Package 58468-0348-1

{"route": ["SUBCUTANEOUS"], "spl_id": "1c225007-61f2-4c48-a25e-f08b8d356a59", "openfda": {"nui": ["N0000194148", "N0000008852", "N0000193848", "M0406100", "N0000194154"], "unii": ["SV9W47ZLE1"], "rxcui": ["2709452", "2709458", "2709461", "2709464"], "spl_set_id": ["6dd2f8ac-6f90-4cbf-b197-97d74964135c"], "pharm_class_cs": ["RNA, Small Interfering [CS]"], "pharm_class_pe": ["Decreased RNA Integrity [PE]", "Increased RNA Degradation [PE]"], "pharm_class_epc": ["Antithrombin-directed RNA Interaction [EPC]", "Small Interfering RNA [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (58468-0348-1)  / .5 mL in 1 SYRINGE", "package_ndc": "58468-0348-1", "marketing_start_date": "20250328"}], "brand_name": "Qfitlia", "product_id": "58468-0348_1c225007-61f2-4c48-a25e-f08b8d356a59", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antithrombin-directed RNA Interaction [EPC]", "Decreased RNA Integrity [PE]", "Increased RNA Degradation [PE]", "RNA", "Small Interfering [CS]", "Small Interfering RNA [EPC]"], "product_ndc": "58468-0348", "generic_name": "fitusiran", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Qfitlia", "active_ingredients": [{"name": "FITUSIRAN", "strength": "50 mg/.5mL"}], "application_number": "NDA219019", "marketing_category": "NDA", "marketing_start_date": "20250328", "listing_expiration_date": "20261231"}