000 CELLS Injection [Kymriah]	SBD	18	These 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: 2017	20251216
aad3ba54-dfd3-4cb3-9e2b-c5ef89559189	Kymriah 600,000,000 CELLS Injection	SY	18	These 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: 2017	20251216
aad3ba54-dfd3-4cb3-9e2b-c5ef89559189	KYMRIAH 600,000,000 CELLS Injection	PSN	18	These 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: 2017	20251216