{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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"application_number": [ "NDA021445" ], "brand_name": [ "ZETIA" ], "generic_name": [ "EZETIMIBE" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-178" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE" ], "rxcui": [ "349556", "352304" ], "spl_id": [ "8e5eed2a-7b64-4350-9b87-500f1b04225d" ], "spl_set_id": [ "174e45e0-45bb-48b7-9e60-8f6cfc1d22bb" ], "package_ndc": [ "78206-178-01" ], "nui": [ "N0000008553", "N0000175911" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "pharm_class_epc": [ "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "unii": [ "EOR26LQQ24" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZETIA", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosagetext": "10 MG, UNK", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "102", "drugstartdate": "20040220", "drugenddateformat": "102", "drugenddate": "20041120", "activesubstance": { "activesubstancename": "EZETIMIBE" }, "openfda": { "application_number": [ "NDA021445" ], "brand_name": [ "ZETIA" ], "generic_name": [ "EZETIMIBE" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-178" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EZETIMIBE" ], "rxcui": [ "349556", "352304" ], "spl_id": [ "8e5eed2a-7b64-4350-9b87-500f1b04225d" ], "spl_set_id": [ "174e45e0-45bb-48b7-9e60-8f6cfc1d22bb" ], "package_ndc": [ "78206-178-01" ], "nui": [ "N0000008553", "N0000175911" ], "pharm_class_pe": [ "Decreased Cholesterol Absorption [PE]" ], "pharm_class_epc": [ "Dietary Cholesterol Absorption Inhibitor [EPC]" ], "unii": [ "EOR26LQQ24" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20040430" } } } ] }