{ "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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[EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ORAMORPH", "drugdosagetext": "10MG/5ML" }, { "drugcharacterization": "2", "medicinalproduct": "PEPTAC LIQUID" }, { "drugcharacterization": "2", "medicinalproduct": "PREGABALIN", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "openfda": { "application_number": [ "ANDA206912", "ANDA208113", "ANDA219593", "ANDA203459", "ANDA091157", "ANDA212604", "ANDA205321", "ANDA207623", "ANDA210432", "NDA021446", "ANDA214322", "ANDA206942", "ANDA209664", "ANDA215249", "ANDA208677", "NDA022488", "ANDA212988", "ANDA207799", "ANDA211384", "ANDA209743", "ANDA218529", "ANDA209357", "ANDA207883", "ANDA213226", "ANDA215675", "NDA209501", "ANDA216197", "ANDA212865", "ANDA206452", "ANDA213423" ], "brand_name": [ "PREGABALIN", "LYRICA", "PREGABALIN EXTENDED RELEASE", "LYRICA CR" 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Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RISEDRONATE", "drugstructuredosagenumb": "17.5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "17.5 MG, WEEKLY (17.5 MG ONCE WEEKLY, UPON GETTING UP IN THE MORNING (ON MONDAY) 1 TABLET/TIME)", "drugdosageform": "TABLET" }, { "drugcharacterization": "2", "medicinalproduct": "ELCATONIN", "drugdosagetext": "(20 UNITS ELCATONIN)/TIME WEEKLY", "drugdosageform": "INJECTION", "drugadministrationroute": "030" }, { "drugcharacterization": "2", "medicinalproduct": "ELCATONIN", "drugdosagetext": "NO. 3 FLUID THERAPY BY INTRAVENOUS DRIP AT RATE OF 500 ML EVERY 24 HOURS WHEN FEVER", "drugdosageform": "INJECTION", "drugadministrationroute": "041" } ] } }, { "safetyreportversion": "1", "safetyreportid": "10012765", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20140314", "fulfillexpeditecriteria": "1", "companynumb": "GB-PFIZER INC-2014071293", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "GB-PFIZER INC-2014071293" }, "primarysource": { "reportercountry": "GB", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "80", "patientonsetageunit": "801", "patientweight": "74", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fall", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Supraventricular tachycardia", "reactionoutcome": "2" } ], 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"drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugdosagetext": "25 MG, UNK", "drugadministrationroute": "048", "actiondrug": "1" }, { "drugcharacterization": "2", "medicinalproduct": "ALENDRONIC ACID", "drugstructuredosagenumb": "70", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "70 MG, WEEKLY" }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosagetext": "5 MG, DAILY", "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugdosagetext": "75 MG, DAILY", "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL ASPIRIN", "ASPIRIN REGULAR STRENGTH", "REGULAR STRENGTH ASPIRIN", "LOW DOSE MINIPRIN ENTERIC SAFETY COATED", "ASPIRIN DELAYED RELEASE", "GOOD NEIGHBOR PHARMACY ASPIRIN", "LEADER ASPIRIN", "CHEWABLE LOW DOSE ASPIRIN", "CIRCLE K ASPIRIN 325", "LOW DOSE ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 81MG ENTERIC COATED", "CHILDRENS ASPIRIN", "CVS EFFERVESCENT PAIN RELIEVER", "BASIC CARE ASPIRIN", "SIGNATURE SELECT EFFERVESCENT PAIN RELIEF", "TRI-BUFFERED ASPIRIN", "ASPIRIN ENTERIC COATED, REGULAR STRENGTH", "ASPIRIN LOW DOSE CHEWABLE", "ASPIRIN ENTERIC SAFETY COATED", "ASPIRIN 325 MG", "MEDIQUE AT HOME ASPIRIN", "REGULAR STRENGTH ENTERIC COATED ASPIRIN", "DYE-FREE ASPIRIN 81", "PUBLIX FAST RELIEF EFFERVESCENT - ORIGINAL FLAVOR", "BEST CHOICE EFFERVESCENT PAIN RELIEVER 36", "ASPIRIN 81 MG", "BAYER ASPIRIN ORIGINAL, TRAVEL BASIX", "BAYER ASPIRIN ORIGINAL, CVP HEALTH", "BAYER", "QUALITY CHOICE EFFERVESCENT PAIN RELIEF", "MEDLINE", "ASPI-COR", "UNISHIELD ASPIRIN", "FAMILY WELLNESS PAIN RELIEVER", "ASPIRINA CAPLETS", "ASPIRIN 81MG ENTERIC COATED LOW STRENGTH ASPIRIN REGIMEN", "EQUATE ASPIRIN CHEWABLE", "GOOD SENSE ASPIRIN", "BAYER ASPIRIN REGIMEN ENTERIC COATED", "RUGBY ASPIRIN", "ASPIRIN NSAID", "RIGHT REMEDIES LOW DOSE ASPIRIN 81MG", "ASPIRIN 50 CT", "SUNMARK ASPIRIN", "ASPIRIN PAIN RELIEF", "DIRECT SAFETY ASPIRIN", "ASPIRIN 81MG ENTERIC COATED DELAYED RELEASE", "FIRST AID DIRECT CHEWABLE ASPIRIN", "FOSTER AND THRIVE