Package 0078-0958-19

{"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"}