{ "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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], "spl_set_id": [ "83c7ac15-ece9-47de-b83c-d575544fa449" ], "package_ndc": [ "0187-1231-50" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "2N4O9L084N" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugbatchnumb": "11669169", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MILLIGRAM, Q4WEEKS", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CITALOPRAM", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "CITALOPRAM HYDROBROMIDE" }, "openfda": { "application_number": [ "ANDA077629", "ANDA077043", "NDA215428", "ANDA077534", "ANDA077042", "ANDA078216", "ANDA077031", "ANDA077289", "ANDA077045", "NDA020822", "ANDA219985" ], "brand_name": [ "CITALOPRAM", "CITALOPRAM HYDROBROMIDE", "CELEXA" ], "generic_name": [ "CITALOPRAM", "CITALOPRAM HYDROBROMIDE" ], "manufacturer_name": [ "Chartwell Governmental & Specialty RX, LLC.", "Hikma Pharmaceuticals USA Inc.", "Almatica Pharma LLC", "Cipla USA Inc.", "Mylan Pharmaceuticals Inc.", "Hahnemann Laboratories, INC.", "Torrent Pharmaceuticals Limited", "Exelan Pharmaceuticals Inc.", "Aurobindo Pharma Limited", "QUALLENT PHARMACEUTICALS HEALTH LLC", "Amneal Pharmaceuticals LLC", "Chartwell RX, LLC", "Epic Pharma, LLC", "Allergan, Inc." ], "product_ndc": [ "68999-540", "0054-0062", "52427-691", "69097-822", "69097-823", "69097-824", "0378-6231", "0378-6232", "0378-6233", "37662-0336", "37662-0339", "37662-0343", "37662-0337", "37662-0338", "37662-0340", "37662-0341", "37662-0342", "13668-009", "13668-010", "13668-011", "76282-208", "76282-628", "76282-629", "65862-005", "65862-006", "65862-007", "82009-106", "82009-107", "82009-108", "65162-052", "65162-053", "65162-054", "62135-540", "42806-019", "42806-020", "42806-021", "0456-4010", 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"65862-007-01", "65862-007-05", "65862-007-10", "65862-007-32", "82009-106-05", "82009-107-05", "82009-108-05", "65162-052-03", "65162-052-10", "65162-052-50", "65162-052-11", "65162-053-03", "65162-053-10", "65162-053-50", "65162-053-11", "65162-054-03", "65162-054-10", "65162-054-50", "65162-054-11", "62135-540-47", "62135-540-10", "62135-540-24", "42806-019-30", "42806-019-01", "42806-019-05", "42806-019-10", "42806-020-30", "42806-020-01", "42806-020-05", "42806-020-10", "42806-021-30", "42806-021-01", "42806-021-05", "42806-021-10", "0456-4010-01", "0456-4020-01", "0456-4020-11", "0456-4020-63", "0456-4040-01", "0456-4040-11", "0456-4040-63", "59651-964-30" ], "unii": [ "I1E9D14F36", "0DHU5B8D6V" ], "nui": [ "N0000175696", "N0000000109" ], "pharm_class_epc": [ "Serotonin Reuptake Inhibitor [EPC]" ], "pharm_class_moa": [ "Serotonin Uptake Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugbatchnumb": "11665790", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MILLIGRAM, Q4WEEKS", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugbatchnumb": "11717972", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MILLIGRAM, Q4WEEKS", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugenddateformat": "102", "drugenddate": "20200115", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugbatchnumb": "11386721", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MILLIGRAM", "drugdosageform": "POWDER FOR SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "CROHN^S DISEASE", "drugstartdateformat": "102", "drugstartdate": "20171106", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201805" } } } ] }