{ "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": "2026-07-30", "results": { "skip": 0, "limit": 10, "total": 66937 } }, "results": [ { "safetyreportversion": "33", "safetyreportid": "10084081", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20240716", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140417", "receiptdateformat": "102", "receiptdate": "20240412", "fulfillexpeditecriteria": "1", "companynumb": "PHHY2013CA116184", "primarysource": { "reportercountry": "CA", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "70", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "White blood cell count increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Hepatic enzyme increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Vomiting", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Small intestine carcinoma", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Malignant neoplasm progression", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Underdose", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Weight increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Malaise", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Body temperature decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Nasal congestion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Cough", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Fatigue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Arthralgia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Limb injury", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Abdominal pain upper", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Nausea", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Headache", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Pruritus", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Blood glucose increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Injection site pain", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Injection site haemorrhage", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Needle issue", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Wrong technique in product usage process", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugauthorizationnumb": "21008", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "30 MG, QMO (EVERY 4 WEEKS)", "drugadministrationroute": "030", "drugindication": "Small intestine carcinoma", "drugstartdateformat": "102", "drugstartdate": "20130429", "actiondrug": "2", "drugadditional": "1", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugauthorizationnumb": "21008", "drugstructuredosagenumb": "60", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "60 MG, QMO (EVERY 4 WEEKS)", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20131211", "actiondrug": "2", "drugadditional": "1", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugbatchnumb": "S0091, 350475", "drugauthorizationnumb": "21008", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "30 MG, QMO (EVERY 4 WEEKS)", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20140319", "actiondrug": "2", "drugadditional": "1", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SANDOSTATIN LAR DEPOT", "drugauthorizationnumb": "21008", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20160519", "actiondrug": "2", "drugadditional": "1", "activesubstance": { "activesubstancename": "OCTREOTIDE ACETATE" }, "openfda": { "application_number": [ "NDA021008" ], "brand_name": [ "SANDOSTATIN LAR DEPOT" ], "generic_name": [ "OCTREOTIDE ACETATE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0811", "0078-0818", "0078-0825" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "898589", "898591", "898601", "898603", "898605", "898607" ], "spl_id": [ "2a2ad59f-21cd-4734-9c4b-0154e9db1642" ], "spl_set_id": [ "d0b7fe9e-7000-4b79-ba3b-291ce92c14f9" ], "package_ndc": [ "0078-0811-81", "0078-0790-61", "0078-0818-81", "0078-0797-61", "0078-0825-81", "0078-0804-61" ] } }, { "drugcharacterization": "2", "medicinalproduct": "JARDIANCE", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "25 MG, QD", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PERINDOPRIL", "drugstructuredosagenumb": "8", "drugstructuredosageunit": "003", "drugdosagetext": "8 MG", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "PERINDOPRIL" } }, { "drugcharacterization": "2", "medicinalproduct": "ROSUVASTATIN", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosagetext": "20 MG", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ROSUVASTATIN" }, "openfda": { "application_number": [ "NDA021366", "ANDA207616", "ANDA206434", "ANDA206381", "ANDA207296", "ANDA206465", "ANDA206513" ], "brand_name": [ "CRESTOR", "ROSUVASTATIN" ], "generic_name": [ "ROSUVASTATIN" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP", "Camber Pharmaceuticals, Inc.", "Accord Healthcare Inc.", "ScieGen Pharmaceuticals, Inc.", "Macleods Pharmaceuticals Limited", "Quallent Pharmaceuticals Health LLC", "AiPing Pharmaceutical, Inc." ], "product_ndc": [ "0310-7560", "0310-7570", "0310-7580", "0310-7590", "31722-882", "31722-883", "31722-884", "31722-885", "16729-284", "16729-285", "16729-286", "16729-287", "50228-116", "50228-117", "50228-118", "50228-119", "33342-261", "33342-262", "33342-263", "33342-264", "82009-188", "82009-189", "82009-190", "82009-191", "11788-130", "11788-131", "11788-132", "11788-133" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ROSUVASTATIN CALCIUM", "ROSUVASTATIN" ], "rxcui": [ "859419", "859421", "859424", "859426", "859747", "859749", "859751", "859753" ], "spl_id": [ "afc9b415-ee6f-4905-a281-13e74dcf6ce6", "546deb8e-1be9-e850-e063-6294a90a0ae2", "4390ed19-e509-95ab-e063-6294a90a2b08", "2fb0db87-33a8-e6a1-e063-6294a90a5b4a", "093ea34a-0a0b-4642-8e8e-62d6fc5c37d4", "0d12ae85-71bd-4818-a82d-fd068530bd87", "42b21540-4538-4c56-adb7-b9cfe8b2b2d5" ], "spl_set_id": [ "325a5d0e-9a72-4015-9fcd-1655fb504cee", "7778df5a-82c1-4a86-8867-a3325da025ec", "3ffe0294-3997-2755-e054-00144ff8d46c", "ee4933c5-0d97-494d-ac0f-2083e0100836", "d7b9f280-bda6-40d4-9778-e45efb87ab23", "0d12ae85-71bd-4818-a82d-fd068530bd87", "913067e8-723b-4ce2-9ebc-3e10b0f0cf7a" ], "package_ndc": [ "0310-7560-90", "0310-7570-90", "0310-7580-90", "0310-7590-30", "31722-882-90", "31722-882-31", "31722-882-05", "31722-882-10", "31722-883-90", "31722-883-31", "31722-884-90", "31722-884-31", "31722-885-30", "31722-885-31", "31722-885-05", "31722-885-10", "16729-284-10", "16729-284-15", "16729-284-17", "16729-285-10", "16729-285-15", "16729-285-17", "16729-286-10", "16729-286-15", "16729-286-17", "16729-287-10", "16729-287-15", "16729-287-17", "50228-116-30", "50228-116-90", "50228-116-05", "50228-116-10", "50228-117-30", "50228-117-90", "50228-117-05", "50228-117-10", "50228-118-30", "50228-118-90", "50228-118-05", "50228-118-10", "50228-119-30", "50228-119-90", "50228-119-05", "50228-119-10", "33342-261-07", "33342-261-10", "33342-261-44", "33342-261-12", "33342-262-07", "33342-262-10", "33342-262-44", "33342-262-12", "33342-263-07", "33342-263-10", "33342-263-44", "33342-263-12", "33342-264-07", "33342-264-10", "33342-264-44", "33342-264-12", "82009-188-05", "82009-189-05", "82009-190-05", "82009-191-05", "11788-130-90", "11788-130-05", "11788-130-10", "11788-131-90", "11788-131-05", "11788-131-10", "11788-132-90", "11788-132-05", "11788-132-10", "11788-133-90", "11788-133-05", "11788-133-10" ], "unii": [ "83MVU38M7Q", "413KH5ZJ73" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140121" } } }, { "safetyreportversion": "4", "safetyreportid": "10193585", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20180508", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140524", "receiptdateformat": "102", "receiptdate": "20180214", "fulfillexpeditecriteria": "1", "companynumb": "US-SA-2013SA125690", "duplicate": "1", "reportduplicate": { "duplicatesource": "AVENTIS", "duplicatenumb": "US-SA-2013SA125690" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "75", "patientonsetageunit": "801", "patientagegroup": "6", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Brain tumour operation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Visual impairment", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Product use issue", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LANTUS SOLOSTAR", "drugbatchnumb": "7F4605A", "drugauthorizationnumb": "021081", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "DOSE:28 UNIT(S)", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "051", "drugindication": "TYPE 2 DIABETES MELLITUS", "actiondrug": "1", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS SOLOSTAR" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2219", "0088-2220" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SOLOSTAR", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "602", "drugstartdate": "2011", "actiondrug": "1", "activesubstance": { "activesubstancename": "DEVICE" } }, { "drugcharacterization": "2", "medicinalproduct": "JARDIANCE", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "1", "medicinalproduct": "SOLOSTAR", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugindication": "TYPE 2 DIABETES MELLITUS", "actiondrug": "1", "activesubstance": { "activesubstancename": "DEVICE" } }, { "drugcharacterization": "1", "medicinalproduct": "SOLOSTAR", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugindication": "TYPE 2 DIABETES MELLITUS", "actiondrug": "1", "activesubstance": { "activesubstancename": "DEVICE" } }, { "drugcharacterization": "1", "medicinalproduct": "LANTUS SOLOSTAR", "drugbatchnumb": "3F314A", "drugauthorizationnumb": "021081", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "PATIENT TAKES 14 UNITS AT MORNING AND 6 UNITS AT EVENINIG, OVER 5 YEARS", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "051", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "602", "drugstartdate": "2011", "actiondrug": "1", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS SOLOSTAR" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2219", "0088-2220" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LANTUS SOLOSTAR", "drugbatchnumb": "3F086A", "drugauthorizationnumb": "021081", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "14 U AM AND 4 U PM", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "051", "drugindication": "TYPE 2 DIABETES MELLITUS", "actiondrug": "1", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS SOLOSTAR" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2219", "0088-2220" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LANTUS SOLOSTAR", "drugauthorizationnumb": "021081", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "PATIENT TAKES 14 UNITS AT MORNING AND 6 UNITS AT EVENINIG, OVER 5 YEARS", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "051", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "602", "drugstartdate": "2011", "actiondrug": "1", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS SOLOSTAR" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2219", "0088-2220" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } } ] } }, { "safetyreportversion": "11", "safetyreportid": "10229378", "primarysourcecountry": "FI", "occurcountry": "FI", "transmissiondateformat": "102", "transmissiondate": "20180711", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessdisabling": "1", "receivedateformat": "102", "receivedate": "20140611", "receiptdateformat": "102", "receiptdate": "20180524", "fulfillexpeditecriteria": "1", "companynumb": "FI-ROCHE-1289264", "duplicate": "1", "reportduplicate": { "duplicatesource": "ROCHE", "duplicatenumb": "FI-ROCHE-1289264" }, "primarysource": { "reportercountry": "FI", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "53", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Febrile neutropenia", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Abdominal pain upper", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Bronchitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.0", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TRASTUZUMAB.", "drugauthorizationnumb": "103792", "drugstructuredosagenumb": "8", "drugstructuredosageunit": "007", "drugdosagetext": "LOADING DOSE", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "HER-2 POSITIVE BREAST CANCER", "drugstartdateformat": "102", "drugstartdate": "20130711", "drugenddateformat": "102", "drugenddate": "20130711", "actiondrug": "4", "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "openfda": { "application_number": [ "BLA761100", "BLA103792", "BLA761091" ], "brand_name": [ "ONTRUZANT", "HERCEPTIN", "HERZUMA" ], "generic_name": [ "TRASTUZUMAB" ], "manufacturer_name": [ "Organon LLC", "Genentech, Inc.", "Cephalon, Inc." ], "product_ndc": [ "78206-147", "78206-148", "50242-132", "63459-303", "63459-305" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "TRASTUZUMAB" ], "rxcui": [ "2289227", "2289232", "2289234", "2289237", "1922509", "1922512", "2107053", "2107058", "2169359", "2169362" ], "spl_id": [ "9b665849-a59e-4da6-ae51-36b3c885b85b", "7517f775-6a10-4ddd-8dfb-6704ece413d0", "49f6182a-5e0f-45ea-8a0f-b774ef28a98f" ], "spl_set_id": [ "ce2a2492-85e3-4b0a-872a-047f44e4203d", "492dbdb2-077e-4064-bff3-372d6af0a7a2", "ae71c003-883a-4cd8-ad50-e8cc9a54e971" ], "package_ndc": [ "78206-147-99", "78206-147-01", "78206-148-01", "78206-191-99", "78206-149-89", "50242-132-01", "63459-305-47", "63459-307-41", "63459-221-20", "63459-303-43" ], "nui": [ "N0000175661", "N0000020008" ], "pharm_class_epc": [ "HER2/neu Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "HER2/Neu/cerbB2 Antagonists [MoA]" ], "unii": [ "P188ANX8CK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFORMIN", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "003", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130711", "drugenddateformat": "102", "drugenddate": "20130912", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA200690", "ANDA209674", "ANDA209313" ], "brand_name": [ "METFORMIN HYDROCHLORIDE", "METFORMIN" ], "generic_name": [ "METFORMIN", "METFORMIN ER 500 MG", "METFORMIN ER 750 MG" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Ingenus Pharmaceuticals, LLC", "Granules Pharmaceuticals Inc." ], "product_ndc": [ "0378-6001", "0378-6002", "50742-633", "50742-634", "70010-491", "70010-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "1807894", "1807917", "860975", "860981" ], "spl_id": [ "2a0bac1b-3575-4b62-a74b-07f54ba064af", "3a97a225-ff03-4d81-a2fe-7f66611cc4c1", "537f5fd2-89a1-d029-e063-6394a90a9d0e" ], "spl_set_id": [ "7e41818c-60e9-4bcf-9586-7bb8d33d5e89", "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OPAMOX", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130611", "activesubstance": { "activesubstancename": "OXAZEPAM" } }, { "drugcharacterization": "2", "medicinalproduct": "JANUVIA", "drugadministrationroute": "065", "drugstartdateformat": "610", "drugstartdate": "201612", "drugenddateformat": "102", "drugenddate": "20170104", "activesubstance": { "activesubstancename": "SITAGLIPTIN PHOSPHATE" }, "openfda": { "application_number": [ "NDA021995" ], "brand_name": [ "JANUVIA" ], "generic_name": [ "SITAGLIPTIN" ], "manufacturer_name": [ "Merck Sharp & Dohme LLC" ], "product_ndc": [ "0006-0112", "0006-0221", "0006-0277" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SITAGLIPTIN PHOSPHATE" ], "rxcui": [ "665036", "665040", "665044", "2709603", "2709608", "2709612" ], "spl_id": [ "71d449de-955b-4711-9a44-1e1f66e2e9eb" ], "spl_set_id": [ "f85a48d0-0407-4c50-b0fa-7673a160bf01" ], "package_ndc": [ "0006-0221-01", "0006-0221-28", "0006-0221-31", "0006-0221-54", "0006-0112-01", "0006-0112-28", "0006-0112-31", "0006-0112-54", "0006-0277-01", "0006-0277-28", "0006-0277-31", "0006-0277-54", "0006-0277-02", "0006-0277-33", "0006-0277-82", "0006-0277-14", "0006-0277-27", "0006-0277-30" ], "unii": [ "TS63EW8X6F" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METOCLOPRAMIDE.", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20131003", "activesubstance": { "activesubstancename": "METOCLOPRAMIDE" }, "openfda": { "application_number": [ "ANDA073135", "ANDA073118", "ANDA204756", "ANDA078807", "ANDA091392", "ANDA070184", "ANDA072801", "ANDA071402", "ANDA072744", "ANDA072215", "NDA017854" ], "brand_name": [ "METOCLOPRAMIDE" ], "generic_name": [ "METOCLOPRAMIDE", "METOCLOPRAMIDE HYDROCHLORIDE" ], "manufacturer_name": [ "Teva Parenteral Medicines, Inc.", "Hospira, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Ipca Laboratories Limited", "Avenacy, LLC", "Fresenius Kabi USA, LLC", "Teva Pharmaceuticals USA, Inc.", "ANI Pharmaceuticals, Inc.", "Genus Lifesciences Inc.", "ScieGen Pharmaceuticals, Inc.", "PAI Holdings, LLC dba PAI Pharma" ], "product_ndc": [ "0703-4502", "0409-3414", "23155-240", "83980-010", "83980-011", "83634-779", "0409-5255", "76045-101", "76045-213", "0093-2203", "0093-2204", "62559-190", "64950-344", "50228-232", "50228-233", "62559-295", "62559-296", "0121-0576", "0121-1576" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS", "ORAL" ], "substance_name": [ "METOCLOPRAMIDE HYDROCHLORIDE" ], "rxcui": [ "311670", "311666", "311668", "727619", "104884" ], "spl_id": [ "e4deb814-efe2-4ed2-84e6-fc9cde89d9e5", "d913cdad-c1da-40b5-b72f-4e6a143971e6", "b5e5868d-a0b2-4983-8c72-08199013d64b", "17ca2ec2-862d-4060-8682-a9b011d0e787", "620bde2b-b8c1-4c76-a2d1-acc0af3b5859", "ba0bb71a-9eae-4e98-8841-bb1d7e231164", "4a411ded-d608-41d3-bb26-67d5d5d3c9b5", "61b5d2d5-1e7b-44ff-a831-1a0de78edecd", "f69b0326-ca76-4a50-b5ed-1884043326e1", "b140243d-3e3b-4a75-b55a-e224774af49f", "c3ef09b0-2ebe-43d3-abb3-35aaca75e1c8", "50b47676-8433-bfb9-e063-6394a90a124c", "6d4ed2af-6756-4e7a-8325-820490408f5f", "9e77216c-c14e-4318-8569-288652321db9" ], "spl_set_id": [ "cccf04bd-7463-40b8-a41f-cb1093c358d7", "373ba08b-33ad-49fc-28a7-928e89a65314", "50a3cf38-66dc-4fa5-8a45-adf959c987ab", "c143e210-4ce7-44e5-b1e2-bf0e6bfde485", "dc4a13f8-1e9b-4c75-82c0-bcd11f0a9a66", "146803a1-199d-4789-b128-e974bdd03322", "cc739885-e10e-4bcb-a781-c726c518f3d1", "e15905e0-e0f6-4c8b-ac19-59724d6c4bf0", "5645a752-8868-4b51-8b59-48bb4276d763", "4e12e98a-06fe-4b3c-bb64-f2701e195c74", "74358569-7a24-4a59-a7fc-500d2341d6cb", "b16ad17c-eeea-407e-91e4-36506e9aa698", "797aad80-0597-42f8-99d5-39de180c3b5a", "3cc8ca5b-8b71-4c77-a181-9ce154597b9a" ], "package_ndc": [ "0703-4502-01", "0703-4502-04", "0409-3414-18", "0409-3414-01", "0409-3414-21", "0409-3414-11", "23155-240-32", "23155-240-42", "23155-240-31", "23155-240-41", "23155-240-33", "23155-240-43", "83980-010-13", "83980-010-01", "83980-010-05", "83980-010-10", "83980-011-13", "83980-011-01", "83980-011-05", "83980-011-10", "83634-779-41", "83634-779-02", "0409-5255-02", "0409-5255-25", "0409-5255-10", "0409-5255-15", "76045-101-00", "76045-101-20", "76045-213-00", "76045-213-20", "0093-2204-01", "0093-2204-05", "0093-2203-01", "0093-2203-05", "0093-2203-10", "0703-4502-91", "0703-4502-93", "62559-190-16", "64950-344-16", "50228-232-01", "50228-232-05", "50228-233-01", "50228-233-05", "50228-233-10", "62559-295-01", "62559-296-01", "0121-0576-16", "0121-1576-10" ], "unii": [ "W1792A2RVD" ] } }, { "drugcharacterization": "2", "medicinalproduct": "KEFEXIN", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20140618", "drugenddateformat": "102", "drugenddate": "20140624", "activesubstance": { "activesubstancename": "CEPHALEXIN" } }, { "drugcharacterization": "2", "medicinalproduct": "FURESIS", "drugdosagetext": "20-40MG", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130627", "activesubstance": { "activesubstancename": "FUROSEMIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "NOVORAPID", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130711", "drugenddateformat": "102", "drugenddate": "20131101", "activesubstance": { "activesubstancename": "INSULIN