{ "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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Antagonists [MoA]", "GABA A Receptor Positive Modulators [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]" ], "unii": [ "P85X70RZWS" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE.", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "ANDA206582", "ANDA075576", "NDA209400", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", "ANDA076048", "ANDA211732", "ANDA204012", "ANDA218829", "ANDA091672", "ANDA213201", "ANDA078490", "ANDA212977", "ANDA203270" ], "brand_name": [ "GOOD NEIGHBOR 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INC.", "OHM LABORATORIES INC.", "Strategic Sourcing Services LLC", "STRATEGIC SOURCING SERVICES LLC", "GERI-CARE PHARMACEUTICALS, CORP", "Lannett Company, Inc.", "WALGREEN CO.", "Sandoz Inc", "Cardinal Health", "Chartwell RX, LLC", "CVS Pharmacy, Inc.", "HARRIS TEETER", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. Perrigo Company", "WinCo Foods, LLC", "Aurohealth LLC", "Amazon.com Services LLC", "Meijer Distribution Inc.", "Meijer Distribution Inc", "H2-Pharma, LLC", "BJWC", "CVS Pharmacy", "H E B", "Quallent Pharmaceuticals Health LLC", "Target Corporation", "Fred's, Inc.", "Wal-Mart Stores Inc", "THE KROGER COMPANY", "HyVee Inc", "Meijer, Inc.", "Dolgencorp, LLC", "Topco Associates LLC", "Dolgencorp Inc", "Zydus Lifesciences Limited", "NORTHEAST PHARMA", "P & L Development, LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Retail Business Services, LLC", "Walgreen Company", "United Natural Foods, Inc. dba UNFI", "Little Pharma, Inc.", "American Sales Company", "Golden State Medical Supply, Inc.", "Padagis Israel Pharmaceuticals Ltd", "BluePoint Laboratories", "Cardinal Health 110, LLC. dba Leader", "Twin Med LLC", "Sun Pharmaceutical Industries, Inc.", "Zydus Pharmaceuticals USA Inc.", "Walmart Inc.", "Apotex Corp", "Strategic Sourcing Services", "Rite Aid", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Rite Aid Corporation", "Rugby Laboratories", "VALU MERCHANDISERS COMPANY", "WALMART INC. 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"49035-983-62", "0113-1803-01", "0113-1803-03", "53943-038-14", "53943-038-42", "21130-137-55", "21130-137-30", "21130-137-74", "41520-802-01", "41520-802-03", "70000-0381-2", "70000-0381-1", "58602-729-05", "58602-729-61", "58602-729-62", "58602-729-64", "58602-729-65", "58602-729-01", "58602-729-02", "58602-729-03" ], "nui": [ "N0000175525", "N0000000147", "N0000182140" ], "pharm_class_epc": [ "Proton Pump Inhibitor [EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } }, { "drugcharacterization": "1", "medicinalproduct": "XCOPRI", "drugbatchnumb": "CDZ8A", "drugauthorizationnumb": "212839", "drugstructuredosagenumb": "200", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "200 MILLIGRAM, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "EPILEPSY", "drugstartdateformat": "602", "drugstartdate": "2020", "actiondrug": "4", "activesubstance": { "activesubstancename": "CENOBAMATE" }, "openfda": { "application_number": [ "NDA212839" ], "brand_name": [ "XCOPRI", "XCOPRI MAINTENANCE PACK", "XCOPRI TITRATION PACK" ], "generic_name": [ "CENOBAMATE" ], "manufacturer_name": [ "SK Life Science, Inc." ], "product_ndc": [ "71699-025", "71699-201", "71699-050", "71699-202", "71699-100", "71699-150", "71699-203", "71699-103", "71699-200", "71699-104", "71699-204" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CENOBAMATE" ], "rxcui": [ "2265695", "2265701", "2283503", "2283505", "2283507", "2283509", "2283511", "2283513", "2283517", "2283518", "2283520", "2283522", "2283523", "2283525", "2283527", "2283535", "2283536", "2283538", "2283539", "2283540", "2540431", "2540432", "2683673", "2683674" ], "spl_id": [ "a4bdf970-9ffa-11f1-b55a-0800200c9a66" ], "spl_set_id": [ "565c2126-57ae-4e29-b443-723bbe7e2072" ], "package_ndc": [ "71699-201-28", "71699-050-30", "71699-050-99", "71699-202-28", "71699-025-30", "71699-100-30", "71699-150-30", "71699-203-28", "71699-103-56", "71699-200-30", "71699-104-56", "71699-204-14" ], "nui": [ "N0000181004", "N0000193997", "N0000182139", "N0000182140", "N0000190114", "N0000187064", "N0000187063", "N0000185506" ], "pharm_class_moa": [ "Sodium Channel Antagonists [MoA]", "GABA A Receptor Positive Modulators [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]" ], "unii": [ "P85X70RZWS" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CANNABIDIOL", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "CANNABIDIOL" }, "openfda": { "application_number": [ "NDA210365" ], "brand_name": [ "EPIDIOLEX" ], "generic_name": [ "CANNABIDIOL" ], "manufacturer_name": [ "Jazz Pharmaceuticals, Inc." ], "product_ndc": [ "70127-100" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CANNABIDIOL" ], "rxcui": [ "2058900", "2058906" ], "spl_id": [ "1eb7ac65-8df5-4a4a-9156-802cfaa92b06" ], "spl_set_id": [ "8bf27097-4870-43fb-94f0-f3d0871d1eec" ], "package_ndc": [ "70127-100-01", "70127-100-10", "70127-100-06", "70127-100-60" ], "nui": [ "M0003267", "N0000187062", "N0000185504", "N0000182140", "N0000191278", "N0000191273", "N0000182138", "N0000182139", "N0000187064" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]", "UGT2B7 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]" ], "unii": [ "19GBJ60SN5" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2020" } } } ] }