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"unii": [ "48A5M73Z4Q", "A0JWA85V8F", "YRZ789OWMI" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "LOW DENSITY LIPOPROTEIN INCREASED", "drugstartdateformat": "102", "drugstartdate": "20041119", "drugenddateformat": "610", "drugenddate": "201111", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "80", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "80 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "102", "drugstartdate": "20041119", "drugenddateformat": "610", "drugenddate": "201111", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CRESTOR", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, 1X/DAY", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugenddateformat": "610", "drugenddate": "200411", "activesubstance": { "activesubstancename": "ROSUVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA021366" ], "brand_name": [ "CRESTOR" ], "generic_name": [ "ROSUVASTATIN" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0310-7560", "0310-7570", "0310-7580", "0310-7590" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ROSUVASTATIN CALCIUM" ], "rxcui": [ "859419", "859421", "859424", "859426", "859747", "859749", "859751", "859753" ], "spl_id": [ "afc9b415-ee6f-4905-a281-13e74dcf6ce6" ], "spl_set_id": [ "325a5d0e-9a72-4015-9fcd-1655fb504cee" ], "package_ndc": [ "0310-7560-90", "0310-7570-90", "0310-7580-90", "0310-7590-30" ], "unii": [ "83MVU38M7Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugindication": "CARDIOVASCULAR EVENT PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20041119", "drugenddateformat": "610", "drugenddate": "201111", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20051230" } } }, { "safetyreportversion": "1", "safetyreportid": "10004885", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-09003BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. 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