{ "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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"N0000175698", "N0000000206" ], "pharm_class_epc": [ "Xanthine Oxidase Inhibitor [EPC]" ], "pharm_class_moa": [ "Xanthine Oxidase Inhibitors [MoA]" ], "unii": [ "63CZ7GJN5I", "428673RC2Z" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COLOXYL WITH SENNA", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 DF, BID", "drugdosageform": "TABLET", "drugindication": "CONSTIPATION", "drugstartdateformat": "102", "drugstartdate": "20140325", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "DOCUSATE\\SENNOSIDES" } }, { "drugcharacterization": "2", "medicinalproduct": "LACTULOSE.", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "15 ML, BID", "drugindication": "CONSTIPATION", 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"1b869904-b3c5-4f81-a333-1f26b6b2c7bf", "456e6761-40f8-db90-e063-6394a90a2393", "2341cf95-5e57-47ab-9dc3-73afa86b786d", "3eaf2342-fb58-e0a5-e063-6394a90a7271", "ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9", "437b8b21-3264-1b6c-e063-6294a90a1d51", "bda4ccaa-fa33-4911-b3bd-12391c365f47", "b73c2ddc-a690-46e1-aa89-40fa890c9ab4", "bfb6944f-ad8c-4bcf-98bf-b0eb806e9172", "d95ab755-1c2e-4124-8ed7-075936257c25", "4618824a-2b40-3d54-e063-6394a90a4b96" ], "spl_set_id": [ "35207edd-a5fe-4369-a079-7a8b0d2f2e91", "5ae4b6da-44df-419a-9f2b-8c4d79f635c8", "72ac130a-de85-464d-9e9b-05cac0c54db1", "d6975cd8-80e0-43e2-809a-175ea7e40715", "391cfd01-c1fa-41f9-abd7-d0abe9a27634", "df62ad54-5aba-4d05-e053-2a95a90aa48d", "0f19e4ed-c90a-4330-a7fa-bf911aa98f09", "535dd1ea-b567-49f7-9a84-8ea91e78c466", "461ec39f-eeb4-4460-9b5c-62367d47162b", "6619b25c-26b7-4c43-8c4f-9d33a23c61ca", "bd9f1577-65e8-4521-b176-e5fc60a4a018", "a8af7389-3699-4873-b05a-509af7e8eaab", "3eaf273a-b49d-2595-e063-6394a90a1cf6", "59e75426-42ae-4904-941f-009181101a8a", "887157ba-3c91-4fbf-bb12-b49c6fa4252c", "00c42c5c-d19e-4130-aa08-a8bbd47d3e5b", "cbf0497c-9c8d-4dfa-bebd-64c589468401", "8658d2ee-7708-47d0-bb93-74c1f4e17960", "a89835c9-8ce5-4627-8d7d-70ff175b2e07", "3363bdbd-f0d1-45b3-8193-7fdb0a310cc2" ], "package_ndc": [ "62135-892-47", "62135-892-94", "0121-0965-01", "0121-0965-30", "0121-1930-01", "0121-1930-30", "83745-405-08", "83745-405-16", "83745-405-32", "62135-002-37", "62135-002-47", "62135-002-94", "62135-002-78", "62135-002-51", "62135-002-24", "62135-004-43", "62135-004-24", "51672-4243-9", "0116-4005-08", "0116-4005-16", "0116-4005-32", "0116-4005-15", "0116-4005-40", "0116-4005-10", "0116-4005-30", "0116-4005-41", "0116-4005-11", "0121-0577-16", "0121-4577-15", "0121-4577-40", "0121-4577-06", "0121-4577-50", "0121-1154-30", "0121-1154-40", "0121-1154-06", "0121-1154-00", "66220-719-01", "66220-719-30", "66220-729-01", "66220-729-30", "45963-439-63", "45963-439-65", "0527-5125-68", "0527-5125-70", "0527-5125-78", "0527-5125-82", "62135-003-37", "62135-003-47", "62135-003-94", "62135-003-78", "83745-249-08", "83745-249-16", "83745-249-32", "73352-900-01", "73352-900-15", "73352-905-01", "73352-905-15", "85592-819-01", "85592-819-30", "85592-829-01", "85592-829-30", "68999-002-51", "68999-002-24", "68999-004-43", "68999-004-24", "45963-438-64", "0121-0873-08", "0121-0873-16", "0121-0873-32", "0121-0873-15", "0121-1746-30", "0121-1746-40", "0121-1746-00", "0121-1746-06", "0527-5120-68", "0527-5120-70", "0527-5120-78", "18124-002-16", "69067-020-15", "69067-010-15" ], "nui": [ "N0000175811", "N0000010288", "N0000175833", "N0000009871" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_moa": [ "Osmotic Activity [MoA]", "Acidifying Activity [MoA]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "9U7D5QH5AE" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TEMAZEPAM.", "drugdosagetext": "10 MG DAILY, PRN", "drugindication": "INSOMNIA", "drugstartdateformat": "102", "drugstartdate": "20140318", "drugenddateformat": "102", "drugenddate": "20140513", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "TEMAZEPAM" }, "openfda": { "application_number": [ "ANDA203482", "ANDA071620", "ANDA211542", "ANDA071456", "ANDA071457", "ANDA201781", "NDA018163" ], "brand_name": [ "TEMAZEPAM", "RESTORIL" ], "generic_name": [ "TEMAZEPAM" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Actavis Pharma, Inc.", "Alembic