{"effective_time":"20260709","id":"dc378404-3406-4fc0-829d-cc8273af1ca0","openfda":{"application_number":["ANDA217656"],"brand_name":["icosapent ethyl"],"generic_name":["ICOSAPENT ETHYL"],"is_original_packager":[true],"manufacturer_name":["Softgel Healthcare Private Limited"],"package_ndc":["35916-1738-1","35916-1592-1"],"product_ndc":["35916-1592","35916-1738"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["1304979","1811180"],"spl_id":["dc378404-3406-4fc0-829d-cc8273af1ca0"],"spl_set_id":["6f5838cd-4d17-401d-8e2a-652d0e73c1e9"],"substance_name":["ICOSAPENT ETHYL"],"unii":["6GC8A4PAYH"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 35916-1738-1 Icosapent Ethyl Capsules 0.5 gram 240 capsules Rx only NDC 35916-1592-1 Icosapent Ethyl Capsules 1 gram 240 capsules Rx only 0.5 mg 1 gram"],"set_id":"6f5838cd-4d17-401d-8e2a-652d0e73c1e9","spl_product_data_elements":["icosapent ethyl icosapent ethyl ICOSAPENT ETHYL ICOSAPENT .ALPHA.-TOCOPHEROL GELATIN GLYCERIN WATER TITANIUM DIOXIDE SHELLAC transparent 1738 icosapent ethyl icosapent ethyl ICOSAPENT ETHYL ICOSAPENT .ALPHA.-TOCOPHEROL GELATIN GLYCERIN WATER TITANIUM DIOXIDE SHELLAC transparent oblong 1592"],"spl_unclassified_section":["SPL UNCLASSIFIED"],"version":"2"}