ASPART" } }, { "drugcharacterization": "2", "medicinalproduct": "JARDIANCE", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20161017", "drugenddateformat": "102", "drugenddate": "20161213", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TEMAZEPAM.", "drugadministrationroute": "065", "drugindication": "INSOMNIA", "drugstartdateformat": "102", "drugstartdate": "20130611", "drugenddateformat": "102", "drugenddate": "20141201", "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", "23e08cbc-80d4-4938-8d56-10e7682b5336", "f6347a33-09dd-4938-92eb-4bcc48a31cfa", "5f04458d-b81c-47f8-ab06-3c47dffc5e4d", "f0ee4fa9-cdff-4111-83a5-0885c81de4e4", "973fc0b9-31b8-4958-9cb6-bd1ae12538e9", "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": "TEMAZEPAM.", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20140601", "drugenddateformat": "102", "drugenddate": "20141201", "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", "23e08cbc-80d4-4938-8d56-10e7682b5336", "f6347a33-09dd-4938-92eb-4bcc48a31cfa", "5f04458d-b81c-47f8-ab06-3c47dffc5e4d", "f0ee4fa9-cdff-4111-83a5-0885c81de4e4", "973fc0b9-31b8-4958-9cb6-bd1ae12538e9", "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": "NOVORAPID", "drugdosagetext": "5 UNITS", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20160823", "activesubstance": { "activesubstancename": "INSULIN ASPART" } }, { "drugcharacterization": "2", "medicinalproduct": "METFOREM", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20160921", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "JARDIANCE", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20161214", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PERTUZUMAB.", "drugbatchnumb": "1107453,1149278,1122401,1107242,110", "drugauthorizationnumb": "125409", "drugstructuredosagenumb": "420", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "3", "drugintervaldosagedefinition": "803", "drugdosagetext": "FOLLOWED BY THE MAINTAINANCE DOSE?ON 11/JUL/2013, LAST DOSE OF PERTUZUMAB PRIOR TO FIRST EPISODE OF", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20130801", "actiondrug": "4", "activesubstance": { "activesubstancename": "PERTUZUMAB" }, "openfda": { "application_number": [ "BLA125409" ], "brand_name": [ "PERJETA" ], "generic_name": [ "PERTUZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-145" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "PERTUZUMAB" ], "rxcui": [ "1298948", "1298953" ], "spl_id": [ "dfebfe9c-a0c5-41d8-bf11-ed643627e264" ], "spl_set_id": [ "17f85d17-ab71-4f5b-9fe3-0b8c822f69ff" ], "package_ndc": [ "50242-145-01" ], "nui": [ "N0000175661", "N0000020008" ], "pharm_class_epc": [ "HER2/neu Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "HER2/Neu/cerbB2 Antagonists [MoA]" ], "unii": [ "K16AIQ8CTM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "KALCIPOS-D", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "HYPOCALCAEMIA", "drugstartdateformat": "102", "drugstartdate": "20130912", "drugenddateformat": "102", "drugenddate": "20140601", "activesubstance": { "activesubstancename": "CALCIUM CARBONATE\\CHOLECALCIFEROL" } }, { "drugcharacterization": "2", "medicinalproduct": "HISTEC", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20150827", "drugenddateformat": "102", "drugenddate": "20150827", "activesubstance": { "activesubstancename": "CETIRIZINE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "SOMAC", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20150827", "drugenddateformat": "102", "drugenddate": "20150827", "activesubstance": { "activesubstancename": "PANTOPRAZOLE SODIUM" } }, { "drugcharacterization": "2", "medicinalproduct": "CLINDAMYCIN.", "drugadministrationroute": "048", "drugindication": "SKIN INFECTION", "activesubstance": { "activesubstancename": "CLINDAMYCIN" }, "openfda": { "application_number": [ "ANDA090108", "NDA050782" ], "brand_name": [ "CLINDAMYCIN", "CLINDAGEL" ], "generic_name": [ "CLINDAMYCIN PHOSPHATE", "CLINDAMYCIN" ], "manufacturer_name": [ "Sagent Pharmaceuticals", "Bausch Health US, LLC" ], "product_ndc": [ "25021-115", "16781-462" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS", "TOPICAL" ], "substance_name": [ "CLINDAMYCIN PHOSPHATE" ], "rxcui": [ "1737244", "1737578", "1737581", "309332", "351330" ], "spl_id": [ "4662502b-ce7c-4278-854d-cf8632ac9b83", "cb49818a-19bc-4bcc-8696-a8b749fefbe4" ], "spl_set_id": [ "7a6967b3-5563-4bed-9eee-d400f800e799", "f7b4e985-719a-4547-b624-94612d520991" ], "package_ndc": [ "25021-115-02", "25021-115-04", "25021-115-06", "16781-462-75", "16781-462-40", "16781-462-07", "16781-462-06" ], "unii": [ "EH6D7113I8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PANADOL (FINLAND)", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20130711" }, { "drugcharacterization": "2", "medicinalproduct": "DEXAMETHASON", "drugdosagetext": "15 MG DURING 3 DAYS", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130711", "drugenddateformat": "102", "drugenddate": "20131027", "activesubstance": { "activesubstancename": "DEXAMETHASONE" } }, { "drugcharacterization": "2", "medicinalproduct": "DALACIN", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300MG X 2", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20160804", "drugenddateformat": "102", "drugenddate": "20160810", "activesubstance": { "activesubstancename": "CLINDAMYCIN" } }, { "drugcharacterization": "2", "medicinalproduct": "DIFLUCAN", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20170322", "drugenddateformat": "102", "drugenddate": "20170323", "activesubstance": { "activesubstancename": "FLUCONAZOLE" }, "openfda": { "application_number": [ "NDA020090" ], "brand_name": [ "DIFLUCAN" ], "generic_name": [ "FLUCONAZOLE" ], "manufacturer_name": [ "Roerig" ], "product_ndc": [ "0049-3450", "0049-3410", "0049-3420", "0049-3500", "0049-3430", "0049-3440" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FLUCONAZOLE" ], "rxcui": [ "197698", "197699", "197700", "197701", "201900", "201901", "207106", "207107", "207108", "207112", "310352", "310353" ], "spl_id": [ "c835d7dd-af65-4b2c-a92c-42d1986f902d" ], "spl_set_id": [ "f694c617-3383-416c-91b6-b94fda371204" ], "package_ndc": [ "0049-3410-30", "0049-3420-30", "0049-3420-41", "0049-3500-79", "0049-3430-30", "0049-3430-41", "0049-3440-19", "0049-3450-19" ], "nui": [ "N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504" ], "pharm_class_epc": [ "Azole Antifungal [EPC]" ], "pharm_class_cs": [ "Azoles [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]" ], "unii": [ "8VZV102JFY" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TRASTUZUMAB.", "drugauthorizationnumb": "103792", "drugstructuredosagenumb": "6", "drugstructuredosageunit": "007", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "3", "drugintervaldosagedefinition": "803", "drugdosagetext": "FOLLOWED BY THE MAINTAINANCE DOSE.?ON 11/JUL/2013, LAST DOSE OF TRASTUZUMAB PRIOR TO FIRST EPISODE O", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20130801", "actiondrug": "4", "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "openfda": { "application_number": [ "BLA761100", "BLA103792", "BLA761091" ], "brand_name": [ "ONTRUZANT", "HERCEPTIN", "HERZUMA" ], "generic_name": [ "TRASTUZUMAB" ], "manufacturer_name": [ "Organon LLC", "Genentech, Inc.", "Cephalon, Inc." ], "product_ndc": [ "78206-147", "78206-148", "50242-132", "63459-303", "63459-305" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "TRASTUZUMAB" ], "rxcui": [ "2289227", "2289232", "2289234", "2289237", "1922509", "1922512", "2107053", "2107058", "2169359", "2169362" ], "spl_id": [ "9b665849-a59e-4da6-ae51-36b3c885b85b", "7517f775-6a10-4ddd-8dfb-6704ece413d0", "49f6182a-5e0f-45ea-8a0f-b774ef28a98f" ], "spl_set_id": [ "ce2a2492-85e3-4b0a-872a-047f44e4203d", "492dbdb2-077e-4064-bff3-372d6af0a7a2", "ae71c003-883a-4cd8-ad50-e8cc9a54e971" ], "package_ndc": [ "78206-147-99", "78206-147-01", "78206-148-01", "78206-191-99", "78206-149-89", "50242-132-01", "63459-305-47", "63459-307-41", "63459-221-20", "63459-303-43" ], "nui": [ "N0000175661", "N0000020008" ], "pharm_class_epc": [ "HER2/neu Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "HER2/Neu/cerbB2 Antagonists [MoA]" ], "unii": [ "P188ANX8CK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "JANUVIA", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20131003", "drugenddateformat": "102", "drugenddate": "20151231", "activesubstance": { "activesubstancename": "SITAGLIPTIN PHOSPHATE" }, "openfda": { "application_number": [ "NDA021995" ], "brand_name": [ "JANUVIA" ], "generic_name": [ "SITAGLIPTIN" ], "manufacturer_name": [ "Merck Sharp & Dohme LLC" ], "product_ndc": [ "0006-0112", "0006-0221", "0006-0277" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SITAGLIPTIN PHOSPHATE" ], "rxcui": [ "665036", "665040", "665044", "2709603", "2709608", "2709612" ], "spl_id": [ "71d449de-955b-4711-9a44-1e1f66e2e9eb" ], "spl_set_id": [ "f85a48d0-0407-4c50-b0fa-7673a160bf01" ], "package_ndc": [ "0006-0221-01", "0006-0221-28", "0006-0221-31", "0006-0221-54", "0006-0112-01", "0006-0112-28", "0006-0112-31", "0006-0112-54", "0006-0277-01", "0006-0277-28", "0006-0277-31", "0006-0277-54", "0006-0277-02", "0006-0277-33", "0006-0277-82", "0006-0277-14", "0006-0277-27", "0006-0277-30" ], "unii": [ "TS63EW8X6F" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ESOMEPRAZOLE", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20131003", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE" }, "openfda": { "application_number": [ "ANDA207193", "ANDA212866", "ANDA208511", "ANDA212507" ], "brand_name": [ "KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM", "ESOMEPRAZOLE MAGNESIUM", "ESOMEPRAZOLE", "DG HEALTH ESOMEPRAZOLE MAGNESIUM", "LEADER ESOMEPRAZOLE MAGNESIUM", "GOOD NEIGHBOR PHARMACY ESOMEPRAZOLE MAGNESIUM", "EQUATE ESOMEPRAZOLE MAGNESIUM", "SIGNATURE CARE ESOMEPRAZOLE MAGNESIUM", "BASIC CARE ESOMEPRAZOLE MAGNESIUM", "GOOD SENSE ESOMEPRAZOLE MAGNESIUM", "MEMBERS MARK ESOMEPRAZOLE MAGNESIUM", "EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM", "UP AND UP ESOMEPRAZOLE MAGNESIUM", "CAREONE ESOMEPRAZOLE MAGNESIUM", "BERKLEY AND JENSEN HEARTBURN TREATMENT", "FOSTER AND THRIVE ACID REDUCER", "RIOPAN" ], "generic_name": [ "ESOMEPRAZOLE", "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Costco Wholesale Company", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "INNOVUS PHARMACEUTICALS, INC.", "Dolgencorp, LLC", "YYBA CORP", "Macleods Pharmaceuticals Limited", "Cardinal Health 110, LLC. dba Leader", "Amerisource Bergen", "CVS Pharmacy", "Wal-Mart Stores Inc", "HyVee Inc", "Dolgencorp Inc", "Safeway", "H E B", "VALU MERCHANDISERS COMPANY", "THE KROGER COMPANY", "Amazon.com Services LLC", "Rite Aid Corporation", "L. Perrigo Company", "Sam's West Inc", "CVS", "Army & Air Force Exchange Service", "Target Corporation", "Safeway, Inc.", "American Sales Company", "Walgreen Company", "HARRIS TEETER", "Ohm Laboratories Inc.", "Publix Super Markets Inc", "Meijer, Inc.", "BJWC", "Meijer Distribution Inc", "Strategic Sourcing Services LLC", "OPMX LLC", "Kroger Company", "WALMART INC." ], "product_ndc": [ "63981-898", "51316-220", "57483-900", "55910-250", "73581-013", "33342-306", "33342-307", "70000-0727", "46122-641", "69842-898", "49035-921", "42507-898", "55910-593", "21130-714", "37808-719", "21130-088", "63941-999", "30142-989", "55910-640", "72288-700", "11822-0024", "72288-898", "0113-0651", "11822-0898", "68196-898", "51316-715", "55301-898", "11673-898", "0113-2022", "21130-926", "41520-727", "0363-7223", "72036-982", "51660-027", "56062-898", "79481-0411", "68391-898", "72288-560", "0113-0898", "41250-900", "70677-1099", "69729-791", "30142-273", "79903-419" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE", "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "ESOMEPRAZOLE MAGNESIUM" ], "rxcui": [ "606726", "606730", "433733" ], "spl_id": [ "7eb4e2fc-b372-464a-b0aa-d63d52c6717e", "ff0d65ca-7ca9-4689-b5f9-1065402c91b2", "8f25bf5e-bf0d-413e-8f91-d3537939592b", "3924ab5d-59a4-41c0-9ff8-b03ac6dd317a", "43f3c680-d4a7-5094-e063-6394a90a6ef0", "d68c9247-91c7-4e0f-adc4-2cfa7446580f", "70bfe4f8-4dba-4b46-abbd-7ff48928c9d5", "855c9137-5be7-405e-82af-61c6cd8ed401", "49ebfeb6-d3ff-4eca-a18b-6c54d6dae782", "d4a545cc-a934-4205-97e0-ceb4550d86d1", "320a5a94-ab7d-4d44-9201-b73e7aab50e5", "1c810178-5b0b-4390-bf2e-ee36839b2617", "f00018f1-772f-4ac0-a1fe-41c1f59c15f0", "e03b4775-6fd8-4d45-83e8-bc405104c539", "71c83766-70ff-401d-901a-41f66ed26f55", "2bac9451-0cc9-49a4-ad53-5ca6648a64ce", "d1f98f06-8779-4753-af5f-b45fffea3d92", "d5a842f3-d21b-4ddf-87f1-e44daf5cfe05", "4df7a0fa-f656-49a8-85fb-2ad2ee20bf28", "8fc50397-c8e2-4b2b-9fd6-8ad14f6a3fd6", "2eb11ddf-dd57-441d-beb9-23690187f152", "d4793305-cd87-49cc-b1b1-7c891c986d88", "aea67549-d9d2-4431-8973-a5b6a6909a03", "566fb836-800f-4bbc-baf0-5ae366d06d55", "3ed41fde-979d-6204-e063-6394a90ad1c1", "1ee6f7c0-dff3-4372-a901-c2adef3902b1", "77452ea9-bfd7-426f-9a66-1f5f759b4295", "674a7792-7ba0-4a78-acd3-0dfcde8128d5", "8b9a5e10-02a5-4a3d-a4c2-83ca4e47c02d", "96c2b7f1-ae2c-4b41-b58a-183b654a70ff", "1b5303d0-8b4e-4420-b976-03ba683923db", "97ef0c76-1b40-4263-9ec0-eba9a9f3d454", "53a1652c-a8b0-ed15-e063-6394a90a0a6b", "dd61324d-e918-43f2-8c65-ddbdf7102fee", "aee69f51-77b9-48c9-8de3-2aa42dc88125", "ef5ff944-86d5-487c-86df-e255793a9f52", "0c2ceff8-ed3a-425c-8cd7-22600d26406a", "34b0e9f8-27ec-49a8-a373-2a43ce42861d", "bda89e2d-5798-402f-9ddb-c8f4d7fc9140", "5c410f5e-26ec-470a-93cb-9be23e33e788", "4dc7f12f-7e83-aca2-e063-6294a90ac1dc", "a0b2b851-7ffd-4143-a57b-0d4f18902268", "4adcde28-8101-4dc3-88e6-c78ba95fc746" ], "spl_set_id": [ "4a87d5d5-c98b-4dc5-81be-50183342b047", "19fa87e4-8225-4969-9857-1bf43db4427b", "b3d10f0b-52af-408c-9b3d-f8f25f7c42bd", "8f974698-ce9c-4ffb-b77e-9bad2c2ee2a1", "0912d311-e26c-479d-9f13-ef0ac403e9b8", "d68c9247-91c7-4e0f-adc4-2cfa7446580f", "c9472b82-d345-4531-bf07-bd55c94876ab", "b596055c-98b2-47b1-b174-ae7ad3ba97ee", "6f1d75c1-3c0d-41c2-a625-1ee1bf642c32", "aaafc536-f846-4019-a629-b52b3f36e682", "b0968243-171e-428a-b692-740e0c05a0fc", "2b0e555d-3ed5-4ec4-82a6-855351c503b3", "972bb479-7146-454d-ace4-f9314f0e584e", "0d08dd06-8df6-43ff-9033-8eebd215bec1", "238b27e3-6993-4213-b7eb-062309398d1b", "ab83bbdd-2c8e-46bd-b39e-69199e004be4", "7fa75bbe-5b9f-49ca-84de-f80e5a858de4", "d5a842f3-d21b-4ddf-87f1-e44daf5cfe05", "0b115351-318c-4bd9-935c-704a09bcdf52", "c55a4f7a-3b24-47e5-8ade-3b13df003301", "2466913b-7292-4dfd-8ac9-429256faacee", "e54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec", "6996642f-a63e-4be9-aefd-0634e9914c2b", "87913038-4b90-40a0-bce5-2d368bd5758c", "b68035d0-195a-41e8-9928-8b1bd57917c0", "5fa9089f-90d1-48b6-bb79-c6171eeeaa03", "717e5d5b-4bf7-415e-b259-44056bc96d8b", "f13088de-6841-453e-acb0-08bbdf9529d1", "7c497204-29ce-45e0-84d4-91b981c9b7aa", "3f9a2747-8afd-4898-bbfb-5f379293137e", "d6a55d37-c53b-4451-859b-4dbe1988eb9d", "ea9ef7b0-7397-470f-b852-397e8b0e66e4", "e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4", "60554fd6-96d5-4e73-b676-332116caa800", "8799c88f-dafb-4be6-b279-a54d916162fe", "2369c948-d46f-4ace-bc51-47477631bc43", "42dd2e93-776c-4f49-b590-afc7dab6ef2f", "4a89b4b5-5c42-44ee-98a9-e26a237aaef7", "126c269b-260d-40f4-879d-169c09251c67", "32933772-c0ef-46ad-84e5-d70218bcc866", "4c37280d-25b6-ad2f-e063-6394a90a0b9d", "da02c079-ed18-4896-896d-0489c8f43554", "ce5f2915-327d-4a91-b7fd-e399664a250f" ], "package_ndc": [ "63981-898-01", "63981-898-03", "51316-220-01", "51316-220-03", "57483-900-42", "55910-250-01", "55910-250-02", "55910-250-03", "73581-013-42", "33342-306-07", "33342-306-10", "33342-307-07", "33342-307-10", "70000-0727-2", "70000-0727-1", "46122-641-63", "46122-641-04", "69842-898-01", "69842-898-02", "69842-898-03", "49035-921-01", "49035-921-02", "49035-921-03", "49035-921-14", "49035-921-28", "49035-921-42", "42507-898-00", "42507-898-42", "55910-593-01", "55910-593-02", "55910-593-03", "21130-714-01", "21130-714-03", "37808-719-01", "37808-719-03", "21130-088-01", "21130-088-02", "21130-088-03", "63941-999-42", "63941-999-14", "30142-989-14", "30142-989-28", "55910-640-01", "72288-700-01", "72288-700-03", "11822-0024-5", "11822-0024-7", "72288-898-01", "72288-898-03", "0113-0651-01", "0113-0651-02", "0113-0651-03", "11822-0898-1", "11822-0898-2", "11822-0898-3", "68196-898-01", "68196-898-03", "51316-715-42", "51316-715-28", "51316-715-14", "55301-898-01", "55301-898-03", "11673-898-01", "11673-898-03", "0113-2022-01", "0113-2022-02", "21130-926-42", "21130-926-28", "21130-926-14", "41520-727-01", "41520-727-03", "41520-727-02", "0363-7223-03", "0363-7223-01", "72036-982-42", "51660-027-44", "51660-027-27", "51660-027-14", "56062-898-01", "56062-898-02", "56062-898-03", "79481-0411-1", "79481-0411-0", "68391-898-00", "68391-898-03", "72288-560-01", "72288-560-03", "0113-0898-01", "0113-0898-02", "0113-0898-03", "41250-900-01", "41250-900-02", "41250-900-03", "70677-1099-1", "70677-1099-2", "70677-1099-3", "69729-791-14", "30142-273-01", "30142-273-03", "79903-419-14", "79903-419-42" ], "nui": [ "N0000175525", "N0000000147", "N0000182140" ], "pharm_class_epc": [ "Proton Pump Inhibitor [EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "N3PA6559FT", "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ARTELAC EYE DROPS", "drugdosagetext": "DROPS WHEN NEEDED", "drugadministrationroute": "065", "drugstartdateformat": "610", "drugstartdate": "201310", "drugenddateformat": "102", "drugenddate": "20131127" }, { "drugcharacterization": "2", "medicinalproduct": "BEMETSON", "drugdosagetext": "CEREME", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20141203", "drugenddateformat": "102", "drugenddate": "20141216" }, { "drugcharacterization": "2", "medicinalproduct": "TRIMOPAN (FINLAND)", "drugdosagetext": "160 MG X 2", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20150603", "drugenddateformat": "102", "drugenddate": "20150605" }, { "drugcharacterization": "2", "medicinalproduct": "LANTUS", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20151119", "drugenddateformat": "102", "drugenddate": "20160506", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2220", "0088-2219" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "DOCETAXEL.", "drugstructuredosagenumb": "160", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "3", "drugintervaldosagedefinition": "803", "drugdosagetext": "ON 11/JUL/2013, LAST DOSE OF DOCETAXEL PRIOR TO FIRST EPISODE OF DIARRHEA?ON 01/AUG/2013, SHE RECEIV", "drugadministrationroute": "042", "drugindication": "HER-2 POSITIVE BREAST CANCER", "drugstartdateformat": "102", "drugstartdate": "20130711", "drugenddateformat": "102", "drugenddate": "20131025", "actiondrug": "6", "activesubstance": { "activesubstancename": "DOCETAXEL" }, "openfda": { "application_number": [ "ANDA207252", "ANDA215744", "NDA022234", "ANDA204490", "ANDA213510", "NDA203551", "NDA201525", "ANDA213768", "NDA215813", "ANDA210848", "ANDA210072", "ANDA208859", "ANDA214575", "ANDA209640", "ANDA204193", "NDA020449", "NDA201195", "ANDA216677", "NDA218711", "ANDA208137", "NDA022534" ], "brand_name": [ "DOCETAXEL", "DOCIVYX", "BEIZRAY" ], "generic_name": [ "DOCETAXEL", "DOCETAXEL ANHYDROUS" ], "manufacturer_name": [ "Jiangsu Hengrui Pharmaceuticals Co., Ltd.", "Baxter Healthcare Corporation", "Hospira, Inc.", "Hikma Pharmaceuticals USA Inc.", "Gland Pharma Limited", "Actavis Pharma, Inc.", "Alembic Pharmaceuticals Limited", "Meitheal Pharmaceuticals Inc.", "Avyxa Pharma, LLC", "Sagent Pharmaceuticals", "Mylan Institutional LLC", "Eugia US LLC", "Amneal Pharmaceuticals LLC", "Dr. Reddy's Laboratories Inc.", "Alembic Pharmaceuticals Inc.", "Sanofi-Aventis U.S. LLC", "Accord Healthcare Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Sandoz Inc.", "Zydus Pharmaceuticals USA Inc.", "Zhuhai Beihai Biotech Co., Ltd.", "Sun Pharmaceutical Industries, Inc." ], "product_ndc": [ "57884-3041", "57884-3042", "57884-3043", "43066-044", "43066-046", "43066-048", "0409-0365", "0409-4235", "0409-5068", "0143-9204", "0143-9205", "68083-399", "68083-400", "68083-401", "45963-734", "45963-765", "43066-001", "43066-006", "43066-010", "46708-678", "71288-133", "71288-152", "83831-101", "83831-102", "83831-103", "25021-254", "72078-040", "72078-086", "72078-087", "0409-0366", "0409-0367", "0409-0368", "55150-378", "55150-379", "55150-380", "0409-1732", "0409-7870", "67457-531", "67457-532", "67457-533", "70121-1221", "70121-1222", "70121-1223", "43598-258", "43598-259", "43598-389", "62332-678", "0955-1020", "0955-1021", "0955-1022", "16729-267", "16729-231", "25021-245", "0409-0201", "43598-610", "43598-611", "23155-903", "23155-904", "23155-905", "66758-050", "70710-2091", "70710-2093", "70710-2152", "70710-2092", "0409-0016", "0409-2026", "83513-008", "83513-009", "67457-781", "47335-323", "47335-895", "47335-939" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "DOCETAXEL", "DOCETAXEL ANHYDROUS" ], "rxcui": [ "1860480", "1860485", "1861411", "1093280", "1860619", "1001405", "2679779", "2679784", "2679786", "2679787", "2679788", "2054168", "2054170", "2697044", "2723663", "2723664", "2723665", "2723666", "2728902" ], "spl_id": [ "05e0099c-4a6e-4ca4-e063-6394a90ae073", "654319ae-e5f9-4a6a-b566-201923153b6e", "0eff97af-e2cd-46d7-84d3-0445a0910b1a", "5e524fd3-4dc2-4a16-b069-7790c57fcb72", "98672249-02db-4f71-9b49-a76e3ef56a21", "0bc8d3b7-f15e-4dbf-b51f-8baaa93b0e61", "ea75a39e-4a14-4785-b276-5094b5af1a35", "682a0b1a-3277-4718-a94e-9645633062bf", "bf235693-ce1a-4f89-b33a-8aaf93efb275", "6d914dea-626d-4402-8fce-29760fd0e34f", "841e3024-e160-4c4b-93d3-1e79d628d95b", "3eb46e06-aabe-42b6-ac06-057bca6e0d38", "297f1202-b539-41ee-bf52-4b9b04dd3a60", "5e93df13-7250-47d5-9638-0c162252aea4", "5b12d54f-e7fd-4369-afb3-431f6f08ec76", "aa6fbb17-6b11-4cc2-9798-edf1e4befd47", "350853a3-6178-4d83-b5c4-75b3e4c1799d", "b06584c8-f4fd-46dd-a1f2-0e3672b24938", "59e116c8-6ba0-4459-b71b-75ad9492ff14", "7c9667b2-3981-4256-a6a5-0c862549f837", "1fbda3cb-1ba1-490d-e063-6294a90a6777", "3897fe0d-2b9f-4be0-9076-9ccd693d4c86", "09b23b47-fb31-434b-9ad5-9bae9303933b", "948f7c4c-6a40-d240-3eb3-d9ae6e371429", "459836aa-017b-4ba5-a69d-d16824f719fd", "4142deb5-9110-4cb8-8319-8a9f1cd04647", "4efe8f3a-a176-4b69-90c8-5ba5891dccfd", "8156a5f8-7002-479d-a08d-3c68f92c1396", "45f7d427-0830-1612-e063-6294a90a04d2", "fea50522-6e4c-4ae0-81ac-53863693cc06", "9a0d7b91-4324-4e19-9cd8-eb19266e771a" ], "spl_set_id": [ "e488100d-6728-4f44-9282-f63a805b8e13", "654319ae-e5f9-4a6a-b566-201923153b6e", "6b9999bb-869e-4d25-838c-23c3ab280044", "ff7fb2c2-97a7-4716-a269-925ca30cf0f1", "14cbd8f6-e11b-4d64-aa4c-e70a2ecbf975", "2c806400-5fdc-4398-8475-37f700b3191f", "0e0f06bd-d190-45da-be8b-062e8de01970", "682a0b1a-3277-4718-a94e-9645633062bf", "f970e352-3d43-4cc4-a859-503ec37b6e22", "4763744e-360e-4d37-be05-cce4114548cd", "6b227144-c844-4549-960c-cc3ac5c13b2b", "2992d633-08fa-44f3-b14d-41700f24686b", "3104aab1-cd6e-4ad2-8e0a-286a0c5d1940", "1263799c-13dc-488b-b158-b834736a4e66", "644c5035-20d2-4686-beaa-bef08e99051c", "2fb017fd-e55e-43ef-9024-07f2d412b37b", "67508df6-b96f-46fa-a792-0afcdfa9810e", "a630937b-8369-74ad-b68a-f940eb16ff0f", "3a49c281-8cfd-4698-a9df-90ba800058ef", "dd0ca36d-1f54-4568-8d19-a7152addcd52", "f59f7811-70b7-4c44-99f7-4f4fdce3ed22", "30077f79-341f-4618-9ec5-23b17b212fae", "a0ec4bcc-93ea-4c41-a4b6-95ec19491807", "be3df07d-ea56-453a-25ad-c3cedc22712a", "81686d37-a13f-46e2-b439-a84eb1433634", "e03d1378-6889-43d5-a34c-f96132cffa88", "8fb7d980-d6c7-468b-a9f0-adff16101a4b", "00c61d11-d6b7-4618-b6f6-2592dbcc8af7", "3538b979-8cac-49ed-b8dc-50f73ce38c72", "a6417655-9448-4886-ba03-f57f36bcbd14", "c85b2c62-3c33-4cbc-8b79-d5e17851a1b4" ], "package_ndc": [ "57884-3041-1", "57884-3042-1", "57884-3043-1", "43066-044-01", "43066-044-02", "43066-046-01", "43066-046-08", "43066-048-01", "43066-048-16", "0409-4235-01", "0409-5068-01", "0409-0365-01", "0143-9204-01", "0143-9205-01", "68083-399-01", "68083-400-01", "68083-401-01", "45963-734-54", "45963-765-52", "43066-001-01", "43066-006-01", "43066-010-01", "46708-678-02", "46708-678-08", "46708-678-16", "71288-133-01", "71288-152-04", "83831-101-02", "83831-102-08", "83831-103-16", "25021-254-08", "25021-254-16", "72078-086-02", "72078-040-08", "72078-087-16", "0409-0366-01", "0409-0367-01", "0409-0368-01", "55150-378-01", "55150-379-01", "55150-380-01", "0409-7870-01", "0409-1732-01", "67457-531-02", "67457-532-08", "67457-533-16", "70121-1221-1", "70121-1222-1", "70121-1223-1", "43598-258-11", "43598-259-40", "43598-389-57", "62332-678-02", "62332-678-08", "62332-678-16", "0955-1021-04", "0955-1020-01", "0955-1022-08", "16729-231-65", "16729-231-64", "16729-231-63", "16729-267-63", "16729-267-64", "16729-267-65", "25021-245-01", "25021-245-04", "0409-0201-02", "0409-0201-10", "0409-0201-20", "43598-611-11", "43598-610-40", "23155-903-31", "23155-904-31", "23155-905-31", "66758-050-01", "66758-050-02", "66758-050-03", "70710-2091-3", "70710-2090-1", "64208-2512-4", "70710-2093-4", "70710-2152-1", "70710-2092-8", "0409-2026-01", "0409-0016-01", "83513-009-01", "83513-008-01", "67457-781-08", "47335-323-40", "47335-895-40", "47335-939-40" ], "unii": [ "15H5577CQD", "699121PHCA" ], "nui": [ "N0000175085", "N0000175592" ], "pharm_class_pe": [ "Microtubule Inhibition [PE]" ], "pharm_class_epc": [ "Microtubule Inhibitor [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ESOMEPRAZOLE", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20131003", "drugenddateformat": "102", "drugenddate": "20140601", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE" }, "openfda": { "application_number": [ "ANDA207193", "ANDA212866", "ANDA208511", "ANDA212507" ], "brand_name": [ "KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM", "ESOMEPRAZOLE MAGNESIUM", "ESOMEPRAZOLE", "DG HEALTH ESOMEPRAZOLE MAGNESIUM", "LEADER ESOMEPRAZOLE MAGNESIUM", "GOOD NEIGHBOR PHARMACY ESOMEPRAZOLE MAGNESIUM", "EQUATE ESOMEPRAZOLE MAGNESIUM", "SIGNATURE CARE ESOMEPRAZOLE MAGNESIUM", "BASIC CARE ESOMEPRAZOLE MAGNESIUM", "GOOD SENSE ESOMEPRAZOLE MAGNESIUM", "MEMBERS MARK ESOMEPRAZOLE MAGNESIUM", "EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM", "UP AND UP ESOMEPRAZOLE MAGNESIUM", "CAREONE ESOMEPRAZOLE MAGNESIUM", "BERKLEY AND JENSEN HEARTBURN TREATMENT", "FOSTER AND THRIVE ACID REDUCER", "RIOPAN" ], "generic_name": [ "ESOMEPRAZOLE", "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Costco Wholesale Company", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "INNOVUS PHARMACEUTICALS, INC.", "Dolgencorp, LLC", "YYBA CORP", "Macleods Pharmaceuticals Limited", "Cardinal Health 110, LLC. dba Leader", "Amerisource Bergen", "CVS Pharmacy", "Wal-Mart Stores Inc", "HyVee Inc", "Dolgencorp Inc", "Safeway", "H E B", "VALU MERCHANDISERS COMPANY", "THE KROGER COMPANY", "Amazon.com Services LLC", "Rite Aid Corporation", "L. Perrigo Company", "Sam's West Inc", "CVS", "Army & Air Force Exchange Service", "Target Corporation", "Safeway, Inc.", "American Sales Company", "Walgreen Company", "HARRIS TEETER", "Ohm Laboratories Inc.", "Publix Super Markets Inc", "Meijer, Inc.", "BJWC", "Meijer Distribution Inc", "Strategic Sourcing Services LLC", "OPMX LLC", "Kroger Company", "WALMART INC." ], "product_ndc": [ "63981-898", "51316-220", "57483-900", "55910-250", "73581-013", "33342-306", "33342-307", "70000-0727", "46122-641", "69842-898", "49035-921", "42507-898", "55910-593", "21130-714", "37808-719", "21130-088", "63941-999", "30142-989", "55910-640", "72288-700", "11822-0024", "72288-898", "0113-0651", "11822-0898", "68196-898", "51316-715", "55301-898", "11673-898", "0113-2022", "21130-926", "41520-727", "0363-7223", "72036-982", "51660-027", "56062-898", "79481-0411", "68391-898", "72288-560", "0113-0898", "41250-900", "70677-1099", "69729-791", "30142-273", "79903-419" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE", "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE", "ESOMEPRAZOLE MAGNESIUM" ], "rxcui": [ "606726", "606730", "433733" ], "spl_id": [ "7eb4e2fc-b372-464a-b0aa-d63d52c6717e", "ff0d65ca-7ca9-4689-b5f9-1065402c91b2", "8f25bf5e-bf0d-413e-8f91-d3537939592b", "3924ab5d-59a4-41c0-9ff8-b03ac6dd317a", "43f3c680-d4a7-5094-e063-6394a90a6ef0", "d68c9247-91c7-4e0f-adc4-2cfa7446580f", "70bfe4f8-4dba-4b46-abbd-7ff48928c9d5", "855c9137-5be7-405e-82af-61c6cd8ed401", "49ebfeb6-d3ff-4eca-a18b-6c54d6dae782", "d4a545cc-a934-4205-97e0-ceb4550d86d1", "320a5a94-ab7d-4d44-9201-b73e7aab50e5", "1c810178-5b0b-4390-bf2e-ee36839b2617", "f00018f1-772f-4ac0-a1fe-41c1f59c15f0", "e03b4775-6fd8-4d45-83e8-bc405104c539", "71c83766-70ff-401d-901a-41f66ed26f55", "2bac9451-0cc9-49a4-ad53-5ca6648a64ce", "d1f98f06-8779-4753-af5f-b45fffea3d92", "d5a842f3-d21b-4ddf-87f1-e44daf5cfe05", "4df7a0fa-f656-49a8-85fb-2ad2ee20bf28", "8fc50397-c8e2-4b2b-9fd6-8ad14f6a3fd6", "2eb11ddf-dd57-441d-beb9-23690187f152", "d4793305-cd87-49cc-b1b1-7c891c986d88", "aea67549-d9d2-4431-8973-a5b6a6909a03", "566fb836-800f-4bbc-baf0-5ae366d06d55", "3ed41fde-979d-6204-e063-6394a90ad1c1", "1ee6f7c0-dff3-4372-a901-c2adef3902b1", "77452ea9-bfd7-426f-9a66-1f5f759b4295", "674a7792-7ba0-4a78-acd3-0dfcde8128d5", "8b9a5e10-02a5-4a3d-a4c2-83ca4e47c02d", "96c2b7f1-ae2c-4b41-b58a-183b654a70ff", "1b5303d0-8b4e-4420-b976-03ba683923db", "97ef0c76-1b40-4263-9ec0-eba9a9f3d454", "53a1652c-a8b0-ed15-e063-6394a90a0a6b", "dd61324d-e918-43f2-8c65-ddbdf7102fee", "aee69f51-77b9-48c9-8de3-2aa42dc88125", "ef5ff944-86d5-487c-86df-e255793a9f52", "0c2ceff8-ed3a-425c-8cd7-22600d26406a", "34b0e9f8-27ec-49a8-a373-2a43ce42861d", "bda89e2d-5798-402f-9ddb-c8f4d7fc9140", "5c410f5e-26ec-470a-93cb-9be23e33e788", "4dc7f12f-7e83-aca2-e063-6294a90ac1dc", "a0b2b851-7ffd-4143-a57b-0d4f18902268", "4adcde28-8101-4dc3-88e6-c78ba95fc746" ], "spl_set_id": [ "4a87d5d5-c98b-4dc5-81be-50183342b047", "19fa87e4-8225-4969-9857-1bf43db4427b", "b3d10f0b-52af-408c-9b3d-f8f25f7c42bd", "8f974698-ce9c-4ffb-b77e-9bad2c2ee2a1", "0912d311-e26c-479d-9f13-ef0ac403e9b8", "d68c9247-91c7-4e0f-adc4-2cfa7446580f", "c9472b82-d345-4531-bf07-bd55c94876ab", "b596055c-98b2-47b1-b174-ae7ad3ba97ee", "6f1d75c1-3c0d-41c2-a625-1ee1bf642c32", "aaafc536-f846-4019-a629-b52b3f36e682", "b0968243-171e-428a-b692-740e0c05a0fc", "2b0e555d-3ed5-4ec4-82a6-855351c503b3", "972bb479-7146-454d-ace4-f9314f0e584e", "0d08dd06-8df6-43ff-9033-8eebd215bec1", "238b27e3-6993-4213-b7eb-062309398d1b", "ab83bbdd-2c8e-46bd-b39e-69199e004be4", "7fa75bbe-5b9f-49ca-84de-f80e5a858de4", "d5a842f3-d21b-4ddf-87f1-e44daf5cfe05", "0b115351-318c-4bd9-935c-704a09bcdf52", "c55a4f7a-3b24-47e5-8ade-3b13df003301", "2466913b-7292-4dfd-8ac9-429256faacee", "e54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec", "6996642f-a63e-4be9-aefd-0634e9914c2b", "87913038-4b90-40a0-bce5-2d368bd5758c", "b68035d0-195a-41e8-9928-8b1bd57917c0", "5fa9089f-90d1-48b6-bb79-c6171eeeaa03", "717e5d5b-4bf7-415e-b259-44056bc96d8b", "f13088de-6841-453e-acb0-08bbdf9529d1", "7c497204-29ce-45e0-84d4-91b981c9b7aa", "3f9a2747-8afd-4898-bbfb-5f379293137e", "d6a55d37-c53b-4451-859b-4dbe1988eb9d", "ea9ef7b0-7397-470f-b852-397e8b0e66e4", "e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4", "60554fd6-96d5-4e73-b676-332116caa800", "8799c88f-dafb-4be6-b279-a54d916162fe", "2369c948-d46f-4ace-bc51-47477631bc43", "42dd2e93-776c-4f49-b590-afc7dab6ef2f", "4a89b4b5-5c42-44ee-98a9-e26a237aaef7", "126c269b-260d-40f4-879d-169c09251c67", "32933772-c0ef-46ad-84e5-d70218bcc866", "4c37280d-25b6-ad2f-e063-6394a90a0b9d", "da02c079-ed18-4896-896d-0489c8f43554", "ce5f2915-327d-4a91-b7fd-e399664a250f" ], "package_ndc": [ "63981-898-01", "63981-898-03", "51316-220-01", "51316-220-03", "57483-900-42", "55910-250-01", "55910-250-02", "55910-250-03", "73581-013-42", "33342-306-07", "33342-306-10", "33342-307-07", "33342-307-10", "70000-0727-2", "70000-0727-1", "46122-641-63", "46122-641-04", "69842-898-01", "69842-898-02", "69842-898-03", "49035-921-01", "49035-921-02", "49035-921-03", "49035-921-14", "49035-921-28", "49035-921-42", "42507-898-00", "42507-898-42", "55910-593-01", "55910-593-02", "55910-593-03", "21130-714-01", "21130-714-03", "37808-719-01", "37808-719-03", "21130-088-01", "21130-088-02", "21130-088-03", "63941-999-42", "63941-999-14", "30142-989-14", "30142-989-28", "55910-640-01", "72288-700-01", "72288-700-03", "11822-0024-5", "11822-0024-7", "72288-898-01", "72288-898-03", "0113-0651-01", "0113-0651-02", "0113-0651-03", "11822-0898-1", "11822-0898-2", "11822-0898-3", "68196-898-01", "68196-898-03", "51316-715-42", "51316-715-28", "51316-715-14", "55301-898-01", "55301-898-03", "11673-898-01", "11673-898-03", "0113-2022-01", "0113-2022-02", "21130-926-42", "21130-926-28", "21130-926-14", "41520-727-01", "41520-727-03", "41520-727-02", "0363-7223-03", "0363-7223-01", "72036-982-42", "51660-027-44", "51660-027-27", "51660-027-14", "56062-898-01", "56062-898-02", "56062-898-03", "79481-0411-1", "79481-0411-0", "68391-898-00", "68391-898-03", "72288-560-01", "72288-560-03", "0113-0898-01", "0113-0898-02", "0113-0898-03", "41250-900-01", "41250-900-02", "41250-900-03", "70677-1099-1", "70677-1099-2", "70677-1099-3", "69729-791-14", "30142-273-01", "30142-273-03", "79903-419-14", "79903-419-42" ], "nui": [ "N0000175525", "N0000000147", "N0000182140" ], "pharm_class_epc": [ "Proton Pump Inhibitor [EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "N3PA6559FT", "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISOLON", "drugdosagetext": "10-40MG", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130627", "drugenddateformat": "102", "drugenddate": "20130720", "activesubstance": { "activesubstancename": "PREDNISOLONE" } }, { "drugcharacterization": "2", "medicinalproduct": "SPORANOX", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20170326", "drugenddateformat": "102", "drugenddate": "20170401", "activesubstance": { "activesubstancename": "ITRACONAZOLE" }, "openfda": { "application_number": [ "NDA020083" ], "brand_name": [ "SPORANOX" ], "generic_name": [ "ITRACONAZOLE" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-290" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ITRACONAZOLE" ], "rxcui": [ "311204", "833164" ], "spl_id": [ "a79c080b-711a-4a15-af92-ff0c60cbfdf1" ], "spl_set_id": [ "a4d555fa-787c-40fb-bb7d-b0d4f7318fd0" ], "package_ndc": [ "50458-290-01", "50458-290-04", "50458-290-28" ], "nui": [ "N0000175487", "M0002083", "N0000182141", "N0000185503", "N0000190113" ], "pharm_class_epc": [ "Azole Antifungal [EPC]" ], "pharm_class_cs": [ "Azoles [CS]" ], "pharm_class_moa": [ "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]" ], "unii": [ "304NUG5GF4" ] } }, { "drugcharacterization": "2", "medicinalproduct": "XGEVA", "drugstructuredosagenumb": "120", "drugstructuredosageunit": "003", "drugadministrationroute": "065", "drugindication": "PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20130913", "activesubstance": { "activesubstancename": "DENOSUMAB" }, "openfda": { "application_number": [ "BLA125320" ], "brand_name": [ "XGEVA" ], "generic_name": [ "DENOSUMAB" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "DENOSUMAB" ], "rxcui": [ "1046398", "1046402" ], "spl_id": [ "3ce47aaf-105d-4615-9320-1f378a9d8d84" ], "spl_set_id": [ "628f0998-1206-4001-aeee-18133aa9f3bf" ], "package_ndc": [ "55513-730-01", "55513-730-21" ], "nui": [ "N0000187055", "N0000187054" ], "pharm_class_epc": [ "RANK Ligand Inhibitor [EPC]" ], "pharm_class_moa": [ "RANK Ligand Blocking Activity [MoA]" ], "unii": [ "4EQZ6YO2HI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATARAX", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugdosagetext": "HYDROCHLORIDE", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130810", "drugenddateformat": "102", "drugenddate": "20130810", "activesubstance": { "activesubstancename": "HYDROXYZINE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "NEULASTA", "drugadministrationroute": "058", "drugstartdateformat": "102", "drugstartdate": "20130712", "drugenddateformat": "102", "drugenddate": "20130801", "activesubstance": { "activesubstancename": "PEGFILGRASTIM" }, "openfda": { "application_number": [ "BLA125031" ], "brand_name": [ "NEULASTA" ], "generic_name": [ "PEGFILGRASTIM" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-099", "55513-192", "55513-190" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "PEGFILGRASTIM" ], "rxcui": [ "727539", "727542", "2549331", "2549333", "2739503", "2739504" ], "spl_id": [ "0a35b49f-339b-4651-829a-4e84fb3a0759" ], "spl_set_id": [ "fdfe5d72-6b80-435a-afa4-c5d74dd852ce" ], "package_ndc": [ "55513-192-01", "55513-190-01", "55513-099-01" ], "nui": [ "M0024696", "N0000009451", "N0000175666" ], "pharm_class_cs": [ "Granulocyte Colony-Stimulating Factor [CS]" ], "pharm_class_pe": [ "Increased Myeloid Cell Production [PE]" ], "pharm_class_epc": [ "Leukocyte Growth Factor [EPC]" ], "unii": [ "3A58010674" ] } }, { "drugcharacterization": "2", "medicinalproduct": "V-PEN", "drugdosagetext": "3 MILLION IU", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20170503", "drugenddateformat": "102", "drugenddate": "20170509" }, { "drugcharacterization": "1", "medicinalproduct": "PERTUZUMAB.", "drugbatchnumb": "1107453,1149278,1122401,1107242,110", "drugauthorizationnumb": "125409", "drugstructuredosagenumb": "840", "drugstructuredosageunit": "003", "drugdosagetext": "LOADING DOSE", "drugdosageform": "SOLUTION FOR INFUSION", "drugadministrationroute": "042", "drugindication": "HER-2 POSITIVE BREAST CANCER", "drugstartdateformat": "102", "drugstartdate": "20130711", "drugenddateformat": "102", "drugenddate": "20130711", "actiondrug": "4", "activesubstance": { "activesubstancename": "PERTUZUMAB" }, "openfda": { "application_number": [ "BLA125409" ], "brand_name": [ "PERJETA" ], "generic_name": [ "PERTUZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-145" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "PERTUZUMAB" ], "rxcui": [ "1298948", "1298953" ], "spl_id": [ "dfebfe9c-a0c5-41d8-bf11-ed643627e264" ], "spl_set_id": [ "17f85d17-ab71-4f5b-9fe3-0b8c822f69ff" ], "package_ndc": [ "50242-145-01" ], "nui": [ "N0000175661", "N0000020008" ], "pharm_class_epc": [ "HER2/neu Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "HER2/Neu/cerbB2 Antagonists [MoA]" ], "unii": [ "K16AIQ8CTM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OPAMOX", "drugadministrationroute": "065", "drugindication": "ANXIETY", "drugstartdateformat": "102", "drugstartdate": "20130611", "activesubstance": { "activesubstancename": "OXAZEPAM" } }, { "drugcharacterization": "2", "medicinalproduct": "LOPERAMIDE", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20130622", "activesubstance": { "activesubstancename": "LOPERAMIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "GRANISETRON", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20130711", "activesubstance": { "activesubstancename": "GRANISETRON" }, "openfda": { "application_number": [ "NDA022445", "ANDA078096", "NDA022198" ], "brand_name": [ "SUSTOL", "GRANISETRON", "SANCUSO" ], "generic_name": [ "GRANISETRON", "GRANISETRON HYDROCHLORIDE" ], "manufacturer_name": [ "Heron Therapeutics, Inc.", "Fresenius Kabi USA, LLC", "Cumberland Pharmaceuticals Inc." ], "product_ndc": [ "47426-101", "63323-318", "63323-319", "63323-317", "66220-637" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS", "TRANSDERMAL" ], "substance_name": [ "GRANISETRON", "GRANISETRON HYDROCHLORIDE" ], "rxcui": [ "1810484", "1810489", "240912", "543218", "1734399", "825003", "825005" ], "spl_id": [ "7b12942e-ba3d-4921-8418-34dc5a0cb35b", "fd73c3f4-aa7d-4c2f-ab74-1883910ea086", "c78db5de-683f-41bd-8f25-700b9d0e2e46" ], "spl_set_id": [ "f7c7ffdd-8270-4030-bc1e-a1cb28a6de56", "dddc8714-383f-4bc5-a468-ae89dbc802b4", "7379369a-03df-4ec3-8f2e-66645cc736d8" ], "package_ndc": [ "47426-101-06", "47426-101-01", "63323-319-04", "63323-318-01", "63323-317-01", "66220-637-31", "66220-637-72" ], "nui": [ "N0000175817", "N0000175818" ], "pharm_class_moa": [ "Serotonin 3 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Serotonin-3 Receptor Antagonist [EPC]" ], "unii": [ "WZG3J2MCOL", "318F6L70J8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LITALGIN", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20150827", "activesubstance": { "activesubstancename": "PITOFENONE" } }, { "drugcharacterization": "2", "medicinalproduct": "VICTOZA", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20151231", "activesubstance": { "activesubstancename": "LIRAGLUTIDE" }, "openfda": { "application_number": [ "NDA022341" ], "brand_name": [ "VICTOZA" ], "generic_name": [ "LIRAGLUTIDE" ], "manufacturer_name": [ "Novo Nordisk" ], "product_ndc": [ "0169-4060" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "LIRAGLUTIDE" ], "rxcui": [ "897122", "897126" ], "spl_id": [ "0d10d10e-0fe0-47ee-b9da-628e34907e98" ], "spl_set_id": [ "5a9ef4ea-c76a-4d34-a604-27c5b505f5a4" ], "package_ndc": [ "0169-4060-13", "0169-4060-12", "0169-4060-90", "0169-4060-97", "0169-4060-98", "0169-4060-99" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "839I73S42A" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VICTOZA", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20170104", "activesubstance": { "activesubstancename": "LIRAGLUTIDE" }, "openfda": { "application_number": [ "NDA022341" ], "brand_name": [ "VICTOZA" ], "generic_name": [ "LIRAGLUTIDE" ], "manufacturer_name": [ "Novo Nordisk" ], "product_ndc": [ "0169-4060" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "LIRAGLUTIDE" ], "rxcui": [ "897122", "897126" ], "spl_id": [ "0d10d10e-0fe0-47ee-b9da-628e34907e98" ], "spl_set_id": [ "5a9ef4ea-c76a-4d34-a604-27c5b505f5a4" ], "package_ndc": [ "0169-4060-13", "0169-4060-12", "0169-4060-90", "0169-4060-97", "0169-4060-98", "0169-4060-99" ], "nui": [ "N0000178480", "M0160181", "N0000020058" ], "pharm_class_epc": [ "GLP-1 Receptor Agonist [EPC]" ], "pharm_class_cs": [ "Glucagon-Like Peptide 1 [CS]" ], "pharm_class_moa": [ "Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]" ], "unii": [ "839I73S42A" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130716" } } }, { "safetyreportversion": "55", "safetyreportid": "10269219", "primarysourcecountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20220423", "reporttype": "3", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140701", "receiptdateformat": "102", "receiptdate": "20220124", "fulfillexpeditecriteria": "1", "companynumb": "CA-ROCHE-1188671", "primarysource": { "reportercountry": "CA", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "55", "patientonsetageunit": "801", "patientweight": "53", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Upper limb fracture", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Bone disorder", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Limb mass", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Localised infection", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Osteoarthritis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Localised infection", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Peripheral swelling", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Rheumatoid arthritis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Fibromyalgia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Gastrooesophageal reflux disease", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Hernia", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Ulcer", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Foot deformity", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Rhinitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Arthropathy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Localised infection", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Nodule", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Heart rate increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Influenza", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Fall", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Cough", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Eye haemorrhage", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Oropharyngeal pain", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Sneezing", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Cough", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Hypotension", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Productive cough", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Nasopharyngitis", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Contusion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Joint swelling", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Arthralgia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Musculoskeletal stiffness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Inflammation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Disability assessment scale score increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Blood pressure systolic increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Nasopharyngitis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Lower respiratory tract infection", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Oxygen saturation decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Blood pressure diastolic abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Blood pressure fluctuation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Weight increased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Herpes zoster", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Arthralgia", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ACTEMRA", "drugbatchnumb": "B20151,B20131,B20212,B20172,B20262,", "drugauthorizationnumb": "125276", "drugstructuredosagenumb": "600", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "4", "drugintervaldosagedefinition": "803", "drugdosageform": "Infusion, Solution", "drugadministrationroute": "042", "drugindication": "Rheumatoid arthritis", "drugstartdateformat": "102", "drugstartdate": "20120202", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "openfda": { "application_number": [ "BLA125276", "BLA125472" ], "brand_name": [ "ACTEMRA" ], "generic_name": [ "TOCILIZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-135", "50242-136", "50242-137", "50242-138", "50242-143" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "TOCILIZUMAB" ], "rxcui": [ "1441527", "1441530", "1657974", "1657976", "1657979", "1657980", "1657981", "1657982", "2106073", "2106075" ], "spl_id": [ "7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a" ], "spl_set_id": [ "2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13" ], "package_ndc": [ "50242-135-01", "50242-136-01", "50242-137-01", "50242-138-01", "50242-138-86", "50242-143-01", "50242-143-86" ], "nui": [ "N0000190478", "N0000190480" ], "pharm_class_moa": [ "Interleukin 6 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Interleukin-6 Receptor Antagonist [EPC]" ], "unii": [ "I031V2H011" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ACTEMRA", "drugbatchnumb": "B20151,B20131,B20212,B20172,B20262,", "drugauthorizationnumb": "125276", "drugdosageform": "Infusion, Solution", "drugadministrationroute": "042", "drugstartdateformat": "102", "drugstartdate": "20141125", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "TOCILIZUMAB" }, "openfda": { "application_number": [ "BLA125276", "BLA125472" ], "brand_name": [ "ACTEMRA" ], "generic_name": [ "TOCILIZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-135", "50242-136", "50242-137", "50242-138", "50242-143" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "TOCILIZUMAB" ], "rxcui": [ "1441527", "1441530", "1657974", "1657976", "1657979", "1657980", "1657981", "1657982", "2106073", "2106075" ], "spl_id": [ "7f1b03d3-e0e1-4d90-b588-bb8d3ecb154a" ], "spl_set_id": [ "2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13" ], "package_ndc": [ "50242-135-01", "50242-136-01", "50242-137-01", "50242-138-01", "50242-138-86", "50242-143-01", "50242-143-86" ], "nui": [ "N0000190478", "N0000190480" ], "pharm_class_moa": [ "Interleukin 6 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Interleukin-6 Receptor Antagonist [EPC]" ], "unii": [ "I031V2H011" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFORMIN", "drugdosageform": "Tablet", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA200690", "ANDA209674", "ANDA209313" ], "brand_name": [ "METFORMIN HYDROCHLORIDE", "METFORMIN" ], "generic_name": [ "METFORMIN", "METFORMIN ER 500 MG", "METFORMIN ER 750 MG" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Ingenus Pharmaceuticals, LLC", "Granules Pharmaceuticals Inc." ], "product_ndc": [ "0378-6001", "0378-6002", "50742-633", "50742-634", "70010-491", "70010-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "1807894", "1807917", "860975", "860981" ], "spl_id": [ "2a0bac1b-3575-4b62-a74b-07f54ba064af", "3a97a225-ff03-4d81-a2fe-7f66611cc4c1", "537f5fd2-89a1-d029-e063-6394a90a9d0e" ], "spl_set_id": [ "7e41818c-60e9-4bcf-9586-7bb8d33d5e89", "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALEVE", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "NAPROXEN SODIUM" }, "openfda": { "application_number": [ "NDA020204", "NDA021920" ], "brand_name": [ "ALEVE CAPLETS", "ALEVE CAPLETS SOFT GRIP ARTHRITIS", "ALEVE CAPLETS EASY OPEN ARTHRITIS", "ALEVE GELCAPS", "ALEVE BACK AND MUSCLE PAIN", "ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP", "ALEVE HEADACHE PAIN", "ALEVE", "ALEVE EASY OPEN ARTHRITIS", "ALEVE EASY OPEN ARTHRITIS CAP" ], "generic_name": [ "NAPROXEN SODIUM", "NAPROXEN SODIUM TABLET" ], "manufacturer_name": [ "Bayer HealthCare LLC.", "Lil' Drug Store Products, Inc" ], "product_ndc": [ "0280-0114", "0280-0115", "0280-0130", "0280-6020", "0280-0111", "0280-6050", "0280-6070", "0280-0112", "0280-6010", "0280-0113", "0280-0131", "66715-6402", "66715-9702", "66715-6502", "66715-6411", "0280-8252", "0280-6080", "66715-5103", "0280-6091", "0280-6060", "0280-6000" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NAPROXEN SODIUM" ], "rxcui": [ "849574", "849728", "1112231", "1112233" ], "spl_id": [ "4cd9cec2-0e06-99a3-e063-6394a90a1943", "4526be49-a72d-1db7-e063-6394a90a1937", "31bae77b-42dc-94eb-e063-6294a90ad570", "3271583e-5034-ed79-e063-6294a90a0b0e", "4526b744-fa19-0f7b-e063-6394a90a916e", "31baf777-c806-21ea-e063-6394a90abbd8", "4526b265-424f-3e71-e063-6294a90a21a8", "31bad2d9-c0ba-7f20-e063-6294a90acb17", "2b10873f-6944-0eaf-e063-6294a90a7041", "3ba28e47-1293-bec7-e063-6294a90ac80a", "4526c253-b571-1d84-e063-6394a90ae3f9", "ef307cfd-6227-37cc-e053-2995a90aeba8", "4526c253-b572-1d84-e063-6394a90ae3f9", "4526be49-a72f-1db7-e063-6394a90a1937", "4526b744-fa15-0f7b-e063-6394a90a916e" ], "spl_set_id": [ "02941928-128a-2c88-e063-6294a90ac6ba", "0ad8bbb9-dd5f-4273-b085-ee3e5ed22613", "31bae77b-42dd-94eb-e063-6294a90ad570", "94f09ef7-0695-4499-83c1-95f1e42baf98", "acea54a2-5a92-428e-a778-bb4f9d676782", "31baf777-c805-21ea-e063-6394a90abbd8", "00ef5b30-71d0-4cb4-84a3-48c67d1cea2a", "31bad2d9-c0bb-7f20-e063-6294a90acb17", "abfcf13e-6eba-49e2-8ebf-459348714270", "3ba28e47-1294-bec7-e063-6294a90ac80a", "1266393e-b55e-4e34-9710-0b87209f4158", "d82586b5-c2ee-3f56-e053-2a95a90a42c4", "3b5442c6-c6e1-4df3-8cec-40bbb4ec469f", "3c0ddd25-5a9a-4628-a971-65fe2a9775b5", "a3745850-3e32-4884-b315-161bcb9996ed" ], "package_ndc": [ "0280-0115-02", "0280-0115-01", "0280-0115-03", "0280-0130-02", "0280-0130-01", "0280-0114-01", "0280-0114-02", "0280-0114-03", "0280-0114-04", "0280-0114-05", "0280-0114-08", "0280-6020-20", "0280-6020-40", "0280-6020-80", "0280-6020-16", "0280-6020-02", "0280-0111-01", "0280-0111-02", "0280-0111-03", "0280-0111-04", "0280-0111-05", "0280-0111-06", "0280-0111-07", "0280-6050-50", "0280-6050-01", "0280-6050-27", "0280-6050-02", "0280-6050-03", "0280-6050-04", "0280-6050-06", "0280-6050-05", "0280-6070-40", "0280-0112-01", "0280-0112-02", "0280-0112-03", "0280-0112-04", "0280-6010-24", "0280-6010-50", "0280-6010-01", "0280-6010-02", "0280-6010-03", "0280-6010-04", "0280-6010-06", "0280-6010-05", "0280-6010-07", "0280-6010-09", "0280-6010-10", "0280-0113-01", "0280-0113-02", "0280-0113-03", "0280-0113-04", "0280-0113-05", "0280-0113-06", "0280-0131-01", "66715-6402-8", "66715-9702-1", "66715-9702-2", "66715-9702-3", "66715-9702-0", "66715-6502-2", "66715-6411-2", "0280-8252-24", "0280-8252-10", "0280-6080-20", "0280-6080-40", "0280-6080-80", "0280-6080-16", "0280-6080-01", "0280-6080-02", "0280-6080-03", "0280-6080-04", "66715-5103-0", "0280-6091-80", "0280-6060-20", "0280-6060-25", "0280-6060-32", "0280-6000-06", "0280-6000-24", "0280-6000-50", "0280-6000-10", "0280-6000-15", "0280-6000-02", "0280-6000-27", "0280-6000-32", "0280-6000-70", "0280-6000-75", "0280-6000-01", "0280-6000-03", "0280-6000-04", "0280-6000-05", "0280-6000-07", "0280-6000-08", "0280-6000-12", "0280-6000-09", "0280-6000-16" ], "unii": [ "9TN87S3A3C" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PAXIL", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "PAROXETINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA020936", "NDA020031" ], "brand_name": [ "PAXIL CR", "PAXIL" ], "generic_name": [ "PAROXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Apotex Corp" ], "product_ndc": [ "60505-4377", "60505-4378", "60505-4379", "60505-3668", "60505-3669", "60505-3670", "60505-4517", "60505-4518", "60505-4519", "60505-4520" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PAROXETINE HYDROCHLORIDE" ], "rxcui": [ "1738803", "1738804", "1738805", "1738806", "1738807", "1738808", "207349", "207350", "211699", "211700", "1738483", "1738495", "1738503", "1738511" ], "spl_id": [ "57998b73-87c9-7fed-ffa8-7e43620bd98a", "62b4ffe1-48e2-6dd5-d7ca-28e8efe36686" ], "spl_set_id": [ "483bd97f-c4d0-4e23-aaa8-6334f4471e0c", "ef3b5cbe-f9e1-c1ac-79da-cfe14e3a7e7e" ], "package_ndc": [ "60505-4377-3", "60505-4378-3", "60505-4379-3", "60505-3668-3", "60505-3669-3", "60505-3670-3", "60505-4517-3", "60505-4518-3", "60505-4519-3", "60505-4520-3" ], "unii": [ "X2ELS050D8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RABEPRAZOLE SODIUM", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "RABEPRAZOLE SODIUM" }, "openfda": { "application_number": [ "ANDA208644", "ANDA205761", "ANDA204237", "NDA020973", "ANDA202376", "ANDA090678", "ANDA204179" ], "brand_name": [ "RABEPRAZOLE SODIUM", "ACIPHEX" ], "generic_name": [ "RABEPRAZOLE SODIUM", "RABEPRAZOLE" ], "manufacturer_name": [ "Ascend Laboratories, LLC", "Aurobindo Pharma Limited", "Advagen Pharma Limited", "Waylis Therapeutics LLC", "Torrent Pharmaceuticals Limited", "Lannett Company, Inc.", "Amneal Pharmaceuticals LLC", "Chartwell RX, LLC" ], "product_ndc": [ "67877-443", "65862-721", "72888-059", "80725-243", "13668-107", "62175-302", "65162-724", "62135-503" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RABEPRAZOLE SODIUM" ], "rxcui": [ "854868", "854870" ], "spl_id": [ "f3b11232-76f6-4cfd-84ac-73df3fa0d3a4", "3a12547f-7c57-44f8-a6bb-d3287701033f", "4844a51a-513a-8b72-e063-6294a90ab996", "cc6cb214-ac28-4c8b-9b57-7635ef896038", "cd95d6fc-099e-4ba3-98f1-b30a2301c268", "dde0e5ce-043b-4ada-aa94-eab41e41bc17", "f02b0373-dbac-4842-bf97-3352b8c74089", "45adfadd-b711-a916-e063-6394a90ac34c" ], "spl_set_id": [ "45092108-7c4a-48f9-8222-ca8612e82189", "d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89", "b1a12c83-74ab-febc-e053-2a95a90a1441", "1eb38279-0237-4967-be7a-c53a826c1138", "04e88b86-e1dd-4c56-8359-45fbcc161f7d", "7f7d68f0-972b-4315-b712-0bb8a84c85cc", "951caefe-6e18-48ff-9567-beb545b09c25", "c5c43222-d167-4152-b5c7-84b55920a7ce" ], "package_ndc": [ "67877-443-30", "67877-443-90", "67877-443-33", "67877-443-38", "65862-721-30", "65862-721-90", "72888-059-30", "72888-059-90", "80725-243-30", "13668-107-30", "13668-107-90", "62175-302-32", "62175-302-46", "62175-302-42", "62175-302-41", "62175-302-43", "65162-724-03", "65162-724-09", "65162-724-50", "65162-724-11", "62135-503-30", "62135-503-90" ], "unii": [ "3L36P16U4R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TRAZODONE", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "TRAZODONE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "METHOTREXATE", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "METHOTREXATE" }, "openfda": { "application_number": [ "ANDA210454", "NDA011719", "NDA212479", "ANDA040385", "ANDA040263", "ANDA220225", "ANDA040632", "ANDA201529", "ANDA201749", "ANDA081235", "NDA205776", "NDA208400", "ANDA040266", "ANDA040843", "ANDA207812", "ANDA081099", "ANDA040716", "ANDA089343", "ANDA089342", "ANDA089341", "ANDA089340", "ANDA213343", "ANDA217552", "NDA204824" ], "brand_name": [ "METHOTREXATE", "JYLAMVO", "TREXALL", "RASUVO", "XATMEP", "OTREXUP" ], "generic_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Chartwell RX, LLC", "Hospira, Inc.", "SHORLA ONCOLOGY INC.", "Teva Women's Health LLC", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Alembic Pharmaceuticals Limited", "Eugia US LLC", "Sun Pharmaceutical Industries, Inc.", "Mylan Pharmaceuticals Inc.", "Medexus Pharma Inc.", "Aurobindo Pharma Limited", "Azurity Pharmaceuticals, Inc.", "Teva Parenteral Medicines, Inc.", "Zydus Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc.", "Accord Healthcare, Inc.", "Zydus Lifesciences Limited", "Accord Healthcare Inc.", "Antares Pharma, Inc." ], "product_ndc": [ "62135-772", "61703-350", "61703-408", "81927-204", "51285-366", "51285-367", "51285-368", "51285-369", "63323-123", "62332-711", "62332-712", "0143-9830", "46708-711", "46708-712", "55150-510", "55150-511", "55150-512", "55150-513", "47335-235", "61703-124", "61703-161", "0378-0014", "0143-9367", "59137-505", "59137-510", "59137-515", "59137-520", "59137-525", "59137-530", "59137-535", "59137-540", "59137-550", "59651-182", "52652-2001", "63323-122", "0703-3671", "0703-3675", "0703-3678", "68382-775", "0555-0572", "16729-277", "0143-9516", "0143-9519", "0143-9518", "0143-9517", "70771-1058", "16729-486", "62332-730", "54436-010", "54436-075", "54436-012", "54436-015", "54436-017", "54436-020", "54436-022", "54436-025", "46708-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "INTRATHECAL", "INTRA-ARTERIAL" ], "substance_name": [ "METHOTREXATE SODIUM", "METHOTREXATE" ], "rxcui": [ "105585", "1655956", "1946772", "2671456", "2671462", "105586", "283510", "283511", "283671", "284592", "284593", "284594", "284595", "311625", "1655959", "1655960", "1655967", "1655968", "1441416", "1544378", "1544383", "1544385", "1544386", "1544387", "1544388", "1544389", "1544390", "1544394", "1544395", "1544396", "1544397", "1544398", "1544401", "1544402", "1544403", "1544404", "1921592", "1921598", "1441402", "1441407", "1441411", "1441413", "1441418", "1441422", "1441424", "1594757", "1594759", "1747179", "1747181", "1747185", "1747187", "1747192", "1747194" ], "spl_id": [ "462a5023-e5a1-692a-e063-6294a90a7236", "95b8b8da-da4e-4bba-9038-3cf65f3d5c1a", "37b3e76b-ac3d-4f93-adf1-91f52f676b8a", "53bd9776-70ec-46f9-e063-6294a90a7011", "d1e7432e-253d-49f0-ab0a-bb859210ccd6", "880c2caa-1b11-45ce-a54e-a3733da367f0", "91ce9c78-370f-49a1-ae22-428bdddb389f", "49eb25b2-c59c-4374-a216-076767fe1126", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "524f657e-d138-9c87-e063-6294a90a93ad", "6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "01ad6cb9-5879-4c06-801b-0de84eebaae7", "7950579c-084b-472b-a7ce-f342691aff97", "29d04017-dd64-4dea-a064-7b3b0805f423", "9fe03573-fff3-4051-8598-8542eee1273f", "4e3b0925-2cdc-4743-91cf-860d98dd4661", "3d21237a-ef53-4592-bf06-0c739696203d", "e81074cc-12b4-4ac9-a5bb-749188989b2c", "5d9b7269-19d4-4d2c-b252-f3ff759dffa5", "9c7cf5a6-e720-4e83-bb08-f371e9bb9c9e", "2bae3cfe-7aa0-c14c-e063-6294a90a19f4", "3046ff78-3565-46d1-a88b-283e5ff6e7c3", "ae399908-cfb6-44dc-83da-8981f5dabbb8", "52d366f6-f339-ff1a-e063-6294a90a1577", "9dd138d6-6889-400e-a994-9931af68244a", "2d07eb50-d314-a6a0-e063-6394a90ac970", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "spl_set_id": [ "2609da8f-80dc-448e-8eba-35d11488ce7f", "0d63ba29-b692-41b4-87e8-351265c8273f", "0e30eaef-5a09-4104-8a11-c32933eadeab", "96e931f5-51ae-4bdf-a441-bb0dd26d4c0e", "e942f8db-510f-44d6-acb5-b822196f5e8c", "b585f621-f6c9-4735-ab61-bd1b401f3df0", "a63364d5-4dfa-49d7-8a5e-c8959ae1d37a", "b080eb92-fc72-4ce6-a7ab-3f9ce2415526", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "63bb6fbf-dd59-4edc-af8f-d0c397ca1262", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "bd287e89-32f9-4396-95fa-4b562869f476", "70c09984-2b36-424f-8b27-3fd0cd4e833d", "8593f7fc-eabe-44ae-bb05-b3d7d408e4f7", "d0075461-0e7e-4967-9c9b-d6440e912c0e", "09931d44-a3f8-49dc-a3f2-b527ee4214bf", "aec9984e-34c5-481b-b6bf-9bb5caf1daf8", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "346ec9ce-dc98-4a55-b55e-d3af11f2d703", "948e0bab-6524-4b87-9853-1799d4415558", "9b34b1d8-d125-41a2-9f6f-3fab67b573bd", "dd035a9f-cd40-4314-b9d8-2294b8a924e2", "3989d30d-56e5-4e8d-9379-c30fecc894f2", "59ea7b32-2b6d-4197-92c3-015936f04ebe", "874c7f43-a3be-4236-89cc-24c44e3c5813", "04a95db9-a124-4b97-bd71-1c37a6b3b0c8", "9ab8ce16-f7de-41d4-a4c8-1c742621b6d5", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "package_ndc": [ "62135-772-35", "61703-350-37", "61703-350-38", "61703-408-41", "61703-350-09", "61703-350-10", "61703-408-25", "81927-204-01", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "63323-123-10", "62332-711-01", "62332-711-05", "62332-712-01", "0143-9830-01", "46708-711-01", "46708-711-05", "46708-712-01", "55150-510-01", "55150-510-05", "55150-511-01", "55150-511-10", "55150-512-01", "55150-512-10", "55150-513-01", "47335-235-96", "47335-235-83", "61703-124-40", "61703-161-02", "61703-161-05", "0378-0014-01", "0143-9367-01", "59137-505-00", "59137-505-01", "59137-505-04", "59137-510-00", "59137-510-01", "59137-510-04", "59137-515-00", "59137-515-01", "59137-515-04", "59137-520-00", "59137-520-01", "59137-520-04", "59137-525-00", "59137-525-01", "59137-525-04", "59137-530-00", "59137-530-01", "59137-530-04", "59137-535-00", "59137-535-01", "59137-535-04", "59137-540-00", "59137-540-01", "59137-540-04", "59137-550-00", "59137-550-01", "59137-550-04", "59651-182-36", "59651-182-01", "52652-2001-1", "52652-2001-6", "63323-122-50", "0703-3671-01", "0703-3675-01", "0703-3678-01", "68382-775-60", "68382-775-16", "68382-775-01", "68382-775-05", "68382-775-10", "68382-775-77", "0555-0572-35", "0555-0572-02", "16729-277-30", "16729-277-03", "16729-277-35", "0143-9519-10", "0143-9518-01", "0143-9517-01", "0143-9516-01", "70771-1058-3", "70771-1058-9", "70771-1058-1", "70771-1058-5", "70771-1058-0", "70771-1058-2", "70771-1058-7", "16729-486-36", "16729-486-01", "62332-730-36", "62332-730-31", "54436-075-01", "54436-075-02", "54436-075-04", "54436-010-01", "54436-010-03", "54436-010-02", "54436-010-04", "54436-012-01", "54436-012-03", "54436-012-02", "54436-012-04", "54436-015-01", "54436-015-03", "54436-015-02", "54436-015-04", "54436-017-01", "54436-017-03", "54436-017-02", "54436-017-04", "54436-020-01", "54436-020-03", "54436-020-02", "54436-020-04", "54436-022-01", "54436-022-03", "54436-022-02", "54436-022-04", "54436-025-01", "54436-025-03", "54436-025-02", "54436-025-04", "46708-730-36", "46708-730-31" ], "unii": [ "3IG1E710ZN", "YL5FZ2Y5U1" ], "nui": [ "N0000175584", "N0000000111" ], "pharm_class_epc": [ "Folate Analog Metabolic Inhibitor [EPC]" ], "pharm_class_moa": [ "Folic Acid Metabolism Inhibitors [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALENDRONATE", "activesubstance": { "activesubstancename": "ALENDRONATE SODIUM" }, "openfda": { "application_number": [ "ANDA090258" ], "brand_name": [ "ALENDRONATE" ], "generic_name": [ "ALENDRONATE SODIUM", "ALENDRONATE SODIUM TABLET" ], "manufacturer_name": [ "Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.", "Marlex Pharmaceuticals, Inc." ], "product_ndc": [ "60723-205", "60723-207", "10135-718", "10135-719" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ALENDRONATE SODIUM" ], "rxcui": [ "904396", "904431" ], "spl_id": [ "460d461d-4807-2ed0-e063-6394a90aad4a", "3e74abef-2742-2bbe-e063-6394a90a12cd" ], "spl_set_id": [ "a24fd39c-34a7-4de2-9439-781e612189ca", "b63421af-ec03-1de7-e053-2a95a90abec6" ], "package_ndc": [ "60723-205-31", "60723-205-32", "60723-205-33", "60723-207-31", "60723-207-32", "60723-207-33", "10135-718-44", "10135-718-12", "10135-719-44", "10135-719-12", "10135-719-20" ], "unii": [ "2UY4M2U3RA" ] } }, { "drugcharacterization": "2", "medicinalproduct": "JARDIANCE", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TRAZODONE", "activesubstance": { "activesubstancename": "TRAZODONE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "VENLAFAXINE", "activesubstance": { "activesubstancename": "VENLAFAXINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA215622", "ANDA211323", "ANDA206250", "ANDA078627", "ANDA078932", "ANDA090555", "NDA215429", "ANDA078554", "ANDA214127", "ANDA077653", "ANDA214609", "ANDA214419", "ANDA216044", "ANDA214691" ], "brand_name": [ "VENLAFAXINE", "VENLAFAXINE HYDROCHLORIDE" ], "generic_name": [ "VENLAFAXINE", "VENLAFAXINE HYDROCHLORIDE" ], "manufacturer_name": [ "Zydus Lifesciences Limited", "Modavar Pharmaceuticals LLC", "Cadila Pharmaceuticals Limited", "Sun Pharmaceutical Industries, Inc.", "Alembic Pharmaceuticals Inc.", "Aurobindo Pharma Limited", "Zydus Pharmaceuticals USA Inc.", "Almatica Pharma LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Rising Pharma Holdings, Inc.", "Ascend Laboratories, LLC", "Alembic Pharmaceuticals Limited", "BluePoint Laboratories", "Dr. Reddy's Laboratories Inc.", "XLCare Pharmaceuticals, Inc.", "Camber Pharmaceuticals, Inc.", "Ajanta Pharma USA Inc." ], "product_ndc": [ "70771-1649", "70771-1650", "70771-1651", "70771-1652", "72241-075", "72241-076", "72241-077", "71209-087", "71209-088", "71209-089", "71209-025", "71209-026", "71209-027", "71209-028", "71209-029", "57664-392", "57664-393", "57664-394", "57664-395", "57664-396", "62332-008", "62332-009", "62332-010", "62332-011", "62332-012", "65862-404", "65862-405", "65862-406", "65862-407", "65862-408", "70710-1348", "70710-1349", "70710-1350", "70710-1352", "52427-632", "23155-246", "23155-247", "23155-248", "23155-249", "23155-250", "57237-172", "57237-173", "57237-174", "57237-175", "57237-176", "67877-726", "67877-727", "67877-728", "67877-729", "46708-430", "46708-431", "46708-432", "46708-433", "46708-434", "68001-156", "68001-158", "68001-159", "68001-157", "68001-160", "68382-018", "68382-019", "68382-020", "68382-021", "68382-101", "43598-943", "43598-944", "72865-197", "72865-198", "72865-199", "72865-200", "68001-496", "68001-497", "68001-498", "68001-499", "31722-123", "31722-124", "31722-125", "31722-126", "64980-578", "64980-579", "64980-580", "64980-581", "27241-221", "27241-222", "27241-223", "27241-224" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VENLAFAXINE HYDROCHLORIDE", "VENLAFAXINE BESYLATE MONOHYDRATE" ], "rxcui": [ "808744", "808748", "808751", "808753", "313580", "313582", "313584", "313586", "314277", "2605950" ], "spl_id": [ "0bf02fa2-e5cd-42d6-ab41-1ecd150b7c57", "14b38374-7287-47dd-8ef9-e88bd5b23a26", "5e8d05f3-2a6f-4132-b7e3-9dc90804f2d3", "f6bcbdd6-db09-4aeb-8eb0-6eadb8ebdeba", "4a916be7-abd4-8771-e063-6394a90a86eb", "8724b94d-b3fd-4844-a7fe-2be7982cf8f5", "426d12db-50e2-4915-999f-84645fb387d9", "479c565e-3c2f-42a1-8a19-b7a210e5f28d", "1b0762be-0db0-b997-b76b-b212a496f82c", "da564fb4-3f43-4725-b5f2-e5826bfc2170", "4da7fe70-bb28-43f2-97b6-66d130e6c72f", "17943f8a-6ea6-4e86-93cc-df580774a8d9", "47576e3f-2b6d-4334-8733-748687e5b784", "04c5d11d-d249-eb93-e063-6294a90a1b46", "ea404f6c-7e07-4779-a52c-8cffb92718ef", "79d34297-6604-4031-a89a-8ec557d078d1", "2cdc9267-9619-474a-abe4-a0b85ac3fb2d", "2b5c3dc6-9055-abe9-e063-6294a90af76e", "495259b8-9f81-4b6e-aa51-d199aa0edfb8", "7f187899-ddc6-4e15-b2af-e54f59d5baf4", "a85661b9-217a-41ca-90d8-d1e29052e44d" ], "spl_set_id": [ "750333ce-a512-42e1-b9e3-179714b488df", "14b38374-7287-47dd-8ef9-e88bd5b23a26", "516e7566-35c2-4a25-88d8-54d9dbc8f6be", "2ed61dcf-42e3-47cf-a607-459eef5fea98", "55889b3d-74c9-4638-9a14-6a4ca3a99f7f", "67b323a7-a8c9-410f-bff0-0e515bef41a7", "b23637e5-d37f-41b5-ba76-fc053e903bc2", "db1d16b3-d1a2-4f41-adff-a87c17689aa0", "e81a2daf-b8b2-7c05-b532-bc775700b100", "80ac757d-c629-4579-8afd-cae0ee9cd614", "20319949-ccf9-477a-a6e3-53502772deb9", "528d5392-4ad5-48c5-963d-6ebfb9187db4", "b73da6e2-1494-436f-a204-2e4e4c5974b6", "172b3d3d-bdae-47bf-8fba-edd6da1a8649", "72efad5f-0909-46a5-aa13-ac24fe015fe6", "9312f4df-63d9-4167-880f-36a816870442", "68f40801-d35e-464e-ac94-21016b617ea2", "5efe1336-c796-4560-8110-a64c80eefb0c", "8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd3", "074f4478-e81b-45a2-ae85-ffd27bed940f", "22d4817c-1f19-4490-8a38-d8904f0374f7" ], "package_ndc": [ "70771-1649-3", "70771-1649-9", "70771-1649-1", "70771-1650-3", "70771-1650-9", "70771-1650-1", "70771-1651-3", "70771-1651-9", "70771-1651-1", "70771-1652-3", "70771-1652-9", "70771-1652-1", "72241-075-22", "72241-075-04", "72241-075-11", "72241-076-22", "72241-076-04", "72241-076-11", "72241-077-22", "72241-077-04", "72241-077-11", "71209-087-01", "71209-087-04", "71209-087-11", "71209-088-01", "71209-088-04", "71209-088-11", "71209-089-01", "71209-089-04", "71209-089-11", "71209-025-05", "71209-026-05", "71209-027-05", "71209-028-05", "71209-029-05", "57664-392-88", "57664-393-88", "57664-394-88", "57664-395-88", "57664-396-88", "62332-008-30", "62332-008-31", "62332-008-91", "62332-009-30", "62332-009-31", "62332-009-91", "62332-010-30", "62332-010-31", "62332-010-91", "62332-011-30", "62332-011-31", "62332-011-91", "62332-012-30", "62332-012-31", "62332-012-91", "65862-404-30", "65862-404-60", "65862-404-90", "65862-404-01", "65862-404-99", "65862-404-71", "65862-404-10", "65862-405-30", "65862-405-60", "65862-405-90", "65862-405-01", "65862-405-99", "65862-405-66", "65862-405-10", "65862-406-30", "65862-406-90", "65862-406-01", "65862-406-99", "65862-406-59", "65862-406-10", "65862-407-30", "65862-407-90", "65862-407-01", "65862-407-99", "65862-407-71", "65862-407-10", "65862-408-20", "65862-408-90", "65862-408-01", "65862-408-99", "65862-408-66", "65862-408-10", "70710-1348-1", "70710-1348-3", "70710-1348-9", "70710-1349-3", "70710-1349-9", "70710-1349-1", "70710-1350-3", "70710-1350-9", "70710-1350-1", "70710-1352-3", "70710-1352-9", "70710-1352-1", "52427-632-30", "23155-246-09", "23155-246-01", "23155-247-09", "23155-247-01", "23155-248-09", "23155-248-01", "23155-249-09", "23155-249-01", "23155-250-09", "23155-250-01", "57237-172-90", "57237-172-01", "57237-173-90", "57237-173-01", "57237-174-90", "57237-174-01", "57237-175-90", "57237-175-01", "57237-176-90", "57237-176-01", "67877-726-30", "67877-726-90", "67877-727-30", "67877-727-90", "67877-728-30", "67877-728-90", "67877-729-30", "67877-729-90", "46708-430-30", "46708-430-31", "46708-430-91", "46708-431-30", "46708-431-31", "46708-431-91", "46708-432-30", "46708-432-31", "46708-432-91", "46708-433-30", "46708-433-31", "46708-433-91", "46708-434-30", "46708-434-31", "46708-434-91", "68001-158-00", "68001-159-00", "68001-157-00", "68001-160-00", "68001-156-00", "68382-018-06", "68382-018-14", "68382-018-16", "68382-018-01", "68382-018-05", "68382-018-10", "68382-019-06", "68382-019-14", "68382-019-16", "68382-019-01", "68382-019-05", "68382-019-10", "68382-020-06", "68382-020-14", "68382-020-16", "68382-020-01", "68382-020-05", "68382-020-10", "68382-021-06", "68382-021-14", "68382-021-16", "68382-021-01", "68382-021-05", "68382-021-10", "68382-101-06", "68382-101-14", "68382-101-16", "68382-101-01", "68382-101-05", "68382-101-10", "43598-943-30", "43598-943-90", "43598-944-30", "43598-944-90", "72865-197-30", "72865-197-90", "72865-198-30", "72865-198-90", "72865-199-30", "72865-199-90", "72865-200-30", "72865-200-90", "68001-496-04", "68001-496-05", "68001-497-04", "68001-497-05", "68001-498-04", "68001-498-05", "68001-499-04", "68001-499-05", "31722-123-30", "31722-123-90", "31722-124-30", "31722-124-90", "31722-125-30", "31722-125-90", "31722-126-30", "31722-126-90", "64980-578-03", "64980-578-09", "64980-579-03", "64980-579-09", "64980-580-03", "64980-580-09", "64980-581-03", "64980-581-09", "27241-221-30", "27241-221-90", "27241-222-30", "27241-222-90", "27241-223-30", "27241-223-90", "27241-224-30", "27241-224-90" ], "unii": [ "7D7RX5A8MO", "18XP3YT5NH" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130101" } } }, { "safetyreportversion": "7", "safetyreportid": "10308818", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140716", "receiptdateformat": "102", "receiptdate": "20150612", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2014199359", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014199359" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientweight": "90.7", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Malaise", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Poor quality sleep", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Drug withdrawal syndrome", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Feeling jittery", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Pain", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosagetext": "300 MG, DAILY (75 MG IN MORNING, 225 MG BEDTIME)", "activesubstance": { "activesubstancename": "PREGABALIN" }, "openfda": { "application_number": [ "NDA021446", "NDA022488" ], "brand_name": [ "LYRICA" ], "generic_name": [ "PREGABALIN" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc", "Viatris Specialty LLC" ], "product_ndc": [ "0071-1018", "0071-1012", "0071-1013", "0071-1014", "0071-1015", "0071-1016", "0071-1017", "0071-1019", "0071-1020", "58151-236", "58151-237", "58151-238", "58151-239", "58151-240", "58151-241", "58151-243", "58151-242", "58151-244" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREGABALIN" ], "rxcui": [ "483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127", "607018", "607020", "607022", "607024", "607026", "607028", "607033", "607038", "898715", "898718" ], "spl_id": [ "e7c79058-03ba-4e7f-9a31-9ec5ce245161", "1c2af07d-faf4-4fc7-b724-c5166746956d" ], "spl_set_id": [ "60185c88-ecfd-46f9-adb9-b97c6b00a553", "d4734e7d-5079-455e-8ff5-8f4539c998a9" ], "package_ndc": [ "0071-1012-68", "0071-1013-41", "0071-1013-68", "0071-1014-41", "0071-1014-68", "0071-1015-41", "0071-1015-68", "0071-1016-41", "0071-1016-68", "0071-1017-68", "0071-1019-68", "0071-1018-68", "0071-1020-01", "58151-236-77", "58151-237-32", "58151-237-88", "58151-237-77", "58151-238-32", "58151-238-88", "58151-238-77", "58151-239-32", "58151-239-88", "58151-239-77", "58151-240-32", "58151-240-88", "58151-240-77", "58151-241-77", "58151-243-77", "58151-242-77", "58151-244-35" ], "unii": [ "55JG375S6M" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BYDURON", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "2 MG, WEEKLY", "drugdosageform": "INJECTION", "drugindication": "GLYCOSYLATED HAEMOGLOBIN INCREASED" }, { "drugcharacterization": "1", "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugdosagetext": "THREE ONE DAY AND FOUR THE NEXT", "drugenddateformat": "102", "drugenddate": "20150107", "activesubstance": { "activesubstancename": "PREGABALIN" }, "openfda": { "application_number": [ "NDA021446", "NDA022488" ], "brand_name": [ "LYRICA" ], "generic_name": [ "PREGABALIN" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc", "Viatris Specialty LLC" ], "product_ndc": [ "0071-1018", "0071-1012", "0071-1013", "0071-1014", "0071-1015", "0071-1016", "0071-1017", "0071-1019", "0071-1020", "58151-236", "58151-237", "58151-238", "58151-239", "58151-240", "58151-241", "58151-243", "58151-242", "58151-244" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREGABALIN" ], "rxcui": [ "483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127", "607018", "607020", "607022", "607024", "607026", "607028", "607033", "607038", "898715", "898718" ], "spl_id": [ "e7c79058-03ba-4e7f-9a31-9ec5ce245161", "1c2af07d-faf4-4fc7-b724-c5166746956d" ], "spl_set_id": [ "60185c88-ecfd-46f9-adb9-b97c6b00a553", "d4734e7d-5079-455e-8ff5-8f4539c998a9" ], "package_ndc": [ "0071-1012-68", "0071-1013-41", "0071-1013-68", "0071-1014-41", "0071-1014-68", "0071-1015-41", "0071-1015-68", "0071-1016-41", "0071-1016-68", "0071-1017-68", "0071-1019-68", "0071-1018-68", "0071-1020-01", "58151-236-77", "58151-237-32", "58151-237-88", "58151-237-77", "58151-238-32", "58151-238-88", "58151-238-77", "58151-239-32", "58151-239-88", "58151-239-77", "58151-240-32", "58151-240-88", "58151-240-77", "58151-241-77", "58151-243-77", "58151-242-77", "58151-244-35" ], "unii": [ "55JG375S6M" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METOPROLOL TARTRATE.", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "25 MG, 1X/DAY", "activesubstance": { "activesubstancename": "METOPROLOL TARTRATE" }, "openfda": { "application_number": [ "ANDA204205", "ANDA077761", "ANDA078085", "NDA219373", "ANDA200981", "ANDA077739", "ANDA078950", "ANDA091045", "ANDA202871", "NDA218698", "NDA017963", "ANDA076704" ], "brand_name": [ "METOPROLOL TARTRATE", "LOPRESSOR", "METOPROLOL" ], "generic_name": [ "METOPROLOL TARTRATE", "METOROPROLOL TARTRATE", "METOPROLOL" ], "manufacturer_name": [ "Almaject, Inc.", "Hikma Pharmaceuticals USA Inc.", "Hospira, Inc.", "VALIDUS PHARMACEUTICALS LLC", "TRUPHARMA LLC", "Exelan Pharmaceuticals, Inc.", "Aurobindo Pharma Limited", "FOSUN PHARMA USA INC", "Rising Pharma Holdings, Inc.", "Baxter Healthcare Corporation", "Advagen Pharma Limited", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "TruPharma LLC", "Sagent Pharmaceuticals", "Validus Pharmaceuticals LLC", "Gland Pharma Limited", "Civica, Inc.", "Advagen Pharma Ltd", "Mylan Pharmaceuticals Inc.", "Alembic Pharmaceuticals Limited" ], "product_ndc": [ "72611-740", "0143-9660", "0143-9873", "0409-2016", "30698-464", "52817-250", "52817-251", "52817-252", "52817-253", "52817-254", "76282-794", "76282-795", "76282-796", "59651-758", "59651-760", "72266-122", "57237-100", "57237-101", "57237-102", "36000-033", "72888-004", "72888-101", "72888-005", "72888-023", "72888-006", "63323-660", "62332-112", "62332-113", "62332-114", "65219-665", "30698-460", "52817-358", "52817-362", "52817-359", "52817-361", "52817-360", "0409-1778", "25021-303", "30698-458", "30698-459", "72888-197", "68083-131", "65862-062", "65862-063", "65862-064", "72572-420", "72888-208", "72888-209", "72888-210", "72888-211", "72888-212", "0378-0018", "0378-4593", "0378-0032", "0378-4594", "0378-0047", "46708-290", "46708-291", "46708-292" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "ORAL" ], "substance_name": [ "METOPROLOL TARTRATE" ], "rxcui": [ "866508", "2712147", "2712152", "866511", "866514", "866924", "1606347", "1606349", "2723025", "2723027", "866513", "866516" ], "spl_id": [ "ede4ae40-88e0-0536-3e01-2f2ac0b5ae3c", "6a34f3f1-4b17-4864-97ec-405fffb45f20", "99c56211-4024-48e5-b46d-840a88f4b16d", "352cee93-db0d-1c05-e063-6294a90a7533", "2261de1d-98d7-8d12-e063-6394a90a33b1", "562ee54a-9c4d-4677-9b0b-bc3bdd2809bd", "2d3b41ae-f657-4459-bdee-e76e644ec167", "53ff850a-18d5-dce4-e063-6394a90aedcd", "a688acb3-72c6-4fcf-b225-648ae694279f", "5d975af3-d078-4130-9448-ed77123f1aac", "48450d44-3cc6-45be-e063-6394a90aac70", "4066607a-15cb-42ac-999e-5254907dda5a", "c7738f42-299e-4bea-af50-778e069352f0", "ccb1a15e-c943-4042-ae46-550bdabfc96b", "494efa43-aa90-d6f4-e063-6294a90a11ac", "294dc99d-4a6d-22b6-e063-6394a90a06aa", "25fb7425-bc57-4216-8fc8-0bbec3d1125b", "b0c162ae-0af5-4443-9136-edf762c90e11", "28c4fc69-5609-49ec-8fe5-4d7bc8f88288", "4984fefe-6924-2aa6-e063-6394a90a1853", "32f3e39e-0df1-4cd0-96f1-14d69d7b827d", "d265c99d-8e77-4a78-b542-15e957d9d335", "b7f91aa3-7359-4903-91d5-57e73f6cfc0a", "3e9a73a5-7f4a-1caa-e063-6394a90a89bc", "57d60035-d408-4f98-932e-2cbbeae5326c", "f31d2aef-f902-4984-803c-5bdb015e9253" ], "spl_set_id": [ "f0370951-ab26-d4d1-b857-57518f3c4175", "c7ec36bb-bc6f-42de-9974-a50ac13e9410", "f65e93ec-4db6-44fa-bff1-8ae89aa8243f", "9f448171-9588-4a54-88b3-5d870060ce86", "92ab5942-823d-43aa-8e7a-56844ab8946f", "f54b250d-bd15-483b-b191-a664291382c1", "ac4ac150-d3e6-4bd1-8a4a-7d63fade3e49", "1e787808-b3e0-417a-b333-80619d15432b", "30b2b576-4939-4903-be59-dbd1624a5eb6", "09566368-f91d-43a3-b683-30c844fb125a", "a401fe31-d51a-49d9-a062-c9d22088db56", "be1c686e-37a5-4a53-945b-68a6ead35134", "24837d82-0f3f-4482-9af0-31e5f675c30f", "ccb1a15e-c943-4042-ae46-550bdabfc96b", "b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "52c822f2-4a71-4ab2-a470-58074622846a", "7c1f998a-233d-4feb-6ea2-457702abd0d2", "f3817543-544a-4afa-ac7c-c1b48c1307c2", "0283bc9d-6998-493a-824a-d4c85f704111", "d62a972a-bc45-4582-9701-bed27a1a9e4d", "e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe", "2b705cb6-cb75-4c2a-907a-4bd45d18bc2c", "8dae76a2-32e7-40a2-bb70-9c6380b9b330", "3ecff825-34ea-4535-b935-627bf2c13d93", "809c6386-0039-42ff-a03e-e42733e229b8", "cb76a73f-549a-4170-b96a-f93ed7e09464" ], "package_ndc": [ "72611-740-01", "72611-740-10", "0143-9873-10", "0143-9873-25", "0143-9660-01", "0143-9660-10", "0409-2016-05", "0409-2016-10", "30698-464-30", "30698-464-31", "52817-250-10", "52817-250-00", "52817-251-10", "52817-252-10", "52817-252-00", "52817-253-10", "52817-254-10", "52817-254-00", "76282-794-01", "76282-794-10", "76282-795-01", "76282-795-10", "76282-796-01", "76282-796-10", "59651-758-01", "59651-760-01", "72266-122-01", "72266-122-10", "72266-122-25", "57237-100-01", "57237-100-99", "57237-101-01", "57237-101-99", "57237-102-01", "57237-102-99", "36000-033-10", "72888-004-01", "72888-004-05", "72888-004-00", "72888-101-01", "72888-101-05", "72888-005-01", "72888-005-05", "72888-005-00", "72888-023-01", "72888-023-05", "72888-006-01", "72888-006-05", "72888-006-00", "63323-660-01", "63323-660-05", "62332-112-30", "62332-112-31", "62332-112-91", "62332-113-30", "62332-113-31", "62332-113-91", "62332-114-30", "62332-114-31", "62332-114-91", "65219-665-01", "65219-665-05", "30698-460-03", "30698-460-01", "30698-460-10", "52817-362-10", "52817-362-00", "52817-359-10", "52817-359-50", "52817-361-10", "52817-361-00", "52817-360-10", "52817-360-00", "52817-358-10", "52817-358-50", "0409-1778-15", "0409-1778-05", "25021-303-05", "30698-458-01", "30698-459-01", "72888-197-30", "72888-197-03", "72888-197-00", "68083-131-01", "65862-062-01", "65862-062-99", "65862-063-60", "65862-063-01", "65862-063-99", "65862-064-60", "65862-064-01", "65862-064-99", "72572-420-01", "72572-420-10", "72888-208-01", "72888-208-05", "72888-208-00", "72888-208-02", "72888-209-01", "72888-209-05", "72888-210-01", "72888-210-05", "72888-210-00", "72888-210-02", "72888-211-01", "72888-211-05", "72888-212-01", "72888-212-05", "72888-212-00", "0378-0018-01", "0378-0018-05", "0378-4593-01", "0378-0032-01", "0378-0032-10", "0378-4594-01", "0378-0047-01", "0378-0047-10", "46708-290-30", "46708-290-31", "46708-290-91", "46708-290-10", "46708-290-71", "46708-291-30", "46708-291-31", "46708-291-91", "46708-291-10", "46708-292-30", "46708-292-31", "46708-292-91", "46708-292-10" ], "unii": [ "W5S57Y3A5L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PERCOCET", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, THREE TIMES A DAY AS NEEDED", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\OXYCODONE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA040330" ], "brand_name": [ "PERCOCET" ], "generic_name": [ "OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN" ], "manufacturer_name": [ "Endo USA, Inc." ], "product_ndc": [ "63481-623", "63481-627", "63481-628", "63481-629" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OXYCODONE HYDROCHLORIDE", "ACETAMINOPHEN" ], "rxcui": [ "1049214", "1049221", "1049225", "1049625", "1049635", "1049637", "1049640", "1049642" ], "spl_id": [ "1e9711e4-67a9-4dc2-840b-477ae1ce7ad3" ], "spl_set_id": [ "4dd36cf5-8f73-404a-8b1d-3bd53bd90c25" ], "package_ndc": [ "63481-627-70", "63481-623-70", "63481-623-85", "63481-628-70", "63481-629-70" ], "unii": [ "362O9ITL9D", "C1ENJ2TE6C" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugdosagetext": "UNK", "drugindication": "NEUROPATHY PERIPHERAL", "activesubstance": { "activesubstancename": "PREGABALIN" }, "openfda": { "application_number": [ "NDA021446", "NDA022488" ], "brand_name": [ "LYRICA" ], "generic_name": [ "PREGABALIN" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc", "Viatris Specialty LLC" ], "product_ndc": [ "0071-1018", "0071-1012", "0071-1013", "0071-1014", "0071-1015", "0071-1016", "0071-1017", "0071-1019", "0071-1020", "58151-236", "58151-237", "58151-238", "58151-239", "58151-240", "58151-241", "58151-243", "58151-242", "58151-244" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREGABALIN" ], "rxcui": [ "483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127", "607018", "607020", "607022", "607024", "607026", "607028", "607033", "607038", "898715", "898718" ], "spl_id": [ "e7c79058-03ba-4e7f-9a31-9ec5ce245161", "1c2af07d-faf4-4fc7-b724-c5166746956d" ], "spl_set_id": [ "60185c88-ecfd-46f9-adb9-b97c6b00a553", "d4734e7d-5079-455e-8ff5-8f4539c998a9" ], "package_ndc": [ "0071-1012-68", "0071-1013-41", "0071-1013-68", "0071-1014-41", "0071-1014-68", "0071-1015-41", "0071-1015-68", "0071-1016-41", "0071-1016-68", "0071-1017-68", "0071-1019-68", "0071-1018-68", "0071-1020-01", "58151-236-77", "58151-237-32", "58151-237-88", "58151-237-77", "58151-238-32", "58151-238-88", "58151-238-77", "58151-239-32", "58151-239-88", "58151-239-77", "58151-240-32", "58151-240-88", "58151-240-77", "58151-241-77", "58151-243-77", "58151-242-77", "58151-244-35" ], "unii": [ "55JG375S6M" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BABY ASPIRIN", "drugstructuredosagenumb": "162", "drugstructuredosageunit": "003", "drugdosagetext": "162 MG, DAILY", "activesubstance": { "activesubstancename": "ASPIRIN" } }, { "drugcharacterization": "2", "medicinalproduct": "BUMETANIDE.", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 MG (HALF OF 2MG TABLET), 1X/DAY", "drugdosageform": "TABLET", "drugindication": "SWELLING", "activesubstance": { "activesubstancename": "BUMETANIDE" }, "openfda": { "application_number": [ "ANDA213942", "ANDA218746", "ANDA217153", "ANDA074441", "ANDA074700", "NDA219500", "NDA018225", "ANDA212019", "ANDA074225", "ANDA215364", "ANDA216434", "ANDA209916", "ANDA215362", "ANDA219116", "ANDA212931", "ANDA079196", "ANDA209724", "ANDA202900", "ANDA213458", "ANDA219291", "ANDA220427" ], "brand_name": [ "BUMETANIDE", "ENBUMYST", "BUMEX" ], "generic_name": [ "BUMETANIDE" ], "manufacturer_name": [ "Advagen Pharma Limited", "Camber Pharmaceuticals, Inc.", "Lupin Pharmaceuticals, Inc.", "Civica, Inc.", "Sandoz Inc", "Corstasis USA LLC", "Validus Pharmaceuticals LLC", "Rising Pharma Holdings, Inc", "NorthStar Rx, LLC", "Novadoz Pharmaceuticals LLC", "GLENMARK PHARMACEUTICALS INC., USA", "Upsher-Smith Laboratories, LLC", "Sagent Pharmaceuticals", "Qilu Pharmaceutical Co., Ltd.", "Exelan Pharmaceuticals, Inc.", "Amneal Pharmaceuticals NY LLC", "Zydus Pharmaceuticals (USA) Inc.", "Hikma Pharmaceuticals USA Inc.", "Sun Pharmaceutical Industries, Inc.", "First Nation Group, LLC", "Fresenius Kabi USA, LLC", "Anthea Pharma Private Limited", "Mullan Pharmaceutical Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Edenbridge Pharmaceuticals LLC.", "Solco Healthcare LLC", "Zydus Lifesciences Limited", "Gland Pharma Limited", "Lifestar Pharma LLC" ], "product_ndc": [ "72888-019", "72888-020", "72888-021", "31722-368", "31722-369", "70748-323", "72572-210", "72572-211", "0781-8099", "0781-8113", "0781-8160", "84388-005", "30698-630", "30698-631", "30698-632", "16571-677", "16571-679", "16571-678", "72603-297", "72603-298", "72603-299", "72205-101", "72205-102", "68462-469", "68462-470", "0832-0540", "0832-0541", "0832-0542", "72205-056", "72205-057", "72205-058", "25021-321", "67184-0593", "67184-0594", "76282-797", "76282-798", "76282-799", "72572-040", "72572-041", "69238-1489", "69238-1490", "69238-1491", "68382-525", "68382-526", "68382-527", "0641-6007", "0641-6008", "51672-4223", "51672-4224", "51672-4225", "81469-221", "81469-222", "81469-223", "65219-570", "65219-572", "0641-6284", "0641-6161", "0641-6162", "0641-6285", "83854-007", "83854-035", "83301-0080", "83301-0081", "23155-900", "23155-901", "23155-902", "42799-119", "42799-120", "42799-121", "43547-896", "43547-897", "43547-898", "70771-1024", "70771-1025", "70771-1026", "0185-0128", "0185-0129", "0185-0130", "68083-496", "68083-497", "70756-079", "70756-080", "70756-081" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "NASAL" ], "substance_name": [ "BUMETANIDE" ], "rxcui": [ "197417", "197418", "197419", "282486", "1727569", "2724437", "2724443", "205488", "205489", "205490" ], "spl_id": [ "47c8ef6a-8934-2514-e063-6294a90abae6", "32ba5fc2-0f9e-ee77-e063-6294a90af010", "39d376d9-2fab-40d3-8592-668c5083a0c9", "b178f54e-11e4-48a8-a6eb-845bbd89de1f", "8914d8bf-61b7-4cd2-a8ef-7e1c5df37828", "f23216fe-f3a4-4550-8b47-eaaef86d9356", "3e4799b2-7621-c0b4-e063-6394a90a47b7", "ad19edfb-a229-4767-890a-3bf6558ec191", "3aa9066b-354b-4f6b-87b9-2752a3a51f6b", "387edfd4-be85-41cd-8a6d-14e6a022b5a9", "f211e18e-2cd7-4316-8edc-089ed734ccb8", "d53166d9-64ca-4b76-81a7-b70a60c53b12", "cddd33fb-25b0-49ca-ab32-7c79a9b3a384", "88a191ea-bf0d-4c27-a33c-91a126ff1aba", "b392cf53-2b1f-46b5-86dc-c0df49f16730", "04a4ac27-f6b7-4a88-899b-93a5a21ddb6e", "fee7772b-da97-4671-a532-553d74a49d36", "d1961e90-3fcc-4b72-b207-6c9de6d66557", "58b3bb3b-6096-42fd-aebc-c856c3050071", "99d2fc38-7e1e-4209-aa57-089794eda8a6", "4db68936-9d9c-1821-e063-6394a90a7f1b", "25bc351d-4705-4d81-9d44-ac191ec15a34", "aaff61c4-203b-4905-9138-0f98959ad013", "cbf46236-4090-445f-ad19-fd9d767deecc", "55870799-16b8-35f0-e063-6394a90a6992", "4c241a3e-649b-4414-e063-6294a90a3a32", "ee0c44ac-10ca-4d9b-98f0-1342fc97dd39", "462dc93e-f284-3a48-e063-6394a90a7ce1", "4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6", "58cd32ca-26d5-4d9f-9c08-38c80720d7b4", "c6f31ac9-10d1-4d92-882e-836de10e1ce6", "d9e3877d-de1a-4047-9866-413958c4cca0", "f131948c-e75a-4379-b9ec-875fea59a5fe" ], "spl_set_id": [ "94078edd-b9c0-449e-baaf-a9afceccb407", "084b34ad-36ba-43bd-a43a-1f4b4da26d8f", "2c71a17e-ed76-4545-b23e-9f4997b13c2f", "4a9229c8-89ba-423e-8e36-f56bc329ed38", "8914d8bf-61b7-4cd2-a8ef-7e1c5df37828", "d6f752c5-d2bd-4f77-9611-ca2110066d1f", "32dfbea3-eb2b-4070-8605-57ce3e6d5a2f", "627c9732-eed1-4435-8d79-2e19ab974fd9", "6b92460e-48ba-44bb-9b61-5e65e5fd82cd", "387edfd4-be85-41cd-8a6d-14e6a022b5a9", "680563fe-5d3a-49bc-86a5-740bda2acebe", "ff5dc8c6-b2f2-41d3-8e56-a953aa721b59", "cddd33fb-25b0-49ca-ab32-7c79a9b3a384", "c38a404d-a919-4a2c-9fbb-d0655dee9516", "ef5fe12a-f8ee-4ba7-932b-51bbaccf6575", "06745425-e7e7-4413-b9ff-22b121f0ea9a", "308c690f-c2bd-4c32-8728-42ec95425f77", "9188ab17-8539-48a5-905f-ad35ab5a0b93", "525138cd-832a-41d0-84b0-83921b12bd2a", "681b5e9d-e2c7-4f29-aaad-e06d4a528c11", "5c753aae-77b7-4add-8453-385a8f62d7db", "79b77945-74a7-4cb5-8aa0-33a7babdf6d9", "a007f3aa-3977-4be3-a9a2-db3d458bca58", "b5a68154-8003-4b80-81e2-e926524fb72c", "9058fc52-f3f6-4d7f-b2a0-b1e2c714b133", "b7cd724b-817b-4b45-8133-1ebf505867e7", "d4688d53-9baf-4cf0-b37f-47779bce7815", "32c4372e-54ea-4fc8-b9f8-827fa4c8edd3", "4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6", "82eb62ca-c32b-4ff8-9f71-43219b240480", "05cb961d-ac33-4bcf-b04e-411e496c43c1", "4d1ed6b2-c410-4f52-9b8a-aa256c37089e", "51a344b6-acf9-4ac4-b743-1e63e3df7958" ], "package_ndc": [ "72888-019-01", "72888-020-01", "72888-021-01", "31722-368-31", "31722-368-32", "31722-369-10", "31722-369-32", "70748-323-10", "70748-323-11", "72572-210-01", "72572-210-10", "72572-211-01", "72572-211-10", "0781-8099-05", "0781-8099-01", "0781-8113-05", "0781-8113-01", "0781-8160-05", "0781-8160-01", "84388-005-06", "84388-005-12", "30698-630-01", "30698-631-01", "30698-631-05", "30698-632-01", "30698-632-05", "16571-679-01", "16571-678-01", "16571-678-10", "16571-677-01", "16571-677-10", "72603-297-01", "72603-298-01", "72603-298-02", "72603-299-01", "72603-299-02", "72205-101-01", "72205-101-07", "72205-102-01", "72205-102-07", "68462-469-40", "68462-469-54", "68462-470-40", "68462-470-54", "0832-0540-11", "0832-0541-11", "0832-0541-10", "0832-0542-11", "0832-0542-10", "72205-056-91", "72205-057-91", "72205-057-05", "72205-058-91", "72205-058-05", "25021-321-04", "25021-321-10", "67184-0594-1", "67184-0594-2", "67184-0593-1", "67184-0593-2", "76282-797-01", "76282-798-01", "76282-798-05", "76282-799-01", "76282-799-05", "72572-041-01", "72572-041-10", "72572-040-01", "72572-040-10", "69238-1489-1", "69238-1489-5", "69238-1490-1", "69238-1490-5", "69238-1491-1", "69238-1491-5", "68382-525-06", "68382-525-16", "68382-525-01", "68382-525-05", "68382-525-10", "68382-526-06", "68382-526-16", "68382-526-01", "68382-526-05", "68382-526-10", "68382-527-06", "68382-527-16", "68382-527-01", "68382-527-05", "68382-527-10", "0641-6007-01", "0641-6007-10", "0641-6008-01", "0641-6008-10", "51672-4223-1", "51672-4224-1", "51672-4225-1", "81469-221-01", "81469-222-01", "81469-222-05", "81469-223-01", "81469-223-05", "65219-570-01", "65219-570-04", "65219-572-01", "65219-572-10", "0641-6161-01", "0641-6161-10", "0641-6162-01", "0641-6162-10", "0641-6284-01", "0641-6284-10", "0641-6285-01", "0641-6285-10", "83854-007-01", "83854-007-10", "83854-035-01", "83854-035-10", "83301-0080-1", "83301-0080-2", "83301-0081-1", "83301-0081-2", "23155-900-01", "23155-900-05", "23155-900-10", "23155-901-01", "23155-901-05", "23155-901-10", "23155-902-01", "23155-902-05", "23155-902-10", "42799-119-01", "42799-120-01", "42799-120-02", "42799-121-01", "42799-121-02", "43547-896-10", "43547-897-10", "43547-897-50", "43547-898-10", "43547-898-50", "70771-1024-3", "70771-1024-9", "70771-1024-1", "70771-1024-5", "70771-1024-0", "70771-1025-3", "70771-1025-9", "70771-1025-1", "70771-1025-5", "70771-1025-0", "70771-1026-3", "70771-1026-9", "70771-1026-1", "70771-1026-5", "70771-1026-0", "0185-0128-05", "0185-0128-01", "0185-0129-05", "0185-0129-01", "0185-0130-05", "0185-0130-01", "68083-496-01", "68083-496-10", "68083-497-01", "68083-497-10", "70756-079-11", "70756-080-11", "70756-080-51", "70756-081-11", "70756-081-51" ], "nui": [ "N0000175366", "N0000175590" ], "pharm_class_pe": [ "Increased Diuresis at Loop of Henle [PE]" ], "pharm_class_epc": [ "Loop Diuretic [EPC]" ], "unii": [ "0Y2S3XUQ5H" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFORMIN", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1000 MG, 2X/DAY", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA200690", "ANDA209674", "ANDA209313" ], "brand_name": [ "METFORMIN HYDROCHLORIDE", "METFORMIN" ], "generic_name": [ "METFORMIN", "METFORMIN ER 500 MG", "METFORMIN ER 750 MG" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Ingenus Pharmaceuticals, LLC", "Granules Pharmaceuticals Inc." ], "product_ndc": [ "0378-6001", "0378-6002", "50742-633", "50742-634", "70010-491", "70010-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "1807894", "1807917", "860975", "860981" ], "spl_id": [ "2a0bac1b-3575-4b62-a74b-07f54ba064af", "3a97a225-ff03-4d81-a2fe-7f66611cc4c1", "537f5fd2-89a1-d029-e063-6394a90a9d0e" ], "spl_set_id": [ "7e41818c-60e9-4bcf-9586-7bb8d33d5e89", "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "GLIMEPIRIDE.", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 MG (HALF OF 4MG TABLET), 2X/DAY", "drugdosageform": "TABLET", "activesubstance": { "activesubstancename": "GLIMEPIRIDE" }, "openfda": { "application_number": [ "ANDA077911", "ANDA077091", "ANDA091220", "ANDA202112", "ANDA077370", "ANDA202759", "ANDA078181" ], "brand_name": [ "GLIMEPIRIDE", "GLIMEPIRIDE 3 MG" ], "generic_name": [ "GLIMEPIRIDE" ], "manufacturer_name": [ "Carlsbad Technology, Inc.", "Dr. Reddy's Laboratories Limited", "Micro Labs Limited", "Florida Pharmaceutical Products, LLC", "Solco Healthcare U.S., LLC", "Rising Pharma Holdings, Inc.", "BluePoint Laboratories", "Accord Healthcare Inc", "Aurobindo Pharma Limited", "Lifsa Drugs LLC" ], "product_ndc": [ "61442-115", "61442-116", "61442-117", "55111-320", "55111-321", "55111-322", "42571-100", "42571-101", "42571-102", "42571-103", "42571-104", "42571-105", "71921-214", "71921-215", "71921-216", "43547-394", "43547-395", "43547-396", "16571-773", "16571-774", "16571-775", "68001-584", "68001-585", "68001-586", "16729-001", "16729-002", "16729-003", "65862-579", "65862-580", "65862-581", "72336-641" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "GLIMEPIRIDE" ], "rxcui": [ "199245", "199246", "199247", "153842", "1361493", "1361495" ], "spl_id": [ "2386d706-9dab-4ae0-e063-6394a90a8a06", "e3d50334-9896-b2f9-a481-8383eb84b16a", "34e9a6b6-450b-7d20-e063-6294a90ac831", "52fcdeaf-e64f-48bd-b90d-e7502b104ae1", "95a5568d-751c-4497-b70c-5cc358bbb2af", "f06a97e3-4349-4df3-87de-4479c1ed69bc", "39526e66-ce21-103e-e063-6294a90a5967", "415deb6c-47dc-ed2a-e063-6394a90a66fa", "cb22d2cd-964e-4ce6-8647-2abe0426b570", "8f56950f-d08d-44d4-9c7c-9830e9bfadb8" ], "spl_set_id": [ "72d88c6d-2f0a-4bf8-aa7f-1e1811794187", "07ad4366-4b21-f633-49f3-c2b35f88168d", "60e9397e-83b9-489e-9683-6f87e458bbaa", "8ff0de99-272e-4e68-9caf-69f3f146ac29", "86acdd9e-8637-43e4-8bf7-b3a123b871b8", "48ada723-8144-497d-afd6-a8c52a1dd3ff", "a01b0466-13f5-4c47-ae55-c5f1527d9414", "9b74fbac-9e04-4927-9981-1e3dace89c6d", "28eefc95-d92e-4555-b6c5-2933860b0610", "51157849-7990-4a8b-ae50-eda1baf93cfa" ], "package_ndc": [ "61442-115-01", "61442-115-05", "61442-115-10", "61442-116-01", "61442-116-05", "61442-116-10", "61442-117-01", "61442-117-05", "61442-117-10", "55111-320-30", "55111-320-01", "55111-320-05", "55111-320-79", "55111-320-78", "55111-321-30", "55111-321-01", "55111-321-05", "55111-321-79", "55111-321-78", "55111-322-30", "55111-322-01", "55111-322-05", "55111-322-79", "55111-322-78", "42571-100-01", "42571-100-05", "42571-101-01", "42571-101-05", "42571-102-01", "42571-102-05", "42571-103-01", "42571-103-05", "42571-104-01", "42571-104-05", "42571-105-01", "42571-105-05", "71921-214-01", "71921-214-50", "71921-215-01", "71921-215-50", "71921-216-01", "71921-216-50", "43547-394-10", "43547-394-50", "43547-395-10", "43547-395-50", "43547-396-10", "43547-396-50", "16571-773-01", "16571-773-50", "16571-774-01", "16571-774-50", "16571-775-01", "16571-775-50", "68001-584-00", "68001-584-03", "68001-585-00", "68001-585-03", "68001-586-00", "68001-586-03", "16729-001-01", "16729-001-16", "16729-001-17", "16729-002-01", "16729-002-16", "16729-002-17", "16729-003-01", "16729-003-16", "16729-003-17", "65862-579-01", "65862-579-05", "65862-579-99", "65862-580-01", "65862-580-05", "65862-580-99", "65862-581-01", "65862-581-25", "65862-581-05", "65862-581-99", "72336-641-01" ], "nui": [ "N0000175608", "M0020795" ], "pharm_class_epc": [ "Sulfonylurea [EPC]" ], "pharm_class_cs": [ "Sulfonylurea Compounds [CS]" ], "unii": [ "6KY687524K" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CLOPIDOGREL SULFATE", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "75 MG, 1X/DAY", "activesubstance": { "activesubstancename": "CLOPIDOGREL BISULFATE" } }, { "drugcharacterization": "1", "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "4", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "75 MG, 4X/DAY", "drugindication": "DIABETIC NEUROPATHY", "drugenddateformat": "102", "drugenddate": "20140710", "activesubstance": { "activesubstancename": "PREGABALIN" }, "openfda": { "application_number": [ "NDA021446", "NDA022488" ], "brand_name": [ "LYRICA" ], "generic_name": [ "PREGABALIN" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc", "Viatris Specialty LLC" ], "product_ndc": [ "0071-1018", "0071-1012", "0071-1013", "0071-1014", "0071-1015", "0071-1016", "0071-1017", "0071-1019", "0071-1020", "58151-236", "58151-237", "58151-238", "58151-239", "58151-240", "58151-241", "58151-243", "58151-242", "58151-244" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREGABALIN" ], "rxcui": [ "483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127", "607018", "607020", "607022", "607024", "607026", "607028", "607033", "607038", "898715", "898718" ], "spl_id": [ "e7c79058-03ba-4e7f-9a31-9ec5ce245161", "1c2af07d-faf4-4fc7-b724-c5166746956d" ], "spl_set_id": [ "60185c88-ecfd-46f9-adb9-b97c6b00a553", "d4734e7d-5079-455e-8ff5-8f4539c998a9" ], "package_ndc": [ "0071-1012-68", "0071-1013-41", "0071-1013-68", "0071-1014-41", "0071-1014-68", "0071-1015-41", "0071-1015-68", "0071-1016-41", "0071-1016-68", "0071-1017-68", "0071-1019-68", "0071-1018-68", "0071-1020-01", "58151-236-77", "58151-237-32", "58151-237-88", "58151-237-77", "58151-238-32", "58151-238-88", "58151-238-77", "58151-239-32", "58151-239-88", "58151-239-77", "58151-240-32", "58151-240-88", "58151-240-77", "58151-241-77", "58151-243-77", "58151-242-77", "58151-244-35" ], "unii": [ "55JG375S6M" ] } }, { "drugcharacterization": "2", "medicinalproduct": "JARDIANCE", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, 1X/DAY", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LISINOPRIL.", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 1X/DAY", "drugindication": "DIABETIC COMPLICATION", "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", "0591-0409", "0591-0405", "0591-0406", "0591-0407", "0591-0408", "0591-0885", "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", "99502ee9-cea6-473a-91c1-e4b4ded719e2", "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": "EXALGO", "drugstructuredosagenumb": "12", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "12 MG, 1X/DAY", "activesubstance": { "activesubstancename": "HYDROMORPHONE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "TRAZODONE", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "50 MG, 1X/DAY AT BEDTIME", "drugindication": "SLEEP DISORDER", "activesubstance": { "activesubstancename": "TRAZODONE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE.", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 1X/DAY", "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "NDA209400", "ANDA206582", "ANDA075576", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", "ANDA076048", "ANDA211732", "ANDA204012", "ANDA218829", "ANDA091672", "ANDA213201", "ANDA078490", "ANDA212977", "ANDA203270" ], "brand_name": [ "GOOD NEIGHBOR PHARMACY OMEPRAZOLE", "OMEPRAZOLE/SODIUM BICARBONATE", "KIRKLAND SIGNATURE OMEPRAZOLE", "OMEPRAZOLE", "FOSTER AND THRIVE OMEPRAZOLE", "ACID REDUCER", "BERKLEY AND JENSEN OMEPRAZOLE", "GOOD NOW OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE", "BASIC CARE OMEPRAZOLE", "UP AND UP OMEPRAZOLE", "EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER", "DG HEALTH OMEPRAZOLE", "TOPCARE OMEPRAZOLE", "CAREONE OMEPRAZOLE", "EQUALINE OMEPRAZOLE", "LEADER OMEPRAZOLE", "EQUATE OMEPRAZOLE", "DG HEALTH OMPERAZOLE", "OMEPRAZOLE DELAYED-RELEASE", "SIGNATURE CARE OMEPRAZOLE", "MEMBERS MARK OMEPRAZOLE", "AMAZON BASIC CARE