{ "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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"brand_name": [ "CREON" ], "generic_name": [ "PANCRELIPASE" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0032-0045", "0032-1203", "0032-1206", "0032-1212", "0032-1224", "0032-3016", "0032-0046", "0032-0047", "0032-2636", "0032-2637" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PANCRELIPASE AMYLASE", "PANCRELIPASE LIPASE", "PANCRELIPASE PROTEASE" ], "rxcui": [ "855495", "855499", "855503", "863829", "863836", "863841", "1113042", "1113046", "1373325", "1373327" ], "spl_id": [ "a43ddd93-7d01-4bb9-95e3-b0629fe8ac87" ], "spl_set_id": [ "073201aa-556d-4a70-918e-84e9616fd88d" ], "package_ndc": [ "0032-1203-70", "0032-1203-64", "0032-1206-07", "0032-1206-01", "0032-1206-56", "0032-1212-07", "0032-1212-01", "0032-1212-46", "0032-1212-13", "0032-1224-07", "0032-1224-01", "0032-1224-46", "0032-3016-28", "0032-3016-13", "0032-3016-50", "0032-3016-12", "0032-0045-70", "0032-0045-30", "0032-0046-30", "0032-0046-70", "0032-0047-30", "0032-0047-70", "0032-2636-70", "0032-2636-01", "0032-2636-30", "0032-2637-70", "0032-2637-01", "0032-2637-30" ], "unii": [ "8MYC33932O", "3560D81V50", "YOJ58O116E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CALCIUM", "drugbatchnumb": "UNKNOWN", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugenddateformat": "102", "drugenddate": "20200109", "activesubstance": { "activesubstancename": "CALCIUM" }, "openfda": { "brand_name": [ "7030 CALCIUM PREMIUM", "AG-X", "7030 CALCIUM GOLD" ], "generic_name": [ "CALCIUM" ], "manufacturer_name": [ "Apexel Co., Ltd", "APEXEL CO., LTD." ], "product_ndc": [ "55259-1112", "55259-0007", "55259-0001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CALCIUM" ], "spl_id": [ "0fa8135f-89c9-41a2-e063-6294a90a403d", "11cc283a-fe2c-f101-e063-6294a90ad2d4", "11cc310a-d82e-be44-e063-6394a90a227c" ], "spl_set_id": [ "bdc7c833-daf7-48f9-e053-2995a90ad88e", "bdee5e24-645b-7fa0-e053-2995a90a7d25", "bdc7c088-83e3-20ce-e053-2995a90abd2f" ], "package_ndc": [ "55259-1112-1", "55259-0007-1", "55259-0001-1" ], "nui": [ "M0003153", "N0000175901" ], "pharm_class_cs": [ "Calcium [CS]" ], "pharm_class_epc": [ "Calcium [EPC]" ], "unii": [ "SY7Q814VUP" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DICLOFENAC", "drugbatchnumb": "UNKNOWN", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugenddateformat": "102", "drugenddate": "20200109", "activesubstance": { "activesubstancename": "DICLOFENAC" }, "openfda": { "application_number": [ "ANDA208198", "ANDA217646", "ANDA206116", "ANDA208077", "ANDA203383", "ANDA211253" ], "brand_name": [ "DICLOFENAC SODIUM", "XICLO", "DICLOFENAC" ], "generic_name": [ "DICLOFENAC", "DICLOFENAC SODIUM" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Encube Ethicals, Inc.", "Strand Health Group", "Amneal Pharmaceuticals NY LLC", "Scholl's Wellness Company", "Altaire Pharmaceuticals Inc.", "YYBA CORP" ], "product_ndc": [ "65162-683", "21922-033", "65162-911", "83295-5500", "69238-2053", "73469-2053", "59390-149", "73581-410" ], "product_type": [ "HUMAN PRESCRIPTION DRUG", "HUMAN OTC DRUG" ], "route": [ "TOPICAL", "TRANSDERMAL", "OPHTHALMIC" ], "substance_name": [ "DICLOFENAC SODIUM", "DICLOFENAC" ], "rxcui": [ "1487074", "857700", "2705052", "2705057", "855633", "854801" ], "spl_id": [ "1affc043-5b84-4b94-97be-90f3bd954f34", "28dafbef-5a91-4435-b48d-00137ea268b5", "6feda2fe-70b6-4dbe-a969-97857501dd1f", "463f4bb7-e16f-4966-e063-6294a90a58eb", "a723bc13-8e04-48e5-8427-5cb5e6471e4a", "3f399f7d-a801-4fce-9c3a-7e3a4d6e2507", "0561ff06-43b4-493e-93f7-b778fc829036", "533653f9-f59d-7e2d-e063-6394a90a18a9" ], "spl_set_id": [ "45321aec-368d-4ca4-a0c5-2ce56fae74b2", "e7304b3e-530a-4519-aed0-bed4512d8925", "78873f83-cea9-44d4-8ad4-8cb9257e5c7f", "2d93a01c-40a9-8fb0-e063-6394a90a2cc6", "1084e0c3-6d75-4090-84dc-02a18e0299b9", "8dcbce69-945b-4913-a279-ee10871f6580", "5372866a-dab3-45c8-8c2a-755ca36c1791", "533653e8-93d5-9080-e063-6394a90a165b" ], "package_ndc": [ "65162-683-12", "21922-033-16", "65162-911-74", "83295-5500-1", "69238-2053-1", "73469-2053-1", "73469-2053-8", "59390-149-02", "59390-149-05", "73581-410-01", "73581-410-03" ], "unii": [ "QTG126297Q", "144O8QL0L1" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MARINOL", "drugbatchnumb": "UNKNOWN", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20191210", "drugenddateformat": "102", "drugenddate": "20200109", "activesubstance": { "activesubstancename": "DRONABINOL" }, "openfda": { "application_number": [ "NDA018651" ], "brand_name": [ "MARINOL" ], "generic_name": [ "DRONABINOL" ], "manufacturer_name": [ "ThePharmaNetwork, LLC" ], "product_ndc": [ "53097-568", "53097-569", "53097-570", "53097-571", "53097-572", "53097-573" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DRONABINOL" ], "rxcui": [ "197634", "197635", "197636", "205641", "205642", "205645" ], "spl_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48" ], "spl_set_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "d0efeeec-640d-43c3-8f0a-d31324a11c68" ], "package_ndc": [ "53097-568-60", "53097-569-60", "53097-570-60", "53097-571-60", "53097-572-60", "53097-573-60" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20200106" } } } ] }