Package 66658-113-03

{"route": ["INTRAVENOUS"], "spl_id": "462812de-e664-609f-e063-6294a90a1e3d", "openfda": {"nui": ["M0168688", "N0000175675", "N0000175671"], "unii": ["QMS40680K6"], "rxcui": ["2643434", "2643436"], "spl_set_id": ["426f6e64-2c20-4a61-6d65-7320426f6e64"], "pharm_class_cs": ["Fibroblast Growth Factor 7 [CS]"], "pharm_class_pe": ["Increased Epithelial Proliferation [PE]"], "pharm_class_epc": ["Mucocutaneous Epithelial Cell Growth Factor [EPC]"], "manufacturer_name": ["Swedish Orphan Biovitrum AB (publ)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03)  / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)", "package_ndc": "66658-113-03", "marketing_start_date": "20230804"}], "brand_name": "KEPIVANCE", "product_id": "66658-113_462812de-e664-609f-e063-6294a90a1e3d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Fibroblast Growth Factor 7 [CS]", "Increased Epithelial Proliferation [PE]", "Mucocutaneous Epithelial Cell Growth Factor [EPC]"], "product_ndc": "66658-113", "generic_name": "palifermin", "labeler_name": "Swedish Orphan Biovitrum AB (publ)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KEPIVANCE", "active_ingredients": [{"name": "PALIFERMIN", "strength": "5.16 mg/1.2mL"}], "application_number": "BLA125103", "marketing_category": "BLA", "marketing_start_date": "20230804", "listing_expiration_date": "20261231"}