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

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

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
application number: BLA125646
ndc (product): 0078-0958

Purple Book Biologic Products#

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

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