Pharmaceuticals Limited", "Ascend Laboratories, LLC", "Alembic Pharmaceuticals Inc.", "Solco Healthcare U.S., LLC", "SpecGx LLC", "Amneal Pharmaceuticals of New York LLC" ], "product_ndc": [ "65162-556", "65162-583", "65162-584", "65162-557", "0228-2076", "0228-2077", "46708-379", "46708-380", "46708-381", "46708-382", "67877-146", "67877-148", "67877-149", "67877-147", "62332-379", "62332-380", "62332-381", "62332-382", "43547-611", "43547-612", "43547-613", "43547-614", "0406-9914", "0406-9915", "0406-9916", "0406-9917", "0406-9959", "0406-9960", "0406-9961", "0406-9962", "53746-556", "53746-557" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "TEMAZEPAM" ], "rxcui": [ "198241", "198242", "198243", "485489", "208463", "208464", "208465", "539384" ], "spl_id": [ "20d2675f-af6d-480c-9152-6f722fb1ea22", "3050ee1e-c494-48ce-be40-6424e9661d87", "387adad5-eb5e-429f-bc8a-b9ace387bc3f", "45d37c04-846d-4f50-ac42-52b2d051d115", "f6347a33-09dd-4938-92eb-4bcc48a31cfa", "5f04458d-b81c-47f8-ab06-3c47dffc5e4d", "300ed63a-6bbc-4dbd-ba1d-e4eda4737e09", "2794b069-e886-4191-9227-2b6c5e569b19", "18d70b19-ff94-443e-8169-cb7e87895146" ], "spl_set_id": [ "be68c6e0-17ad-40fe-9bc1-58abe24b53f6", "a4370eb4-b00d-4247-af8d-980e59fbbec6", "db839409-8e95-41d3-804e-dcd5d11f4934", "8f54731f-c5b7-492c-acb0-444c5fbb7029", "93b1be7f-ec41-46bb-a258-56cb459e2c92", "3ce42f0e-821e-4c9a-8f6b-60621628fd4b", "bc56f7fd-1aaf-48ff-8aa7-d467e59e1015", "c9bc61b4-a579-4003-98da-b6f6e381c150", "6248295e-8176-48f8-8e9d-bba6deacaf0d" ], "package_ndc": [ "65162-583-03", "65162-583-10", "65162-583-50", "65162-583-11", "65162-556-03", "65162-556-10", "65162-556-50", "65162-556-11", "65162-584-03", "65162-584-10", "65162-584-50", "65162-584-11", "65162-557-03", "65162-557-10", "65162-557-50", "65162-557-11", "0228-2076-10", "0228-2076-50", "0228-2077-10", "0228-2077-50", "46708-379-30", "46708-379-31", "46708-380-30", "46708-380-90", "46708-380-31", "46708-380-71", "46708-381-30", "46708-382-30", "46708-382-90", "46708-382-31", "46708-382-71", "67877-148-30", "67877-148-01", "67877-148-05", "67877-146-01", "67877-146-05", "67877-149-01", "67877-149-05", "67877-149-30", "67877-147-01", "67877-147-05", "62332-379-30", "62332-379-31", "62332-380-30", "62332-380-90", "62332-380-31", "62332-380-71", "62332-381-30", "62332-382-30", "62332-382-90", "62332-382-31", "62332-382-71", "43547-611-10", "43547-612-10", "43547-612-50", "43547-613-03", "43547-614-10", "43547-614-50", "0406-9915-03", "0406-9915-01", "0406-9916-01", "0406-9914-03", "0406-9917-01", "0406-9960-01", "0406-9959-03", "0406-9961-01", "0406-9962-01", "53746-556-01", "53746-556-05", "53746-557-01", "53746-557-05" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "CHB1QD2QSS" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NEXIUM", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, QD", "drugindication": "PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER", "drugstartdateformat": "102", "drugstartdate": "20130901", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "openfda": { "application_number": [ "NDA022101", "NDA021957", "NDA021153" ], "brand_name": [ "NEXIUM" ], "generic_name": [ "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-4010", "0186-5020", "0186-4020", "0186-4040", "0186-5040", "0186-4025", "0186-4050" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE" ], "rxcui": [ "606726", "606728", "606730", "606731", "692576", "692578", "861568", "861570", "861576", "861583", "1297658", "1297660", "1297761", "1297763" ], "spl_id": [ "26f66e74-b652-4b1d-bfff-62a3cc87d590" ], "spl_set_id": [ "f4853677-1622-4037-688b-fdf533a11d96" ], "package_ndc": [ "0186-5020-31", "0186-5020-54", "0186-5020-82", "0186-4010-01", "0186-4010-02", "0186-4020-01", "0186-4040-01", "0186-4040-02", "0186-5040-31", "0186-5040-35", "0186-5040-55", "0186-5040-85", "0186-5040-54", "0186-5040-82", "0186-5040-05", "0186-4025-01", "0186-4025-02", "0186-4050-01" ], "unii": [ "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RESPRIM FORTE", "drugstructuredosagenumb": "500", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "500 MG, QD", "drugindication": "ANTIFUNGAL PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20140318", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140403" } } } ] }