OMEPRAZOLE", "RUGBY OMEPRAZOLE", "TOPCARE OMEPRAZOLE DELAYED RELEASE", "24 HR OMEPRAZOLE", "CARE ONE OMEPRAZOLE", "EXCHANGE SELECT OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE DELAYED RELEASE" ], "generic_name": [ "OMEPRAZOLE", "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Amerisource Bergen", "Strides Pharma Science Limited", "Costco Wholesale Company", "INNOVUS PHARMACEUTICALS, 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", "BJWC", "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", "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", "AMERISOURCE BERGEN", "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. (see also Equate)", "Camber Pharmaceuticals, Inc.", "H-E-B", "KROGER COMPANY", "Living Better Brands LLC", "Safeway", "Publix Super Markets Inc", "Sam's West Inc", "Camber Consumer Care Inc", "Glenmark Pharmaceuticals Inc., USA", "Family Dollar (FAMILY WELLNESS)", "Allegiant Health", "Dr. Reddy's Laboratories Limited", "Kroger Company", "NorthStar Rx LLC", "BI-MART", "Family Dollar Stores, LLC", "Chain Drug Marketing Association INC", "AMERISOURCEBERGEN DRUG CORPORATION", "CVS Pharamacy, Inc", "Bi-Mart", "Dr. Reddys Laboratories Inc", "Aurobindo Pharma Limited", "UP & UP", "Winco Foods, LLC.", "Xiromed, LLC", "WALMART INC.", "7-Eleven", "Army & Air Force Exchange Service", "Best Choice", "Rising Pharma Holdings, Inc.", "Walgreens", "Wal-Mart Stores, Inc." ], "product_ndc": [ "46122-281", "64380-182", "64380-183", "63981-915", "57483-740", "51660-029", "70677-1275", "70677-1098", "57896-659", "62175-114", "62175-118", "62175-136", "0363-1008", "0781-2785", "0781-2790", "70000-0521", "62135-559", "62135-530", "68391-103", "69842-941", "72036-981", "63548-8040", "69618-054", "53943-016", "82501-0915", "0113-0915", "67091-464", "58602-850", "57483-840", "72288-047", "79481-0061", "41250-915", "68391-915", "59779-503", "37808-401", "59640-047", "82009-022", "11673-346", "55315-996", "49035-915", "30142-992", "42507-164", "79481-0281", "55910-915", "36800-915", "55910-712", "65841-759", "65841-760", "65841-761", "80136-852", "59726-744", "51316-271", "63548-2970", "72476-473", "0363-1819", "58602-826", "41163-915", "72559-014", "0113-1723", "41520-939", "41163-634", "51407-664", "51407-814", "0363-9980", "45802-888", "69842-791", "46122-686", "37808-915", "63548-4080", "68001-441", "70000-0723", "55681-306", "62756-377", "68382-411", "68382-412", "68382-500", "49035-119", "79903-305", "0781-2234", "0363-6101", "55910-713", "57483-120", "60505-0065", "60505-0145", "60505-3952", "60505-0146", "41250-349", "70677-0148", "0363-0915", "11822-0061", "83324-011", "11822-0453", "0536-1322", "63941-997", "59726-740", "0113-6010", "79903-377", "0113-0520", "31722-527", "31722-528", "37808-569", "0363-0007", "30142-077", "21130-991", "59726-298", "51316-843", "21130-128", "56062-401", "70677-1104", "68196-700", "69230-318", "68462-395", "68462-396", "68462-397", "56062-915", "55319-219", "68196-915", "58602-837", "59779-580", "69168-476", "79481-3023", "55111-643", "55111-644", "55111-645", "30142-474", "72288-409", "0536-1448", "36800-121", "16714-714", "16714-715", "37835-001", "42507-414", "11673-018", "30142-394", "30142-593", "36800-601", "0781-2859", "0781-2868", "55319-037", "83324-141", "82009-023", "82009-183", "21130-783", "0363-6089", "46122-029", "46122-739", "41250-401", "63548-7370", "55111-157", "55111-158", "55111-159", "0363-4099", "11822-1190", "21130-528", "51407-641", "51407-943", "51407-813", "30142-557", "51316-061", "79481-0075", "37835-189", "43598-286", "46122-616", "72288-401", "72288-123", "59651-001", "59651-002", "59651-003", "11673-948", "41520-915", "67091-316", "70700-149", "70700-150", "70700-151", "55910-215", "16714-123", "16714-630", "16714-634", "72288-915", "72288-606", "21130-401", "79903-113", "10202-722", "69842-661", "11673-212", "42507-915", "43598-841", "55301-915", "63941-006", "57237-160", "57237-161", "57237-162", "0363-9510", "11673-915", "37808-354", "76162-470", "49035-983", "0113-1803", "21130-137", "41520-802", "70000-0381", "58602-729" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OMEPRAZOLE", "SODIUM BICARBONATE", "OMEPRAZOLE MAGNESIUM" ], "rxcui": [ "402014", "753557", "753562", "198051", "199119", "200329", "2003656" ], "spl_id": [ "b734d645-be14-4398-b7e2-9017c771fff1", "2ac68a93-2f3b-46aa-a874-c109ad1bfefe", "633c827b-bb87-4c7f-9865-633006a60e21", "ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "e9ea61cb-d280-42b0-8819-34117270c618", "07de4a08-07e5-444b-8d1b-7f259b32936e", "252eeb77-6319-49df-9259-fcf2f917b2b5", "df05ccee-e8d0-43b2-a266-86afc1ce741c", "e786b865-dc62-4018-9cb1-7056b7ca2cde", "f3c6b5e7-49d3-4c89-907f-782953c31b90", "24a57c2e-eda8-4c3f-9c81-a28a5b9a9229", "a54de89f-8710-4fc7-97c3-8607e5974263", "2df74daf-da0f-36e2-e063-6294a90abc9d", "46879e67-0bb9-93a7-e063-6294a90af37d", "c7b50625-4920-4bb2-8eff-943670438248", "94a59c53-72bd-4d37-9ea9-c73f51ea1031", "ca9797c6-5708-4d45-bd1a-c670077e1a0b", "4e880f49-93d0-436b-a072-c3286d358e45", "ba632dd1-c85a-49c0-88a6-6d10ddbff1af", "0029ee94-3c34-42fb-982f-9baefdfe0b3b", "fa4938ea-ffb5-466e-8fce-4fdfdc97989e", "1d135e1c-1e90-4e42-a2c7-2ef3b3fc6545", "5c220251-3504-4c65-a385-85920515c499", "492b45bf-5734-4a64-8907-feaebadbb41a", "3fc301fe-e89b-488b-8437-c48b59cec420", "e00843ad-85f1-458c-9f2c-c1c4b41947a7", "77a11f0a-d2ce-40b7-8c19-011d6665d18b", "88bf3550-4633-47fe-88ec-e9ca94f7f752", "74157f10-5953-44de-abf5-b6793f13e70d", "2d9d60cd-6c79-4da7-9c48-ac1b73df9832", "9cb203e7-86d0-4757-9a32-afd2038898a3", "5d5df90d-3535-4337-99d8-e7e0309b433e", "17380ad5-9506-8e44-aa84-b6ce52ac7b9b", "dc644613-1131-499d-9c16-7ee241a10c26", "5df31fd8-49c4-4a00-aadc-3f02860ab01f", "03d865a0-ac92-49d5-82e2-2276292add17", "759b705a-526e-47e2-97f9-a78ab21a2c5d", "c1ec28a1-d0e5-4878-8295-eb06ff5e1fd6", "edbe9a75-73ef-4b53-8f08-10e775091e23", "4900f1e8-5133-4ef9-a871-4d88507d56eb", "e1557259-5889-4677-981e-ebd3970162c8", "72620a9f-63f1-421d-825a-ac73e891cd08", "691b64ae-e6ff-4a10-9973-886901529db0", "29498c01-1121-44bf-9a93-d5c5438bb83c", "141dd771-bc04-40b1-a80e-95ce0a471d6c", "6fe0d098-2eb4-49b6-881f-fbe7e102bfcb", "2bd05b96-ec80-440b-9e49-53c375ce9f8c", "965c30c2-5455-4f16-8fbf-2c57329806d5", "d56182bb-d424-4890-93c6-bca29194af8c", "d4d5397d-41ee-4c3c-bf0f-a923b1731d0b", "9cf01d8d-1fe8-4350-a23b-065f4d126547", "4d29deee-4362-9457-e063-6394a90a87eb", "c0f585e4-bc50-4364-9864-63ef2c3c9467", "7a2142d9-ea48-4cd8-bb1a-aed470b43852", "d806739f-7f7b-42ae-af48-d1b0b22d3eef", "4f745e3f-7028-51ec-e063-6294a90af7af", "8add376a-81a3-41e0-ba8d-037f7f56165a", "390ed372-f284-46b1-92bd-c2432fe6920b", "21aa099b-aabb-40ee-bbea-9db44c62e1e8", "47dce86f-d184-44cf-8ee3-18dad7f401b8", "0623c22d-32db-42d7-8a2b-d50e96baae5b", "6039daeb-5242-4b4e-80c9-45cb90249eba", "0486dc89-1bf1-8e37-e063-6394a90a9aa7", "01e166d4-7ac5-421f-87d2-7b647631bf8d", "c9a11bc6-0680-4030-871e-599417fccf57", "676e2f39-d83e-485a-9366-ed14c382e466", "d0074baa-52cb-4039-9bd8-966a36ff70da", "65ea67fd-2018-49ce-bccf-3d4ccf4f235b", "cd2683cb-42a1-cb9f-6dd4-a1464ddb3afd", "fe6aa833-89e6-4679-a7b8-6600e92c1bed", "ef7892f0-4389-4c7a-bc74-dabebce4b128", "d1d7bb64-1c13-4d36-b761-01ac075da14a", "72b23ff2-70a3-412c-9a9c-902927598e2f", "8619e520-d106-4778-e92a-09b919b55c70", "e3d7b200-cb51-46f2-aebf-b95ddac1b664", "b4a9538c-049e-45d3-8b28-581c68a36ed6", "364bb6a8-58c8-460d-92db-c25b9eed8d2b", "67c3cfe2-ab40-4c32-b386-ad3c740e3f6f", "164b1d0f-ad03-40dd-e063-6394a90a6771", "b518a17f-c0c9-4f15-884f-e2b193115a96", "6616864c-9739-4e69-86a1-29c07441f9ba", "9c033207-ae1c-4212-aeef-3bb5bfef6fca", "e9703fb1-76b2-42e6-9ceb-51aaa62bca31", "b840439b-540b-465a-8faa-f7b1024c628e", "1fabf3d4-e22f-474e-8812-679544cc48aa", "5e2cb7f9-93ec-4919-9648-0ecb1c5fe086", "2b439e93-9a24-e64a-e063-6394a90a634f", "50962214-2053-1974-e063-6394a90a0fc0", "8e923ce5-8ec6-464d-9772-55a9b1213cdf", "f5f26771-fb6e-4fc5-8ad9-92c64a9d7b81", "1a05a724-635a-49fa-a890-85363fd43a27", "1ef5cd55-c1c3-40a9-9486-91ad26c24a1c", "2480bbfc-d4fe-4d52-b9a6-48c9f4fe9698", "eb0dd73c-7d2d-424f-a939-dcdb18ee21f1", "8137007b-8ac1-4c7e-bc89-d9d9bb66a8ea", "4bb8b63d-4f46-4d58-a069-c88a969e960a", "7292128d-5bd2-4239-b53d-22ec365a835e", "ee873df8-2b35-9bc7-e053-2a95a90a0f83", "69b1e229-f845-4608-be48-f97e8d3e2273", "23f9d37a-deb7-4e56-90bc-13099e0d1e8f", "5ab86c77-4f33-46e4-84dc-57c96b8fc490", "ec7763a5-521c-486b-8215-2d66c97c3977", "0c2600f3-e9de-4e73-8ee1-9aeb94d228e4", "e5387742-f011-4d3c-b3ed-44e0251b053f", "37309c28-8650-401e-9a39-6b52112e0baf", "d9659b73-1336-4777-8ce9-926b851e1616", "8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d", "90aa0006-a47e-4058-bff3-5fb2d7bef8f1", "0e2645ca-76b7-4f38-9513-cba86dfa20a3", "bc786388-cb4d-4210-9124-39a4bcbb7d38", "f384bca8-e266-489a-8d87-3df17e7d0a56", "9ced381c-99a7-a9c4-211a-82326fb17900", "31dbc48a-ec90-e368-e063-6294a90a6c96", "c7e11072-2333-4846-a37b-2b2c3a59a6d0", "a8a64ea9-0d2c-45d5-a81d-da0d8ce60044", "46b01c78-c491-4087-a980-a43add76537d", "97fc5b6e-8e86-4774-933d-c85dfe71825d", "0edd49e4-cf9e-42db-8bbb-78ce370ac480", "b182f298-e28f-434b-b6f1-ecfac29d495e", "c1eee169-a04a-485d-9c17-2229cdca1fd1", "c8061435-ef48-b29f-b9bc-3fdda780ecc4", "8aee798c-2e69-76b9-85b5-3a4e0a0c7a94", "ba9d8915-89e0-4a90-a8e3-03784b496950", "cc051c20-36b7-4eb6-95e5-65734ef65458", "9517ab3c-69eb-4c6b-b65a-b3411b6373a9", "0c214fe9-7d95-39e0-0526-2d257f47695e", "9215653a-ae65-423a-9eb6-c94f21fe4413", "2cb02338-e348-4b60-aae0-e7806e03f5bf", "0dc50704-e0d5-1fcc-b0b5-6e5556db65e8", "4565e652-447a-484b-b8d2-adde9454111c", "e00e0544-dee7-4322-aa62-e1b912f2e6cf", "e018508f-372e-4b81-9979-15dbd798b271", "3ba5e1e5-159d-2492-e063-6294a90a6c8b", "ca200f16-7b7e-4b33-964b-e2ccfc62f0f4", "a3b8b93d-6725-4c5c-8b80-dcc27e408501", "9dee9797-6b74-498a-9237-53ac64642d27", "cd7c9c63-7126-43f0-bca2-f0d263415e36", "ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4", "99568183-6575-488b-a829-414bb8cf34a6", "02dbc562-2299-4c4d-a107-944a2b342d1a", "3d759662-06ea-46b7-b26e-33f376b7e262", "4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a", "ef059a98-451b-4590-93b4-937b855d6595", "5248b065-e6de-4bc6-af17-ee5e7ecdc45f", "cdedc06f-c813-421a-b613-0768f17d8633", "49528611-b139-6768-e43e-bc6f26715fa3", "fe39c1c0-3f79-418f-88c7-e4f40619b77e", "fe36a9a7-13d0-f4f1-1e31-b35cf651b79d", "617f2b9c-d13b-4128-af41-af5abd3e7bfe", "0cb73d40-2e1f-4197-a2bd-038b2295738f", "fd87b124-5abc-4db7-9125-350ac1699a1d", "a9fc2493-e10b-4d7a-9708-18ecdc757ef4", "d9c2719b-9650-41da-8ad4-085852934eeb", "20b6b69a-3bd9-42a4-a225-7efbf97a99eb", "1713a351-8a7a-405c-b37d-e01c2de0c246", "926d7c5a-14db-4560-ac64-898166bf2241", "bf20de45-af46-d037-efd5-6efe069d0569", "8adc4bc1-677f-4ad1-b301-bb5f25ce0205", "3a3a6029-3c1c-4c22-863d-1bf12733c39f", "aec12e35-60fb-416c-a2d0-a87cfdcb30a6", "6c1e8126-e1ab-4087-a25e-872bcace2a60", "cd15d39d-8e0a-4c39-806a-ff9951f33434", "51d6a6ce-e096-4152-876e-472f6b47e5bb", "255def35-0ba3-44c0-af0c-e5aa99806996", "b0339709-5175-4501-a96b-67ae8b88e153", "bffe358a-cc5a-4ff6-9a04-b0fbca4444e7", "fe806f67-4a8c-40ae-9750-d0c7a4a33aa6", "704e2091-bd15-4fd1-892e-425dffd01656", "867caf67-b128-4c09-9e35-352f8c04bcbe", "81d45120-49d4-4de8-8477-79312e2c1d56" ], "spl_set_id": [ "5ee3cb79-5c0c-456f-b5d5-d5a008bbd118", "cf6d293e-d70d-443e-8292-d693e93aab55", "48a44d0c-3502-430b-8b75-188a49d14da2", "ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "35a95bec-51b9-465b-aa93-ad26afb87be8", "51bcc19d-acfc-487b-870b-251c8953741f", "56380ccc-6fc2-4e1b-bd87-da24c9aa31cd", "8a77aea7-912e-43a3-bce3-f666b9b9c9bc", "92201fb1-4570-42db-8da3-3b8c0e291d32", "b9561780-e358-b610-e053-2a95a90af020", "e4562da8-9d94-4417-9f80-c1ffd4247259", "230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8", "4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e", "10f5502a-2e63-4f2a-a3ba-ddc5bd403051", "1729c60d-3475-45cd-b192-f88438403d1a", "3349ee88-e53b-4586-8d28-20ecf8fcb1a5", "c618964f-4b16-448e-851b-e6b2a816c660", "e67bf2c6-0618-48e0-aa08-705501d86431", "f6b13640-6c71-4c3d-8eb5-c36fca201aee", "ff2c8446-9d8b-4300-b157-884b48e98bb7", "0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f", "11dfbf6c-59bf-4a30-b627-f49ccd31c0d0", "2782b98b-50e4-4a4e-8626-d34ebfd71bfb", "287ceb12-e4d8-43c7-8cec-c4d23aa8fb12", "7535a309-1a67-4f50-911b-7cf570322931", "76b941f0-a02f-43e8-821e-09ccf675d944", "8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573", "925399c7-dcbc-4546-9111-2a98a11ba538", "f74752a8-a686-4c7d-91ad-8c87c4596a7a", "fb3b1c3b-d486-4fa6-9ebf-ee1812ed2512", "491e3710-9a15-4b07-ae22-923bd1152ecc", "501d80c0-68ee-4fd9-bc56-0b214dbf72b5", "665e9877-85ac-fdb6-54ac-1c47941ceab8", "7dc339da-e90b-452b-b25e-8d7f3aa8bc18", "7f00d0ed-4b7e-7011-e053-2a91aa0a2454", "9a0f2d8a-eaad-403b-90c3-0fd275abe4dc", "f55cedc7-e0bc-4d30-af52-bfa881f6adde", "fd22d4df-9679-4c2d-9bc4-3619288fb4cc", "0340ef94-d2b4-47af-a045-d0d031293984", "326bf21c-fad4-473e-9e7f-797319d4353a", "4d98665d-38db-4c08-8406-cc0e45f7ab7c", "6d19783d-2856-4a86-9f5c-6cc26b4ca33e", "2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2", "35ceccb5-dc3d-4ee1-bdac-35cb52c22f59", "883e428a-e157-4bbf-8657-e7a93dc99e8c", "8edfcc08-a14e-4579-bd44-045267de5b79", "d9c8a242-bdba-4f92-8629-692b47ebba21", "063cfad8-3ca6-4b72-a4c9-512b8047bae3", "064f048c-eddd-4370-9ee4-706f9f00c8d2", "3eb70031-6439-44cf-8056-3e2e1e4a7fa9", "b6c87a6a-253a-4455-9b7d-62f506da592e", "d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f", "db333c49-2c3e-4ade-a202-7d4499205fc4", "5b88717a-e90c-4e74-ae2a-29270e14a3cc", "78743f3b-257e-49df-98cd-6cc0e1b4e370", "f27b3518-d5c1-1229-e053-2a95a90ab56f", "537b9a46-ecc8-4537-9657-c9ff7821dd4b", "cb47354c-297b-4dc2-85af-242acc967b56", "01bde9ca-0114-426d-8188-c55aefaa0961", "47dce86f-d184-44cf-8ee3-18dad7f401b8", "5ceaec04-3ca3-4c7c-9184-51a42686a595", "6a1aeb95-5760-4363-816a-fa8305979c50", "a86d52a5-15e2-012d-e053-2a95a90ac912", "19beab17-ca25-4be3-bada-20a2e9aa26b5", "346141b5-b49d-489a-84eb-18df8b940460", "51c3ef34-b7c1-419e-a784-ae82540c7a22", "9c22ceb2-2c34-43c3-9a35-2589c9078741", "504b8282-d93f-454f-9f93-84cb8a9105d7", "5168ccd9-31b4-3a49-85b9-4f202cd99f6b", "5a09ce48-7139-4fc7-9b6e-439459c8e866", "87cee50d-4c1e-473d-9d70-b1622f84aee1", "99fdfeed-6828-4bf6-bb81-cd29a4ec610b", "a4e92bd2-8f75-4acc-9b75-df8332bd4cc4", "b83329ac-a65e-b3af-a3fb-c5a6c740e5e7", "d54e1097-bd56-4371-8e59-8ceab1a5e824", "dfa91081-3917-4dfc-9789-76800f57bb31", "30a893d2-198a-4184-81b4-02399324ff29", "b1ba65d1-8f68-4bae-bb9d-776bba348346", "da09aac6-8fce-448b-98ba-1fc9bce42075", "ee853401-b641-4dab-b708-29424c2d0b79", "33990795-e994-4307-a570-9e8e8b44c473", "7b2d41b6-3e36-4973-b5f6-adf9b828f40d", "911a08c4-ba73-4600-a5f2-7f26ba8c8604", "b840439b-540b-465a-8faa-f7b1024c628e", "d3c1ba08-680d-4e39-875c-1f1d42ae787c", "dcd93796-8904-415d-a379-c4ea590cf544", "0c6e00a2-31e8-4e84-928d-80e69a5fc634", "448ba584-6a6e-3d85-e063-6294a90a5579", "b7972f17-4a63-4d78-a181-01ea6d7d3963", "eb5d02a8-4112-2066-e053-2a95a90abba3", "1d500e2d-395b-437e-a95c-3922a71a0956", "44a92926-1941-4fe8-9b2a-31a45289456f", "6479415a-ffb0-4d20-ad00-f091c8aaaadb", "c76c4235-92d4-4384-8ddc-ceed0b928c48", "05fae639-ba68-4c05-8ca7-7c5cc2d50584", "836efc63-b633-497c-ab56-76bb495bd723", "907e9974-46b8-4dae-be92-518c076cb98f", "9c856d3a-e38f-4006-a43a-ec1a9fa0f057", "c6c22be1-659d-4e71-b292-701e27da201b", "e4a68b0a-a550-4416-8911-1defe014ad89", "f2195d73-1fd5-4de2-aa5c-18741d11f4fc", "0edfa800-fb14-44dd-9c31-de930b864ef9", "19097902-a5e6-423a-8569-31c569cd3cdb", "19b5b960-cc4d-42d0-8c8a-04a355a4db92", "3344c589-c4ac-4f2d-8d32-828db4e825a6", "47c41c68-cb20-40f0-9d85-ea8db3328478", "603d2d06-c5e8-4378-a422-8dca1a410af7", "da18d91c-5fe9-44d4-9d6f-602900af3f08", "10efef7c-bdf4-36cf-e063-6394a90a8c0f", "61952807-f38d-4e7a-8646-a8ec85d7fb37", "8ed57521-e69a-4563-9ce2-4f6d667f065d", "c5af5f4b-17be-7245-b281-f27c87831242", "fb089d15-daa4-477a-be83-ecd55c3283d4", "cf9919e6-a839-4bad-a007-80d5bf6f81db", "d664c45d-564a-4692-ae8f-8dd980ffcd87", "083841e8-482d-4e5b-90ab-1139b576d691", "236a9447-23ec-44c7-a241-20f9ddc83ab8", "436c5ea1-c5ee-481f-803d-439f65873b1c", "516170d4-4913-4577-a2d2-f5c52d1e79c6", "6d8daf78-1672-4bbf-a022-514bf0a5ac9a", "77d4f6c7-87ca-78bb-3310-2304a68f9f9b", "8090d4c3-3184-7812-53d7-aa30e14b79d1", "b3ec4a44-5643-4438-b41b-e04946436719", "f56ff74d-116d-4a75-87dc-41c309f03918", "f9aab207-d309-49b5-b941-c2912b186583", "0521c51b-d113-7e35-f1a6-c4495a2bcfcc", "4e849a58-ad34-4d6e-a065-d1e5a1ac8218", "71add294-ff24-4bbf-9067-7c56ed7c9f1a", "72fb11b6-b08c-2f02-d82b-f60f52394903", "97eaf0dc-380b-4039-aeb7-dde39942a9d6", "28a0b4c8-3ad3-451c-a957-28aef5e3d8b5", "7ae4d70f-08f1-4586-965f-5a32fbe21591", "ded71262-d17f-3799-e053-2995a90a5427", "015b1c8f-9d5b-4afc-a55c-1a731b5fc72a", "0769e47f-f8f1-4b1c-a8cc-7c8385c74070", "36adb053-3189-4c91-87dd-e122a2c8e812", "419659f9-098a-4a18-8bba-cd45157bfa50", "4b3b389d-a151-d851-cb05-64eb49979e5e", "54fd9f84-9c67-4846-b79d-eb9e6720a315", "73c36634-a70f-4641-910f-6cdda7fbcd36", "87a2aa9b-c681-41c7-8a59-b359efd443cb", "934601b6-fbba-43c4-a8ef-7a7dfe9f9a51", "ac10cf46-1dcc-483a-83d6-2fcb9896cc19", "db2d75ea-5924-4b7f-a92d-d4847a010d52", "0cb2949a-baf2-4276-a27b-8f3cc4b9a658", "38bd8e13-591e-f11b-7d8a-11717c56493c", "3c34fa4b-be9f-4aa6-ab6b-775b528a8949", "40a75dc7-49b7-5c9d-6c5f-d4682ec6922e", "548629d3-8d93-465d-b6ac-2a42bc0baebf", "7e0d319c-6917-45c4-b7e1-e870fc3fcea5", "85ece978-3cfb-4c09-bf0f-3217fda8e7d4", "dcfe8e94-9c88-464e-9a80-3baa9c4755d9", "61206416-e0c1-44d7-ad35-feb629361ba9", "64a62f09-19a9-4281-a55d-451fd33711c1", "8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56", "a5df7dac-00f4-4d97-9586-cde3055890ac", "b377cb0b-14b2-04bb-f276-fd69a257f9ca", "22b4492d-7afe-410f-97bf-57e4a57b1c27", "43ea758b-6cea-44a2-b4d6-8f99211c8826", "a1b1c61b-d4fe-433d-ad31-0b11758976fa", "b9683a94-fd44-4364-be0e-477ca1a29aba", "2f2b26fe-dbc2-4185-8a27-6b166dd49ba2", "344b5548-e5c0-45bf-bc3f-73af50bd5913", "ec9d8dab-480c-49bc-bdbb-bebcc7676d01", "1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c", "38082e59-c509-4be5-b29c-33a97565df1c", "6361a492-782f-4608-a20f-1bd86afbd864", "a5ec923a-dbc7-43e0-b3b8-f61dcaa6765d", "b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a", "fde12bf8-3e3b-4813-a8c4-4385e7de8204" ], "package_ndc": [ "46122-281-04", "46122-281-74", "64380-183-01", "64380-183-02", "64380-182-01", "64380-182-02", "63981-915-55", "57483-740-01", "57483-740-42", "51660-029-44", "51660-029-14", "51660-029-27", "70677-1275-2", "70677-1275-1", "70677-1098-1", "57896-659-14", "57896-659-42", "62175-114-37", "62175-114-32", "62175-114-46", "62175-114-49", "62175-118-49", "62175-118-32", "62175-118-46", "62175-118-37", "62175-118-43", "62175-136-32", "62175-136-46", "62175-136-37", "62175-136-43", "62175-136-49", "0363-1008-05", "0363-1008-61", "0363-1008-62", "0781-2785-31", "0781-2785-01", "0781-2785-10", "0781-2790-10", "0781-2790-01", "0781-2790-92", "0781-2790-31", "70000-0521-1", "70000-0521-3", "70000-0521-4", "70000-0521-2", "62135-559-30", "62135-530-30", "62135-530-90", "68391-103-55", "69842-941-05", "69842-941-61", "69842-941-62", "69842-941-01", "69842-941-03", "72036-981-14", "72036-981-42", "63548-8040-4", "63548-8040-8", "63548-8040-2", "69618-054-42", "53943-016-05", "53943-016-62", "82501-0915-0", "0113-0915-74", "0113-0915-30", "0113-0915-55", "0113-0915-01", "0113-0915-03", "67091-464-14", "58602-850-05", "58602-850-62", "57483-840-01", "57483-840-42", "72288-047-01", "72288-047-03", "79481-0061-1", "79481-0061-3", "41250-915-74", "41250-915-30", "41250-915-55", "41250-915-01", "41250-915-02", "41250-915-03", "68391-915-55", "59779-503-30", "59779-503-55", "59779-503-74", "59779-503-02", "59779-503-01", "59779-503-03", "37808-401-03", "37808-401-01", "59640-047-01", "59640-047-03", "82009-022-10", "11673-346-03", "55315-996-74", "55315-996-04", "49035-915-30", "49035-915-55", "49035-915-74", "49035-915-01", "49035-915-03", "30142-992-14", "30142-992-28", "42507-164-42", "79481-0281-0", "79481-0281-1", "55910-915-30", "55910-915-74", "55910-915-02", "55910-915-01", "55910-915-03", "36800-915-74", "36800-915-30", "36800-915-55", "36800-915-03", "36800-915-01", "55910-712-01", "55910-712-03", "65841-759-06", "65841-759-16", "65841-759-01", "65841-759-05", "65841-759-10", "65841-760-06", "65841-760-16", "65841-760-01", "65841-760-05", "65841-760-10", "65841-761-06", "65841-761-16", "65841-761-01", "65841-761-05", "65841-761-10", "80136-852-03", "80136-852-42", "59726-744-42", "59726-744-14", "51316-271-01", "51316-271-03", "63548-2970-4", "63548-2970-8", "63548-2970-2", "72476-473-01", "72476-473-03", "0363-1819-55", "0363-1819-74", "58602-826-05", "58602-826-61", "58602-826-62", "41163-915-74", "41163-915-30", "41163-915-55", "41163-915-01", "72559-014-06", "72559-014-07", "72559-014-36", "72559-014-09", "0113-1723-03", "0113-1723-01", "41520-939-74", "41520-939-55", "41163-634-74", "51407-814-01", "51407-814-05", "51407-814-30", "51407-814-90", "51407-664-01", "51407-664-05", "51407-664-00", "0363-9980-42", "0363-9980-28", "0363-9980-14", "45802-888-55", "45802-888-30", "69842-791-55", "69842-791-74", "46122-686-74", "46122-686-03", "37808-915-55", "37808-915-30", "37808-915-74", "37808-915-01", "37808-915-03", "63548-4080-4", "63548-4080-8", "63548-4080-2", "68001-441-55", "68001-441-98", "68001-441-39", "68001-441-40", "70000-0723-1", "70000-0723-3", "70000-0723-2", "55681-306-14", "55681-306-42", "62756-377-21", "62756-377-11", "62756-377-12", "62756-377-70", "62756-377-96", "62756-377-79", "68382-411-06", "68382-411-16", "68382-411-01", "68382-411-05", "68382-411-10", "68382-412-06", "68382-412-16", "68382-412-01", "68382-412-05", "68382-412-10", "68382-500-06", "68382-500-16", "68382-500-01", "68382-500-05", "68382-500-10", "49035-119-01", "49035-119-03", "79903-305-14", "79903-305-28", "79903-305-41", "0781-2234-10", "0781-2234-01", "0781-2234-31", "0363-6101-01", "0363-6101-03", "55910-713-74", "55910-713-30", "55910-713-55", "57483-120-42", "57483-120-14", "60505-0145-0", "60505-0145-2", "60505-0145-1", "60505-0145-3", "60505-0145-7", "60505-0065-0", "60505-0065-2", "60505-0065-5", "60505-0065-1", "60505-0065-8", "60505-0065-3", "60505-0065-7", "60505-3952-3", "60505-3952-8", "60505-0146-0", "60505-0146-9", "60505-0146-2", "60505-0146-1", "41250-349-74", "41250-349-55", "70677-0148-1", "0363-0915-30", "0363-0915-55", "0363-0915-74", "0363-0915-01", "0363-0915-03", "11822-0061-1", "11822-0061-4", "83324-011-14", "83324-011-42", "11822-0453-1", "11822-0453-2", "11822-0453-3", "0536-1322-88", "0536-1322-71", "0536-1322-13", "63941-997-42", "63941-997-14", "59726-740-42", "0113-6010-00", "0113-6010-03", "79903-377-14", "79903-377-42", "0113-0520-55", "0113-0520-74", "31722-528-30", "31722-528-01", "31722-527-30", "31722-527-01", "37808-569-45", "37808-569-82", "37808-569-41", "0363-0007-03", "0363-0007-01", "30142-077-01", "30142-077-05", "21130-991-44", "21130-991-28", "59726-298-14", "51316-843-01", "51316-843-03", "21130-128-55", "21130-128-74", "56062-401-01", "56062-401-03", "70677-1104-1", "70677-1104-2", "68196-700-01", "68196-700-03", "69230-318-35", "69230-318-36", "69230-318-37", "69230-318-32", "69230-318-33", "69230-318-34", "69230-318-05", "69230-318-10", "68462-395-30", "68462-395-90", "68462-395-01", "68462-395-10", "68462-396-30", "68462-396-90", "68462-396-01", "68462-396-10", "68462-397-30", "68462-397-90", "68462-397-01", "68462-397-10", "56062-915-55", "56062-915-74", "56062-915-30", "55319-219-14", "68196-915-55", "68196-915-74", "68196-915-03", "68196-915-01", "58602-837-05", "59779-580-01", "59779-580-03", "69168-476-14", "69168-476-42", "69168-476-61", "69168-476-15", "79481-3023-0", "79481-3023-1", "55111-643-30", "55111-643-01", "55111-643-05", "55111-643-79", "55111-643-78", "55111-644-30", "55111-644-01", "55111-644-05", "55111-644-10", "55111-644-77", "55111-645-30", "55111-645-34", "55111-645-01", "55111-645-05", "55111-645-10", "55111-645-79", "55111-645-78", "30142-474-01", "72288-409-05", "72288-409-01", "72288-409-61", "72288-409-03", "0536-1448-88", "0536-1448-13", "36800-121-01", "36800-121-03", "16714-714-01", "16714-715-01", "16714-715-02", "16714-715-03", "37835-001-42", "37835-001-14", "42507-414-00", "42507-414-01", "42507-414-42", "11673-018-03", "11673-018-01", "30142-394-74", "30142-394-55", "30142-593-03", "30142-593-01", "36800-601-74", "36800-601-55", "0781-2859-10", "0781-2859-01", "0781-2859-92", "0781-2859-31", "0781-2868-10", "0781-2868-01", "0781-2868-92", "0781-2868-31", "55319-037-05", "55319-037-62", "83324-141-42", "83324-141-14", "82009-183-10", "82009-023-05", "21130-783-03", "21130-783-01", "0363-6089-03", "0363-6089-01", "46122-029-74", "46122-029-03", "46122-029-04", "46122-029-99", "46122-739-74", "46122-739-03", "46122-739-04", "41250-401-03", "41250-401-01", "63548-7370-4", "63548-7370-8", "63548-7370-2", "55111-157-30", "55111-157-01", "55111-157-10", "55111-157-79", "55111-157-78", "55111-158-30", "55111-158-34", "55111-158-01", "55111-158-10", "55111-158-79", "55111-158-78", "55111-159-30", "55111-159-01", "55111-159-05", "55111-159-10", "55111-159-79", "55111-159-78", "0363-4099-01", "0363-4099-03", "11822-1190-0", "11822-1190-1", "21130-528-01", "21130-528-03", "51407-641-10", "51407-641-01", "51407-641-00", "51407-641-90", "51407-943-00", "51407-943-01", "51407-943-05", "51407-943-90", "51407-813-10", "51407-813-01", "51407-813-30", "51407-813-90", "30142-557-55", "30142-557-30", "30142-557-74", "30142-557-01", "30142-557-02", "30142-557-03", "51316-061-28", "79481-0075-3", "79481-0075-1", "37835-189-14", "37835-189-42", "43598-286-52", "43598-286-27", "43598-286-33", "43598-286-74", "43598-286-25", "43598-286-37", "43598-286-70", "43598-286-32", "46122-616-04", "72288-401-03", "72288-401-01", "72288-123-74", "72288-123-55", "59651-001-30", "59651-001-01", "59651-001-99", "59651-001-10", "59651-001-03", "59651-001-78", "59651-002-30", "59651-002-90", "59651-002-01", "59651-002-05", "59651-002-99", "59651-002-10", "59651-002-03", "59651-002-78", "59651-003-30", "59651-003-90", "59651-003-01", "59651-003-05", "59651-003-99", "59651-003-10", "59651-003-03", "59651-003-78", "11673-948-14", "11673-948-42", "41520-915-74", "41520-915-30", "41520-915-55", "41520-915-03", "67091-316-14", "70700-149-30", "70700-149-05", "70700-149-01", "70700-150-10", "70700-150-30", "70700-150-01", "70700-150-00", "70700-151-10", "70700-151-00", "55910-215-01", "55910-215-02", "55910-215-03", "16714-630-01", "16714-634-01", "16714-634-02", "16714-634-03", "16714-123-01", "16714-123-02", "16714-123-03", "72288-915-01", "72288-915-30", "72288-915-03", "72288-915-55", "72288-606-01", "72288-606-03", "21130-401-01", "21130-401-03", "79903-113-14", "79903-113-42", "10202-722-05", "69842-661-01", "69842-661-03", "11673-212-74", "11673-212-55", "42507-915-00", "42507-915-01", "42507-915-74", "42507-915-30", "42507-915-55", "42507-915-03", "43598-841-52", "43598-841-42", "55301-915-74", "55301-915-55", "63941-006-05", "63941-006-62", "57237-160-30", "57237-160-01", "57237-161-30", "57237-161-90", "57237-161-01", "57237-161-99", "57237-161-50", "57237-162-30", "57237-162-90", "57237-162-01", "57237-162-50", "57237-162-10", "0363-9510-14", "11673-915-55", "11673-915-30", "11673-915-01", "11673-915-02", "11673-915-03", "11673-915-74", "37808-354-74", "37808-354-55", "76162-470-03", "76162-470-01", "49035-983-05", "49035-983-62", "0113-1803-01", "0113-1803-03", "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": "2", "medicinalproduct": "ATORVASTATIN", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 1X/DAY", "activesubstance": { "activesubstancename": "ATORVASTATIN" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140710" } } }, { "safetyreportversion": "1", "safetyreportid": "10458602", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140917", "receiptdateformat": "102", "receiptdate": "20140917", "fulfillexpeditecriteria": "2", "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-42043BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-42043BP" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "JARDIANCE", "drugauthorizationnumb": "204629", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10472104", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140924", "receiptdateformat": "102", "receiptdate": "20140924", "fulfillexpeditecriteria": "2", "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43662BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43662BP" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "30", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Urticaria", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "JARDIANCE", "drugbatchnumb": "307160A", "drugauthorizationnumb": "204629", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "102", "drugstartdate": "20140911", "drugenddateformat": "102", "drugenddate": "20140912", "actiondrug": "1", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE.", "drugadministrationroute": "065", "drugindication": "URTICARIA", "activesubstance": { "activesubstancename": "PREDNISONE" }, "openfda": { "application_number": [ "ANDA215246", "ANDA080292", "ANDA088832", "ANDA083677", "ANDA040584", "ANDA040581", "ANDA040256", "ANDA040392", "ANDA210785", "ANDA080352", "ANDA211495", "ANDA215671", "ANDA219477", "ANDA088703", "ANDA084275", "ANDA208412", "ANDA211496", "ANDA213385", "ANDA215672", "ANDA212629", "ANDA213386", "ANDA211575", "ANDA080356", "ANDA085162", "ANDA085161" ], "brand_name": [ "PREDNISONE", "PREDNISONE DELAYED RELEASE", "PREDNISONE TABLETS, USP, 5 MG", "PREDNISONE TABLETS, USP, 10 MG", "PREDNISONE TABLETS, USP, 20 MG" ], "generic_name": [ "PREDNISONE" ], "manufacturer_name": [ "ANI Pharmaceuticals, Inc.", "Mylan Pharmaceuticals Inc.", "Par Health USA, LLC", "Strides Pharma Science Limited", "Hikma Pharmaceuticals USA Inc.", "Chartwell RX, LLC", "Aurobindo Pharma Limited", "INA Pharmaceutics Inc", "Amneal Pharmaceuticals NY LLC", "Dr. Reddys Laboratories Inc.", "Granulation Technology, Inc.", "Actavis Pharma, Inc." ], "product_ndc": [ "70954-056", "0378-0640", "0378-0641", "0378-0642", "0603-5335", "0603-5336", "0603-5337", "0603-5338", "0603-5339", "64380-782", "0054-9817", "0054-9828", "0054-9818", "62135-471", "59651-484", "74157-010", "74157-019", "0054-0017", "0054-4741", "0054-4742", "0054-4728", "0054-0018", "0054-0019", "0054-3722", "0054-3721", "0054-8739", "0054-8740", "0054-8724", "62135-553", "64380-783", "64380-835", "62135-470", "60219-1705", "60219-1706", "59651-485", "59651-486", "59651-487", "59651-488", "59651-489", "43598-886", "43598-887", "64380-784", "64380-785", "64380-949", "63561-0120", "63561-0121", "63561-0122", "60219-1707", "60219-1708", "70954-057", "70954-058", "70954-059", "70954-060", "70954-061", "0591-5052", "0591-5442", "0591-5443" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISONE" ], "rxcui": [ "198144", "198145", "312615", "312617", "198146", "763179", "763181", "763183", "763185", "1303125", "1303132", "198148", "205301", "315187" ], "spl_id": [ "08d9d724-eebf-4785-a0ac-95c049bc9488", "f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "0433f6e3-8d0e-41c4-a3e2-5ff3c555d57e", "675efef2-fa13-42d1-9460-d1e334f78a48", "249c4c6d-a058-489a-8f84-928c14bfd3f9", "45ae68aa-b969-3d1b-e063-6394a90a0a02", "6f9a9020-efd5-4f7d-90c7-11af33e93793", "463c5b39-7eb2-d396-e063-6394a90aa451", "523ad364-8d95-4679-9290-446d61f36eb5", "04b754a5-5740-f71c-e063-6294a90aef67", "c389b525-c68a-43dc-bacc-c75707b391b5", "45ae6dea-506e-55d8-e063-6394a90a0a4c", "abdf7308-9460-4e7f-a68a-2fe647e82602", "d957f055-4838-49e6-ae32-604fb3056bc4", "a9e0d98c-c1bf-62b0-67b3-3b8f8313b408", "bdf0b63b-7d6e-4799-be31-cdbf94e02145", "3c696af0-7946-dd78-e063-6394a90a71cc", "34381f6f-1b15-42c8-a8e6-af8302eb6c1e", "f662b658-7133-468c-b35a-ed6083cbff91", "6e6cf2e7-c839-4c9f-a58a-fea5023fb432" ], "spl_set_id": [ "7335a293-992b-490c-ab8a-66a7ca1eea30", "fec09050-5ac2-451b-a2b9-5a21b2def212", "10fe5a3b-84dc-4600-87c2-b80c97ce18cf", "a2c2e8ee-d222-47c5-93c2-8b44160a7e48", "263ed4fa-3c29-4abb-9cb1-bc016bd34a05", "36631112-3abb-4003-886b-9fe6d9cbe2cc", "7b33767f-a520-4470-8f3f-4e86b38d615a", "463c7cd2-c973-5c6c-e063-6394a90a09a0", "3115aef0-fd50-4ec8-a064-3effb695f3f2", "92483276-d55c-42c6-8bbc-27137ff25296", "52010a34-aadb-4561-ac4a-3ee53f5e3566", "f532c919-765d-407a-9e01-db2dc0c006f5", "0740ef68-7641-432e-bd46-4710687fc9d7", "b1ac4c92-e1fd-4015-b172-0932790ae019", "01bdc479-1f1f-af94-837c-12e7e861321a", "2ef05381-faad-4e0f-b58d-9f2236a04a2c", "a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "03228706-92b9-43c9-8d73-c73aa124c58d", "f05eb734-07e7-491c-b2e9-aae340e03750", "aa0b1582-6ef3-4697-9ea6-5391e6e57853" ], "package_ndc": [ "70954-056-10", "70954-056-20", "0378-0640-01", "0378-0640-10", "0378-0641-01", "0378-0641-10", "0378-0642-01", "0378-0642-05", "0378-0642-10", "0603-5335-21", "0603-5335-32", "0603-5336-21", "0603-5337-21", "0603-5337-32", "0603-5337-15", "0603-5337-31", "0603-5338-21", "0603-5338-28", "0603-5338-32", "0603-5338-15", "0603-5338-31", "0603-5339-21", "0603-5339-28", "0603-5339-32", "64380-782-06", "0054-9828-25", "0054-9828-31", "0054-9817-25", "0054-9817-29", "0054-9818-25", "0054-9818-29", "62135-471-90", "62135-471-18", "59651-484-01", "59651-484-99", "59651-484-78", "74157-010-30", "74157-019-30", "0054-4741-25", "0054-4741-31", "0054-4742-25", "0054-4728-25", "0054-4728-31", "0054-0017-25", "0054-0017-29", "0054-0017-20", "0054-0018-25", "0054-0018-29", "0054-0018-20", "0054-0019-20", "0054-0019-25", "0054-3722-63", "0054-3722-50", "0054-3721-44", "0054-8739-25", "0054-8740-25", "0054-8724-25", "62135-553-30", "62135-553-90", "64380-835-01", "64380-835-06", "64380-783-06", "64380-783-08", "64380-783-01", "62135-470-90", "62135-470-18", "60219-1705-1", "60219-1706-1", "60219-1706-7", "60219-1706-2", "60219-1706-3", "59651-485-01", "59651-485-78", "59651-486-01", "59651-486-99", "59651-486-78", "59651-487-01", "59651-487-05", "59651-487-78", "59651-488-01", "59651-488-05", "59651-488-78", "59651-489-01", "59651-489-78", "43598-886-01", "43598-886-30", "43598-887-01", "43598-887-30", "64380-784-01", "64380-784-07", "64380-784-08", "64380-784-06", "64380-785-06", "64380-785-07", "64380-785-08", "64380-785-01", "64380-949-06", "64380-949-01", "63561-0120-1", "63561-0120-2", "63561-0120-5", "63561-0121-1", "63561-0121-2", "63561-0121-5", "63561-0122-1", "63561-0122-2", "63561-0122-5", "60219-1707-1", "60219-1707-5", "60219-1707-2", "60219-1707-3", "60219-1708-1", "60219-1708-5", "70954-057-10", "70954-058-10", "70954-058-20", "70954-058-30", "70954-058-40", "70954-059-10", "70954-059-20", "70954-059-30", "70954-059-40", "70954-060-10", "70954-060-20", "70954-060-30", "70954-061-10", "0591-5052-01", "0591-5052-10", "0591-5052-21", "0591-5052-43", "0591-5442-01", "0591-5442-05", "0591-5442-10", "0591-5442-21", "0591-5442-43", "0591-5443-01", "0591-5443-05", "0591-5443-10" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "VB0R961HZT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BENADRYL", "drugadministrationroute": "065", "drugindication": "URTICARIA", "activesubstance": { "activesubstancename": "DIPHENHYDRAMINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "M012" ], "brand_name": [ "BENADRYL" ], "generic_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc.", "Kenvue Brands LLC" ], "product_ndc": [ "66715-6406", "66715-9706", "66715-6506", "50580-370", "50580-226" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1049630", "1049632" ], "spl_id": [ "2783d396-2842-91e9-e063-6294a90a88fe", "21716a1f-3636-bdde-e063-6394a90aab01", "57a6b529-75db-f06e-e063-6294a90a7dd3" ], "spl_set_id": [ "de2a64ce-c169-4162-b79e-d3809bea2147", "2884d2dc-2d4a-4ca6-ab73-688a80b428eb", "702f9786-7ce9-43e4-921d-e1db09612127" ], "package_ndc": [ "66715-9706-1", "66715-9706-2", "66715-9706-3", "66715-6406-2", "66715-6406-7", "66715-6406-8", "66715-6506-2", "50580-370-01", "50580-226-50", "50580-226-51", "50580-226-53", "50580-226-54", "50580-226-62", "50580-226-52", "50580-226-56", "50580-226-20", "50580-226-70", "50580-226-12", "50580-226-33" ], "unii": [ "TC2D6JAD40" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140911" } } }, { "safetyreportversion": "2", "safetyreportid": "10472465", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150528", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140924", "receiptdateformat": "102", "receiptdate": "20141027", "fulfillexpeditecriteria": "2", "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43059BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43059BP" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "4", "patientonsetageunit": "800", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Metrorrhagia", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "INSULIN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "INSULIN NOS" }, "openfda": { "brand_name": [ "INSULIN 1556" ], "generic_name": [ "INSULIN" ], "manufacturer_name": [ "Professional Complementary Health Formulas" ], "product_ndc": [ "63083-1556" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "INSULIN GLARGINE" ], "spl_id": [ "c3c5ae59-b449-474d-8b9c-80f1e5e4eb7b" ], "spl_set_id": [ "88170080-374d-456e-90bc-48e873878ce7" ], "package_ndc": [ "63083-1556-1" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JARDIANCE", "drugauthorizationnumb": "204629", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "610", "drugstartdate": "201409", "drugenddateformat": "102", "drugenddate": "20140908", "actiondrug": "1", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201409" } } }, { "safetyreportversion": "1", "safetyreportid": "10475139", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140925", "receiptdateformat": "102", "receiptdate": "20140925", "fulfillexpeditecriteria": "2", "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43667BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43667BP" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "62", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "JARDIANCE", "drugbatchnumb": "307160A", "drugauthorizationnumb": "204629", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "602", "drugstartdate": "2014", "actiondrug": "4", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFROMIN", "drugadministrationroute": "065", "drugindication": "DIABETES MELLITUS" } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201409" } } }, { "safetyreportversion": "1", "safetyreportid": "10475202", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140925", "receiptdateformat": "102", "receiptdate": "20140925", "fulfillexpeditecriteria": "2", "companynumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43668BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-43668BP" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Nausea", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Dizziness", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Pain", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "LANTUS", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "INSULIN GLARGINE" }, "openfda": { "application_number": [ "BLA021081" ], "brand_name": [ "LANTUS" ], "generic_name": [ "INSULIN GLARGINE" ], "manufacturer_name": [ "sanofi-aventis U.S. LLC" ], "product_ndc": [ "0088-2220", "0088-2219" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INSULIN GLARGINE" ], "rxcui": [ "285018", "311041", "847230", "847232" ], "spl_id": [ "4e220385-b760-4a64-a1ca-84bd2bebe448" ], "spl_set_id": [ "d5e07a0c-7e14-4756-9152-9fea485d654a" ], "package_ndc": [ "0088-2220-33", "0088-2220-34", "0088-2219-00", "0088-2219-01", "0088-2219-05" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JARDIANCE", "drugauthorizationnumb": "204629", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "TYPE 2 DIABETES MELLITUS", "drugstartdateformat": "610", "drugstartdate": "201409", "drugenddateformat": "102", "drugenddate": "20140915", "actiondrug": "1", "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "openfda": { "application_number": [ "NDA204629" ], "brand_name": [ "JARDIANCE" ], "generic_name": [ "EMPAGLIFLOZIN" ], "manufacturer_name": [ "Boehringer Ingelheim Pharmaceuticals, Inc." ], "product_ndc": [ "0597-0152", "0597-0153" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "EMPAGLIFLOZIN" ], "rxcui": [ "1545658", "1545664", "1545666", "1545668" ], "spl_id": [ "09daa78d-f417-436c-a29e-029c015ca6d6" ], "spl_set_id": [ "faf3dd6a-9cd0-39c2-0d2e-232cb3f67565" ], "package_ndc": [ "0597-0152-90", "0597-0152-07", "0597-0152-70", "0597-0152-37", "0597-0152-30", "0597-0153-37", "0597-0153-30", "0597-0153-90", "0597-0153-07", "0597-0153-70" ], "nui": [ "N0000187059", "N0000187058" ], "pharm_class_epc": [ "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]" ], "pharm_class_moa": [ "Sodium-Glucose Transporter 2 Inhibitors [MoA]" ], "unii": [ "HDC1R2M35U" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201409" } } } ] }