NDC product

KYMRIAH

NDC 0078-0958 · Novartis Pharmaceuticals Corporation

Key facts

Product NDC 0078-0958
Proprietary name KYMRIAH
Nonproprietary name tisagenlecleucel
Substances TISAGENLECLEUCEL
Dosage form INJECTION, SUSPENSION
Route INTRAVENOUS
Labeler Novartis Pharmaceuticals Corporation
Product type CELLULAR THERAPY
Marketing category BLA
Application number BLA125646
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 and 3 more
Marketing start May 1, 2018
Listing certified through Dec 31, 2026

At a glance

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The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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