{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. 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[EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10005146", "primarysourcecountry": "MX", "occurcountry": "MX", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "PHHY2014MX027601", "duplicate": "1", "reportduplicate": { "duplicatesource": "SANDOZ", "duplicatenumb": "PHHY2014MX027601" }, "primarysource": { "reportercountry": "MX", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "22", "patientonsetageunit": "801", "patientweight": "69", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Phlebitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pyrexia", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "METRONIDAZOLE", "drugauthorizationnumb": "18740", "drugstructuredosagenumb": "500", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "8", "drugintervaldosagedefinition": "805", "drugdosagetext": "500 MG, Q8H", "drugadministrationroute": "042", "actiondrug": "5", "openfda": { "application_number": [ "ANDA070772", "NDA018657", "ANDA216750", "ANDA070027", "ANDA070033", "ANDA077819", "ANDA078178", "ANDA206560", "ANDA215794", "ANDA212435", "ANDA216692", "NDA020743", "ANDA220095", "ANDA079065", "ANDA206191", "ANDA212646", "ANDA077197", "ANDA076522", "ANDA077547", "ANDA090222", "ANDA209794", "ANDA213648", "ANDA203974", "NDA020334", "ANDA079067", "NDA020531", 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LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. 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Diuretic [EPC]" ], "unii": [ "7LXU5N7ZO5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "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 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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", 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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. 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"72657-129-30", "72657-129-45", "72657-129-60", "72657-129-70", "72657-129-90", "72657-129-08", "72657-129-14", "72657-129-15", "72657-129-18", "72657-129-24", "72657-129-03", "72657-129-35", "72657-129-04", "72657-129-81", "72657-129-82", "72657-129-84", "72657-129-86", "72657-129-41", "72657-130-05", "72657-131-89", "65162-684-86", "65162-684-90", "65162-045-03", "65162-045-50", "51316-764-65", "65162-003-86", "70677-1279-2", "70677-1279-3", "70677-1279-4", "70677-1279-5", "70677-1279-1" ], "unii": [ "64O047KTOA", "YO7261ME24" ], "nui": [ "N0000000190", "N0000175587" ], "pharm_class_moa": [ "Histamine H1 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-1 Receptor Antagonist [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VENTOLIN /00139501/", "drugbatchnumb": "UNKNOWN", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5" } ] } } ] }