NDC 0078-0958

KYMRIAH

Tisagenlecleucel

KYMRIAH is a Intravenous Injection, Suspension in the Cellular Therapy category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Tisagenlecleucel.

• Product ID: 0078-0958_1c241cd5-121e-4238-8c86-b24548c4aa84
• NDC: 0078-0958
• Product Type: Cellular Therapy
• Proprietary Name: KYMRIAH
• Generic Name: Tisagenlecleucel
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-05-01
• Marketing Category: BLA / BLA
• Application Number: BLA125646
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: TISAGENLECLEUCEL
• Active Ingredient Strength: 60000000 1/1
• Pharm Classes: CD19-directed Chimeric Antigen Receptor [EPC],Genetically-modified Autologous T Cells [EPC],CD19 Receptor Interactions [MoA],T Lymphocytes, Cultured, Autologous, Genetically-modified [EXT]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0958-19

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

• Marketing Start Date: 2018-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0958-19 [00078095819]

KYMRIAH INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA125646
• Product Type: CELLULAR THERAPY
• Billing Unit: EA
• Marketing Start Date: 2018-05-01

Drug Details

Active Ingredients

Ingredient	Strength
TISAGENLECLEUCEL	60000000 1/1

NDC Crossover Matching brand name "KYMRIAH" or generic name "Tisagenlecleucel"

NDC	Brand Name	Generic Name
0078-0846	KYMRIAH	tisagenlecleucel
0078-0958	KYMRIAH	tisagenlecleucel