{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 33064 } }, "results": [ { "safetyreportversion": "6", "safetyreportid": "12168501", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20250408", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20160310", "receiptdateformat": "102", "receiptdate": "20250103", "fulfillexpeditecriteria": "1", "companynumb": "US-JNJFOC-20160307607", "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "6", "senderorganization": "JOHNSON AND JOHNSON" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "68", "patientonsetageunit": "801", "patientagegroup": "6", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Septic shock", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Acute kidney injury", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Hypovolaemic shock", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Haemoptysis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Occult blood positive", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Post procedural haematoma", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TREMFYA", "drugbatchnumb": "Unknown", "drugauthorizationnumb": "761061", "drugdosageform": "Solution for infusion", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "GUSELKUMAB" }, "openfda": { "application_number": [ "BLA761061" ], "brand_name": [ "TREMFYA" ], "generic_name": [ "GUSELKUMAB" ], "manufacturer_name": [ "Janssen Biotech, Inc." ], "product_ndc": [ "57894-640", "57894-650", "57894-651" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "GUSELKUMAB" ], "rxcui": [ "1928686", "1928689", "2118739", "2118741", "2693088", "2693092", "2693094", "2693095", "2693096", "2693097", "2711637", "2711638" ], "spl_id": [ "ebe07a22-1b8b-4403-99dc-e7f34308d5d0" ], "spl_set_id": [ "1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56" ], "package_ndc": [ "57894-650-01", "57894-650-02", "57894-640-01", "57894-640-04", "57894-640-11", "57894-640-99", "57894-640-03", "57894-640-06", "57894-651-01", "57894-651-02", "57894-651-04", "57894-651-11", "57894-651-22", "57894-651-99", "57894-651-92" ], "nui": [ "N0000192799", "N0000192798" ], "pharm_class_epc": [ "Interleukin-23 Antagonist [EPC]" ], "pharm_class_moa": [ "Interleukin-23 Antagonists [MoA]" ], "unii": [ "089658A12D" ] } }, { "drugcharacterization": "1", "medicinalproduct": "XARELTO", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "022406", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "0.5", "drugintervaldosagedefinition": "804", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Pulmonary embolism", "drugstartdateformat": "102", "drugstartdate": "20140307", "drugenddateformat": "102", "drugenddate": "20140316", "drugtreatmentduration": "10", "drugtreatmentdurationunit": "804", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "openfda": { "application_number": [ "NDA215859", "NDA022406" ], "brand_name": [ "XARELTO" ], "generic_name": [ "RIVAROXABAN" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-575", "50458-577", "50458-580", "50458-578", "50458-579", "50458-584" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RIVAROXABAN" ], "rxcui": [ "1114198", "1114202", "1232082", "1232084", "1232086", "1232088", "1549682", "1549683", "2059015", "2059017", "2588062", "2588066" ], "spl_id": [ "452610f0-5abb-448d-a1fc-9dd9be02bb66" ], "spl_set_id": [ "10db92f9-2300-4a80-836b-673e1ae91610" ], "package_ndc": [ "50458-577-60", "50458-577-18", "50458-577-14", "50458-577-01", "50458-577-10", "50458-580-01", "50458-580-10", "50458-580-30", "50458-580-07", "50458-580-90", "50458-578-01", "50458-578-10", "50458-578-30", "50458-578-90", "50458-578-14", "50458-578-07", "50458-579-01", "50458-579-10", "50458-579-30", "50458-579-90", "50458-579-99", "50458-579-07", "50458-579-89", "50458-584-51", "50458-584-52", "50458-575-01" ], "nui": [ "N0000175635", "N0000175637" ], "pharm_class_moa": [ "Factor Xa Inhibitors [MoA]" ], "pharm_class_epc": [ "Factor Xa Inhibitor [EPC]" ], "unii": [ "9NDF7JZ4M3" ] } }, { "drugcharacterization": "1", "medicinalproduct": "XARELTO", "drugbatchnumb": "Unknown", "drugauthorizationnumb": "022406", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "0.5", "drugintervaldosagedefinition": "804", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Atrial fibrillation", "drugstartdateformat": "102", "drugstartdate": "20140307", "drugenddateformat": "102", "drugenddate": "20140316", "drugtreatmentduration": "10", "drugtreatmentdurationunit": "804", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "openfda": { "application_number": [ "NDA215859", "NDA022406" ], "brand_name": [ "XARELTO" ], "generic_name": [ "RIVAROXABAN" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-575", "50458-577", "50458-580", "50458-578", "50458-579", "50458-584" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RIVAROXABAN" ], "rxcui": [ "1114198", "1114202", "1232082", "1232084", "1232086", "1232088", "1549682", "1549683", "2059015", "2059017", "2588062", "2588066" ], "spl_id": [ "452610f0-5abb-448d-a1fc-9dd9be02bb66" ], "spl_set_id": [ "10db92f9-2300-4a80-836b-673e1ae91610" ], "package_ndc": [ "50458-577-60", "50458-577-18", "50458-577-14", "50458-577-01", "50458-577-10", "50458-580-01", "50458-580-10", "50458-580-30", "50458-580-07", "50458-580-90", "50458-578-01", "50458-578-10", "50458-578-30", "50458-578-90", "50458-578-14", "50458-578-07", "50458-579-01", "50458-579-10", "50458-579-30", "50458-579-90", "50458-579-99", "50458-579-07", "50458-579-89", "50458-584-51", "50458-584-52", "50458-575-01" ], "nui": [ "N0000175635", "N0000175637" ], "pharm_class_moa": [ "Factor Xa Inhibitors [MoA]" ], "pharm_class_epc": [ "Factor Xa Inhibitor [EPC]" ], "unii": [ "9NDF7JZ4M3" ] } }, { "drugcharacterization": "1", "medicinalproduct": "XARELTO", "drugauthorizationnumb": "022406", "drugindication": "Cerebrovascular accident prophylaxis", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "openfda": { "application_number": [ "NDA215859", "NDA022406" ], "brand_name": [ "XARELTO" ], "generic_name": [ "RIVAROXABAN" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-575", "50458-577", "50458-580", "50458-578", "50458-579", "50458-584" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RIVAROXABAN" ], "rxcui": [ "1114198", "1114202", "1232082", "1232084", "1232086", "1232088", "1549682", "1549683", "2059015", "2059017", "2588062", "2588066" ], "spl_id": [ "452610f0-5abb-448d-a1fc-9dd9be02bb66" ], "spl_set_id": [ "10db92f9-2300-4a80-836b-673e1ae91610" ], "package_ndc": [ "50458-577-60", "50458-577-18", "50458-577-14", "50458-577-01", "50458-577-10", "50458-580-01", "50458-580-10", "50458-580-30", "50458-580-07", "50458-580-90", "50458-578-01", "50458-578-10", "50458-578-30", "50458-578-90", "50458-578-14", "50458-578-07", "50458-579-01", "50458-579-10", "50458-579-30", "50458-579-90", "50458-579-99", "50458-579-07", "50458-579-89", "50458-584-51", "50458-584-52", "50458-575-01" ], "nui": [ "N0000175635", "N0000175637" ], "pharm_class_moa": [ "Factor Xa Inhibitors [MoA]" ], "pharm_class_epc": [ "Factor Xa Inhibitor [EPC]" ], "unii": [ "9NDF7JZ4M3" ] } }, { "drugcharacterization": "1", "medicinalproduct": "XARELTO", "drugauthorizationnumb": "022406", "drugindication": "Thrombosis prophylaxis", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "openfda": { "application_number": [ "NDA215859", "NDA022406" ], "brand_name": [ "XARELTO" ], "generic_name": [ "RIVAROXABAN" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-575", "50458-577", "50458-580", "50458-578", "50458-579", "50458-584" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RIVAROXABAN" ], "rxcui": [ "1114198", "1114202", "1232082", "1232084", "1232086", "1232088", "1549682", "1549683", "2059015", "2059017", "2588062", "2588066" ], "spl_id": [ "452610f0-5abb-448d-a1fc-9dd9be02bb66" ], "spl_set_id": [ "10db92f9-2300-4a80-836b-673e1ae91610" ], "package_ndc": [ "50458-577-60", "50458-577-18", "50458-577-14", "50458-577-01", "50458-577-10", "50458-580-01", "50458-580-10", "50458-580-30", "50458-580-07", "50458-580-90", "50458-578-01", "50458-578-10", "50458-578-30", "50458-578-90", "50458-578-14", "50458-578-07", "50458-579-01", "50458-579-10", "50458-579-30", "50458-579-90", "50458-579-99", "50458-579-07", "50458-579-89", "50458-584-51", "50458-584-52", "50458-575-01" ], "nui": [ "N0000175635", "N0000175637" ], "pharm_class_moa": [ "Factor Xa Inhibitors [MoA]" ], "pharm_class_epc": [ "Factor Xa Inhibitor [EPC]" ], "unii": [ "9NDF7JZ4M3" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LOVENOX", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "003", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Deep vein thrombosis", "drugstartdateformat": "102", "drugstartdate": "20140227", "drugenddateformat": "610", "drugenddate": "201405", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ENOXAPARIN SODIUM" }, "openfda": { "application_number": [ "NDA020164" ], "brand_name": [ "LOVENOX" ], "generic_name": [ "ENOXAPARIN SODIUM" ], "manufacturer_name": [ "Sanofi-Aventis U.S. LLC" ], "product_ndc": [ "0075-8013", "0075-8014", "0075-8016", "0075-8018", "0075-8020", "0075-8030", "0075-8022", "0075-8025", "0075-0620", "0075-0624", "0075-0621", "0075-0622", "0075-0623", "0075-0626", "0075-2912", "0075-2915" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "ENOXAPARIN SODIUM" ], "rxcui": [ "854228", "854232", "854235", "854236", "854238", "854239", "854241", "854242", "854245", "854247", "854248", "854249", "854252", "854253", "854255", "854256" ], "spl_id": [ "006561fa-e16d-4129-9dde-89c109b51d8f", "51658faf-4b60-4c8a-a1e6-6bd612300651" ], "spl_set_id": [ "de6fb917-a94a-41ea-9d7d-937d4080ffcd", "5017a927-2a24-4f27-89f9-27c805bf7d59" ], "package_ndc": [ "0075-8013-01", "0075-8013-10", "0075-8014-01", "0075-8014-10", "0075-8016-01", "0075-8016-10", "0075-8018-01", "0075-8018-10", "0075-8020-01", "0075-8020-10", "0075-8030-01", "0075-8022-01", "0075-8022-10", "0075-8025-01", "0075-8025-10", "0075-0624-01", "0075-0624-30", "0075-0620-01", "0075-0620-40", "0075-0621-01", "0075-0621-60", "0075-0622-01", "0075-0622-80", "0075-0623-03", "0075-0623-00", "0075-0626-03", "0075-2912-00", "0075-2912-01", "0075-2915-00", "0075-2915-01" ], "unii": [ "8NZ41MIK1O" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LOVENOX", "drugindication": "Pulmonary embolism", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ENOXAPARIN SODIUM" }, "openfda": { "application_number": [ "NDA020164" ], "brand_name": [ "LOVENOX" ], "generic_name": [ "ENOXAPARIN SODIUM" ], "manufacturer_name": [ "Sanofi-Aventis U.S. LLC" ], "product_ndc": [ "0075-8013", "0075-8014", "0075-8016", "0075-8018", "0075-8020", "0075-8030", "0075-8022", "0075-8025", "0075-0620", "0075-0624", "0075-0621", "0075-0622", "0075-0623", "0075-0626", "0075-2912", "0075-2915" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "ENOXAPARIN SODIUM" ], "rxcui": [ "854228", "854232", "854235", "854236", "854238", "854239", "854241", "854242", "854245", "854247", "854248", "854249", "854252", "854253", "854255", "854256" ], "spl_id": [ "006561fa-e16d-4129-9dde-89c109b51d8f", "51658faf-4b60-4c8a-a1e6-6bd612300651" ], "spl_set_id": [ "de6fb917-a94a-41ea-9d7d-937d4080ffcd", "5017a927-2a24-4f27-89f9-27c805bf7d59" ], "package_ndc": [ "0075-8013-01", "0075-8013-10", "0075-8014-01", "0075-8014-10", "0075-8016-01", "0075-8016-10", "0075-8018-01", "0075-8018-10", "0075-8020-01", "0075-8020-10", "0075-8030-01", "0075-8022-01", "0075-8022-10", "0075-8025-01", "0075-8025-10", "0075-0624-01", "0075-0624-30", "0075-0620-01", "0075-0620-40", "0075-0621-01", "0075-0621-60", "0075-0622-01", "0075-0622-80", "0075-0623-03", "0075-0623-00", "0075-0626-03", "0075-2912-00", "0075-2912-01", "0075-2915-00", "0075-2915-01" ], "unii": [ "8NZ41MIK1O" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BENAZEPRIL", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Hypertension", "drugstartdateformat": "602", "drugstartdate": "1996", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "BENAZEPRIL HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "ATORVASTATIN", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Blood cholesterol increased", "drugstartdateformat": "602", "drugstartdate": "1996", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "ATORVASTATIN" } }, { "drugcharacterization": "2", "medicinalproduct": "PROTONIX", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Gastrooesophageal reflux disease", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "PANTOPRAZOLE SODIUM" }, "openfda": { "application_number": [ "NDA020988", "NDA020987", "NDA022020" ], "brand_name": [ "PROTONIX I.V.", "PROTONIX DELAYED-RELEASE" ], "generic_name": [ "PANTOPRAZOLE SODIUM" ], "manufacturer_name": [ "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc." ], "product_ndc": [ "0008-0923", "0008-4001", "0008-0841", "0008-0843", "0008-0844" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "ORAL" ], "substance_name": [ "PANTOPRAZOLE SODIUM" ], "rxcui": [ "283669", "885257" ], "spl_id": [ "a7e7d657-a748-4234-8dd6-c0e4d0f81a86", "d36cd2fb-517f-44e5-8438-53e563775f86", "b1adaee5-9353-48ce-bde4-f169a3787e30" ], "spl_set_id": [ "51e4144a-489e-436c-609a-39305f8f56ba", "f39b3e7d-39d2-4c8a-9974-4ab885241880", "08098cb2-c048-4640-f387-6beec4a38936" ], "package_ndc": [ "0008-0923-51", "0008-0923-60", "0008-0923-55", "0008-4001-01", "0008-4001-10", "0008-4001-25", "0008-0843-81", "0008-0841-81", "0008-0844-01", "0008-0844-02" ], "unii": [ "6871619Q5X" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LOTREL", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Hypertension", "drugstartdateformat": "602", "drugstartdate": "1996", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE\\BENAZEPRIL HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA020364" ], "brand_name": [ "LOTREL" ], "generic_name": [ "AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0364", "0078-0405", "0078-0406", "0078-0379" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "BENAZEPRIL HYDROCHLORIDE" ], "rxcui": [ "898342", "898344", "898346", "898348", "898353", "898355", "898356", "898358" ], "spl_id": [ "b9db75d9-9d1e-4b2d-9876-5f5520feaecc" ], "spl_set_id": [ "94ae6054-b7ae-4212-a567-4f803af8f2c7" ], "package_ndc": [ "0078-0405-05", "0078-0406-05", "0078-0364-05", "0078-0379-05" ], "unii": [ "N1SN99T69T", "864V2Q084H" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LISINOPRIL", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "602", "drugstartdate": "1996", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "LISINOPRIL" }, "openfda": { "application_number": [ "ANDA212041", "ANDA208920", "ANDA077321", "NDA208401", "ANDA076102", "ANDA076164", "ANDA075903", "ANDA076059", "ANDA075743", "ANDA203508", "NDA019777", "ANDA077622" ], "brand_name": [ "LISINOPRIL", "QBRELIS", "ZESTRIL" ], "generic_name": [ "LISINOPRIL" ], "manufacturer_name": [ "Chartwell RX, LLC", "Quallent Pharmaceuticals Health LLC", "Azurity Pharmaceuticals, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)", "Solco healthcare U.S., LLC", "Camber Pharmaceuticals, Inc.", "Actavis Pharma, Inc.", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Exelan Pharmaceuticals, Inc", "BluePoint Laboratories", "Exelan Pharmaceuticals Inc.", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited" ], "product_ndc": [ "62135-640", "62135-641", "62135-642", "62135-643", "62135-644", "62135-645", "82009-062", "82009-063", "82009-064", "82009-065", "82009-066", "52652-3001", "23155-876", "23155-877", "23155-878", "23155-879", "23155-880", "23155-881", "43547-351", "43547-352", "43547-353", "43547-354", "43547-355", "43547-356", "31722-172", "31722-176", "31722-177", "31722-178", "31722-179", "31722-180", "0591-0405", "0591-0406", "0591-0407", "0591-0408", "0591-0885", "0591-0409", "68180-512", "68180-513", "68180-517", "68180-980", "68180-981", "68180-982", "68180-979", "68180-514", "68180-515", "68180-516", "72865-208", "72865-209", "72865-210", "72865-211", "72865-212", "72865-213", "76282-728", "76282-729", "76282-730", "76282-731", "76282-732", "76282-733", "68001-332", "68001-337", "68001-333", "68001-486", "68001-334", "68001-335", "68001-336", "43547-414", "43547-415", "43547-416", "43547-417", "43547-418", "43547-419", "76282-417", "76282-418", "76282-419", "76282-420", "76282-421", "76282-422", "24979-238", "24979-239", "24979-240", "24979-241", "24979-242", "24979-243", "65862-037", "65862-038", "65862-039", "65862-040", "65862-041", "65862-042" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LISINOPRIL" ], "rxcui": [ "197884", "205326", "311353", "311354", "314076", "314077", "1806884", "1806890", "104375", "104376", "104377", "104378", "206771", "213482" ], "spl_id": [ "462a5023-e5a0-692a-e063-6294a90a7236", "d2b42923-6e5f-47a1-9b31-4d019142a102", "461e97d5-c8b3-75a7-e063-6394a90a6ec6", "cb748971-2531-4478-8dff-e01cd87dec09", "61b942b0-3ad3-49d4-8321-c3b01f0d7ce1", "cfe12692-404c-ae05-e053-2995a90aa182", "01764c1d-aebe-4a46-920c-4b5f8cca8acb", "6723a96d-02f8-40c2-95ec-89a7053a7117", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "c3c02066-1571-4291-ae9a-fd50a43486ad", "c5fac2c4-de1f-49d3-e053-2a95a90a5285", "1ed80b02-cb3b-41c5-ab33-ff0106b8792d", "3e79fbc7-ef6e-4f2f-99a3-7ae3c1e1eec7", "7875efff-59e3-4f68-84c5-e3c9c16d6a3c", "02e12641-9edf-4791-8684-5f148f3ed574", "337644b9-adae-41c1-9a9c-8d879ab355d2" ], "spl_set_id": [ "8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce", "f2e09150-22f2-4028-b214-917d686200ad", "9f6e4e57-a489-4b36-b093-b93865d3717c", "c6c55efa-36bd-4613-98ca-2eb589a31e53", "e299d477-a612-4af4-b6aa-f5addc8a736d", "8f20acd7-2635-4a9b-b732-2a84ea93dea7", "43e2c8d1-3704-4323-bcaf-f582572b81f7", "7d6c31e2-b5a4-4279-8013-a8dad37ea73b", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "4aad4d30-3e18-489c-80ad-ccf7532bb933", "34ebeea1-6812-4697-84c4-b2ae4f39e55f", "f8d16c85-50e2-4d99-afae-6fb902734e42", "1bc69836-a659-4e3b-84a7-a00b7c4dc268", "838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "0e6364a4-6d66-4151-8197-d45e2a762895", "387068e7-7fb9-44f3-ae1c-e45ebc755a3e" ], "package_ndc": [ "62135-640-31", "62135-640-90", "62135-641-31", "62135-641-90", "62135-642-31", "62135-642-90", "62135-643-31", "62135-643-90", "62135-644-31", "62135-644-90", "62135-645-31", "62135-645-90", "82009-062-05", "82009-063-10", "82009-064-10", "82009-065-10", "82009-066-10", "52652-3001-1", "23155-876-01", "23155-876-05", "23155-877-01", "23155-877-10", "23155-878-01", "23155-878-10", "23155-879-01", "23155-879-10", "23155-880-01", "23155-880-05", "23155-881-01", "23155-881-10", "43547-351-50", "43547-351-10", "43547-351-03", "43547-352-11", "43547-352-10", "43547-353-11", "43547-353-10", "43547-353-03", "43547-354-11", "43547-354-10", "43547-354-03", "43547-355-11", "43547-355-10", "43547-355-03", "43547-355-50", "43547-356-11", "43547-356-10", "31722-172-01", "31722-172-05", "31722-176-01", "31722-176-10", "31722-177-01", "31722-177-10", "31722-178-01", "31722-178-10", "31722-179-01", "31722-179-05", "31722-180-01", "31722-180-10", "0591-0405-01", "0591-0405-05", "0591-0406-01", "0591-0406-10", "0591-0407-01", "0591-0407-10", "0591-0408-01", "0591-0408-10", "0591-0885-01", "0591-0409-01", "0591-0409-05", "68180-512-02", "68180-512-30", "68180-512-09", "68180-512-01", "68180-512-03", "68180-513-30", "68180-513-03", "68180-513-01", "68180-513-09", "68180-513-02", "68180-513-05", "68180-517-03", "68180-517-01", "68180-517-30", "68180-517-09", "68180-517-04", "68180-517-02", "68180-980-03", "68180-980-30", "68180-980-01", "68180-980-09", "68180-980-05", "68180-980-02", "68180-981-01", "68180-981-03", "68180-981-30", "68180-981-09", "68180-981-02", "68180-981-05", "68180-982-01", "68180-982-02", "68180-982-30", "68180-982-03", "68180-982-09", "68180-979-01", "68180-979-03", "68180-979-30", "68180-979-09", "68180-514-01", "68180-514-02", "68180-514-03", "68180-514-09", "68180-514-30", "68180-514-05", "68180-515-01", "68180-515-02", "68180-515-03", "68180-515-09", "68180-515-30", "68180-515-05", "68180-516-01", "68180-516-02", "68180-516-03", "68180-516-09", "68180-516-30", "72865-208-01", "72865-208-05", "72865-209-45", "72865-209-90", "72865-209-01", "72865-209-10", "72865-210-45", "72865-210-90", "72865-210-01", "72865-210-10", "72865-210-50", "72865-211-45", "72865-211-90", "72865-211-01", "72865-211-18", "72865-211