kymriah

Generic: tisagenlecleucel

Labeler: novartis pharmaceuticals corporation
NDC Directory CELLULAR THERAPY BLA Inactive Finished

Drug Facts

Product Profile

Brand Name kymriah
Generic Name tisagenlecleucel
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

tisagenlecleucel 60000000 1/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0958
Product ID 0078-0958_381f1ba3-f115-424f-9890-75eb06ab6666
Product Type CELLULAR THERAPY
Marketing Category BLA
Application Number BLA125646
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

Pharmacologic Class

Established (EPC)
cd19-directed chimeric antigen receptor [epc] genetically-modified autologous t cells [epc]
Mechanism of Action
cd19 receptor interactions [moa]
Chemical Structure
cd19-specific chimeric antigen receptor [cs]
Physiologic Effect
increased t lymphocyte activation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780958
Hyphenated Format 0078-0958

Supplemental Identifiers

RxCUI
1986442 1986447 2044973 2044975
UNII
Q6C9WHR03O
NUI
N0000193546 N0000193549 N0000193544 N0000193548 M000615883 N0000182157

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kymriah (source: ndc)
Generic Name tisagenlecleucel (source: ndc)
Application Number BLA125646 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 60000000 1/1
source: ndc
Packaging
  • 1 INJECTION, SUSPENSION in 1 BAG (0078-0958-19)
source: ndc

Packages (1)

0078-0958-19 1 INJECTION, SUSPENSION in 1 BAG (0078-0958-19)

Ingredients (1)

tisagenlecleucel (60000000 1/1)

Linked Drug Pages (1)

KYMRIAH ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "381f1ba3-f115-424f-9890-75eb06ab6666", "openfda": {"nui": ["N0000193546", "N0000193549", "N0000193544", "N0000193548", "M000615883", "N0000182157"], "unii": ["Q6C9WHR03O"], "rxcui": ["1986442", "1986447", "2044973", "2044975"], "spl_set_id": ["aad3ba54-dfd3-4cb3-9e2b-c5ef89559189"], "pharm_class_cs": ["CD19-specific Chimeric Antigen Receptor [CS]"], "pharm_class_pe": ["Increased T Lymphocyte Activation [PE]"], "pharm_class_epc": ["CD19-directed Chimeric Antigen Receptor [EPC]", "Genetically-modified Autologous T Cells [EPC]"], "pharm_class_moa": ["CD19 Receptor Interactions [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, SUSPENSION in 1 BAG (0078-0958-19)", "package_ndc": "0078-0958-19", "marketing_start_date": "20180501"}], "brand_name": "KYMRIAH", "product_id": "0078-0958_381f1ba3-f115-424f-9890-75eb06ab6666", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["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]"], "product_ndc": "0078-0958", "generic_name": "tisagenlecleucel", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "CELLULAR THERAPY", "brand_name_base": "KYMRIAH", "active_ingredients": [{"name": "TISAGENLECLEUCEL", "strength": "60000000 1/1"}], "application_number": "BLA125646", "marketing_category": "BLA", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}