"0078-0958-19" National Drug Code (NDC)

NDC Code	0078-0958-19
Package Description	1 INJECTION, SUSPENSION in 1 BAG (0078-0958-19)
Product NDC	0078-0958
Product Type Name	CELLULAR THERAPY
Proprietary Name	Kymriah
Non-Proprietary Name	Tisagenlecleucel
Dosage Form	INJECTION, SUSPENSION
Usage	INTRAVENOUS
Start Marketing Date	20180501
Marketing Category Name	BLA
Application Number	BLA125646
Manufacturer	Novartis Pharmaceuticals Corporation
Substance Name	TISAGENLECLEUCEL
Strength	60000000
Strength Unit	1/1
Pharmacy 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]