FDA.reportPublic FDA data

KYMRIAH

Product NDC
0078-0958
11-digit product format
000780958
Labeler code
0078
Product ID
0078-0958_381f1ba3-f115-424f-9890-75eb06ab6666
Type
CELLULAR THERAPY
Nonproprietary name
tisagenlecleucel
Dosage form
INJECTION, SUSPENSION
Route
INTRAVENOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
BLA125646
Marketing category
BLA
Marketing start
2018-05-01
Substance
TISAGENLECLEUCEL
Active strength
60000000 1/1
Pharmacologic classes
CD19 Receptor Interactions [MoA], CD19-directed Chimeric Antigen Receptor [EPC], CD19-specific Chimeric Antigen Receptor [CS], Genetically-modified Autologous T Cells [EPC], Increased T Lymphocyte Activation [PE], T Lymphocytes, Cultured, Autologous, Genetically-modified [EXT]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KYMRIAHTISAGENLECLEUCELNovartis Pharmaceuticals Corporationaad3ba54-dfd3-4cb3-9e2b-c5ef895591892025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125646
ndc (product): 0078-0958

Additional Listing Data#

Finished product
Yes
Brand name base
KYMRIAH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TISAGENLECLEUCEL60000000 1/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q6C9WHR03OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1986442Internal RxNorm lookup
1986447Internal RxNorm lookup
2044973Internal RxNorm lookup
2044975Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aad3ba54-dfd3-4cb3-9e2b-c5ef89559189Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0078-0958-192023-08-01C16284748780-10191ceaa-6151-198a-e063-dbdaa90aec3eThese 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
0078-0958-192023-07-28C16284748780-10191ceaa-6151-198a-e063-dbdaa90aec3eThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0958-19KYMRIAH1 in 1 BAGINJECTION, SUSPENSION118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0958-19EA - Each0078-0958608adf2e-e07c-4a2a-bbfe-a55b4629d4bd12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0958KYMRIAH (TISAGENLECLEUCEL) INJECTION, SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]15Current NDC, Legacy NDC, 1 package rows20250321_aad3ba54-dfd3-4cb3-9e2b-c5ef89559189.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125646Kymriahtisagenlecleucel351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1986447KYMRIAH 250,000,000 CELLS InjectionPSNaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
2044975KYMRIAH 600,000,000 CELLS InjectionPSNaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
1986442tisagenlecleucel 250000000 CELLS InjectionPSNaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
2044973tisagenlecleucel 600,000,000 CELLS InjectionPSNaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
1986447tisagenlecleucel 250000000 CELLS Injection [Kymriah]SBDaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
2044975tisagenlecleucel 600000000 CELLS Injection [Kymriah]SBDaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
1986442tisagenlecleucel 250000000 CELLS InjectionSCDaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
2044973tisagenlecleucel 600000000 CELLS InjectionSCDaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
1986447Kymriah 250000000 CELLS InjectionSYaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
2044975Kymriah 600,000,000 CELLS InjectionSYaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
1986442tisagenlecleucel-T 250,000,000 CELLS InjectionSYaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
1986447tisagenlecleucel-T 250,000,000 CELLS Injection [Kymriah]SYaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
2044973tisagenlecleucel-T 600,000,000 CELLS InjectionSYaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918
2044975tisagenlecleucel-T 600,000,000 CELLS Injection [Kymriah]SYaad3ba54-dfd3-4cb3-9e2b-c5ef8955918918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0958-19000780958191 INJECTION, SUSPENSION in 1 BAG (0078-0958-19) 2018-05-010000-00-00NoNoCurrent