-10", "72865-211-50", "72865-212-01", "72865-212-05", "72865-213-45", "72865-213-90", "72865-213-01", "72865-213-18", "72865-213-10", "76282-728-30", "76282-728-45", "76282-728-90", "76282-728-01", "76282-728-18", "76282-728-05", "76282-728-10", "76282-729-30", "76282-729-45", "76282-729-90", "76282-729-01", "76282-729-18", "76282-729-05", "76282-729-10", "76282-730-30", "76282-730-45", "76282-730-90", "76282-730-01", "76282-730-18", "76282-730-05", "76282-730-10", "76282-730-50", "76282-731-30", "76282-731-45", "76282-731-90", "76282-731-01", "76282-731-18", "76282-731-05", "76282-731-10", "76282-731-50", "76282-732-30", "76282-732-45", "76282-732-90", "76282-732-01", "76282-732-18", "76282-732-05", "76282-732-10", "76282-733-30", "76282-733-45", "76282-733-90", "76282-733-01", "76282-733-18", "76282-733-05", "76282-733-10", "68001-337-00", "68001-337-08", "68001-332-00", "68001-332-03", "68001-333-00", "68001-333-08", "68001-486-00", "68001-486-08", "68001-334-00", "68001-334-08", "68001-335-00", "68001-335-08", "68001-336-00", "43547-414-10", "43547-414-50", "43547-415-03", "43547-415-04", "43547-415-09", "43547-415-10", "43547-415-50", "43547-415-11", "43547-415-25", "43547-416-04", "43547-416-09", "43547-416-10", "43547-416-50", "43547-416-11", "43547-416-15", "43547-417-04", "43547-417-09", "43547-417-10", "43547-417-50", "43547-417-11", "43547-417-15", "43547-418-10", "43547-418-50", "43547-419-04", "43547-419-09", "43547-419-10", "43547-419-18", "43547-419-50", "43547-419-11", "43547-419-15", "43547-419-25", "76282-417-30", "76282-417-45", "76282-417-90", "76282-417-01", "76282-417-18", "76282-417-05", "76282-417-10", "76282-418-30", "76282-418-45", "76282-418-90", "76282-418-01", "76282-418-18", "76282-418-05", "76282-418-10", "76282-419-30", "76282-419-45", "76282-419-90", "76282-419-01", "76282-419-18", "76282-419-05", "76282-419-10", "76282-419-50", "76282-420-30", "76282-420-45", "76282-420-90", "76282-420-01", "76282-420-18", "76282-420-05", "76282-420-10", "76282-420-50", "76282-421-30", "76282-421-45", "76282-421-90", "76282-421-01", "76282-421-18", "76282-421-05", "76282-421-10", "76282-422-30", "76282-422-45", "76282-422-90", "76282-422-01", "76282-422-18", "76282-422-05", "76282-422-10", "24979-238-07", "24979-239-07", "24979-240-07", "24979-241-07", "24979-242-07", "24979-243-07", "65862-037-30", "65862-037-01", "65862-037-00", "65862-037-05", "65862-037-99", "65862-038-30", "65862-038-01", "65862-038-00", "65862-038-05", "65862-038-99", "65862-039-30", "65862-039-01", "65862-039-00", "65862-039-05", "65862-039-99", "65862-040-30", "65862-040-01", "65862-040-00", "65862-040-05", "65862-040-99", "65862-041-30", "65862-041-01", "65862-041-00", "65862-041-05", "65862-041-99", "65862-042-30", "65862-042-01", "65862-042-00", "65862-042-05", "65862-042-99", "31722-172-31", "31722-176-31", "31722-177-31", "31722-178-31", "31722-179-31", "31722-180-31" ], "unii": [ "E7199S1YWR" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "602", "drugstartdate": "1996", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LIPITOR", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "602", "drugstartdate": "1996", "actiondrug": "6", "drugadditional": "4", "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": [ "e0f7e582-ef7c-4498-9871-55e4f48345ad" ], "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: 20140301" } } } ] }