ASPIRIN", "ENTERIC COATED ASPIRIN REGULAR STRENGTH", "LIL DRUG STORE ASPIRIN 325", "DOLLAR GENERAL EFFERVESCENT PAIN RELIEVER", "ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN LOW DOSE CHEWABLE ORANGE", "ADULT LOW DOSE PAIN RELIEVER", "ASPIRIN PAIN RELIVER", "DG HEALTH ASPIRIN", "LOW DOSE CHEWABLE ASPIRIN", "ASPIRIN REGIMEN", "GREEN GUARD CHEWABLE ASPIRIN 81 MG", "ECOTRIN REGULAR STRENGTH", "GENCARE-ASPIRIN LOW DOSE PAIN RELIEVER (NSAID)", 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JOSEPH LOW DOSE ASPIRIN", "CARDIASPIRIN PROTECT", "ST. JOSEPH CHEWABLE LOW DOSE ASPIRIN", "MEDIQUE PRODUCTS ASPIRIN", "MEDI-FIRST ASPIRIN", "MEDI-FIRST PLUS ASPIRIN", "EQUALINE EFFERVESCENT PAIN RELIEVER", "ASPIRIN ENTERIC COATED LOW DOSE", "ADULT LOW STRENGTH ASPIRIN", "THOMPSON ASPIRIN", "LOW DOSE ASPIRIUN", "ULINE ASPIRIN" ], "generic_name": [ "ASPIRIN", "ASPIRIN 81 MG", "ASPIRIN 325 MG" ], "manufacturer_name": [ "Unifirst First Aid Corporation", "Health Pharma USA LLC", "Topco Associates, LLC", "Walgreen Company", "CHAIN DRUG MARKETING ASSOCIATION INC", "Advanced Rx LLC", "H E B", "Chain Drug Marketing Association, Inc.", "Discount Drug Mart Inc", "STRATEGIC SOURCING SERVICES LLC", "L.N.K. International, Inc.", "Grocery Outlet", "Rising Pharma Holdings, Inc.", "HARRIS TEETER", "BETTER LIVING BRANDS LLC.", "Bi-Mart", "Trifecta Pharmaceuticals USA LLC", "Marc Glassman, Inc.", "Care One (Retail Business Services, LLC.)", "Geritrex LLC", "Cardinal Health 110, LLC. 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(DOLLAR GENERAL & REXALL)", "VALU MERCHANDISERS COMPANY", "Geiss, Destin & Dunn Inc.", "MARC GLASSMAN, INC.", "Cardinal Health 110, LLC. dba Leader", "ARMY AND AIR FORCE EXCHANGE SERVICE", "TARGET CORPORATION", "Meijer Distribution, Inc.", "RMT HEALTH LLC", "Lil Drug Store Products, Inc", "DOLGENCORP, LLC", "Cardinal Health 107, LLC", "HART Health", "CVS PHARMACY", "Amazon.com Services LLC", "Safeway Inc.", "AAA Pharmaceutical, Inc.", "Major Pharmaceuticals", "Better Living Brands, LLC", "Publix Supermarkets, Inc.", "Hi-Tech Nutraceuticals, LLC", "WALGREENS", "PUBLIX SUPER MARKETS INC.", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Lil' Drug Store Products, Inc.", "RETAIL BUSINESS SERVICES , LLC.", "SAM'S WEST INC", "BJWC (Berkley & Jensen / BJ's)", "Medline Industries, LP", "Unishield", "Chain Drug Marketing Association", "Lidl US LLC", "Akron Pharma Inc.", "FAMILY WELLNESS SERVICES, INC.", "Kroger Company", "Topco Associates", "CVS Pharmacy", "L. Perrigo Company", "Rugby Laboratories", "Gendose Pharmaceuticals, LLC", "Hy-Vee", "Reliable 1 Laboratories LLC", "TOP CARE (Topco Associates LLC)", "TIME CAP LABORATORIES, INC", "Strive Pharmaceuticals Inc.", "HyVee Inc", "Strategic Sourcing Services LLC", "BETTER LIVING BRANDS, LLC", "JHK Inc dba American Safety & First Aid", "Meijer", "Direct Safety", "Salado Sales, Inc.", "Cintas Corp", "Geri-Care Pharmaceuticals, Corp", "Family Dollar Services Inc", "Dolgencorp, Inc", "Pinnacle RX LLC", "GOODSENSE", "Health Pharma USA, LLC", "TWIN MED LLC", "Pioneer Life Sciences, LLC", "Meijer Distribution Inc", "Dolgencorp, LLC", "Marlex Pharmaceuticals Inc.", "Sam's West Inc", "WinCo Foods, LLC", "Unifirst First Aid Corporaiton", "Safeway", "Medtech Products Inc.", "Lodaat LLC", "Acme United Corporation", "McKesson Medical-Surgical, Inc.", "DEMOULAS SUPER MARKETS, INC.", "Winco Foods, LLC", "Meijer, Inc.", "Richmond Pharmaceuticals, Inc", "Famora Inc.", "PUBLIX SUPER MARKETS INC", "FSA STORE INC.", "Pharbest Pharmaceuticals, Inc.", "Discount Drug Mart", "Dr. Wayne's", "H-E-B", "TopCare", "HHH Pharmaceuticals", "Athlete's Needs Inc", "Noble Otc LLC", "TOPCO ASSOCIATES LLC", "Cintas Corporation", "McKesson Medical-Surgical", "AMERIFOODS TRADING COMPANY", "TIME CAP LABS INC", "Perrigo Direct, Inc.", "Walmart Inc.", "Target Corporation", "Kroger", "HEB", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "Foundation Consumer Healthcare", "Aarkish Pharmaceuticals NJ Inc.", "OPMX LLC", "Foundation Consumer Healthcare LLC", "INVAHEALTH INC", "UNITED NATURAL FOODS, INC. 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"65162-577-50", "65162-577-11" ], "unii": [ "76755771U3" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LAXIDO", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 DF 1X/DAY (1-2 AT NIGHT)" }, { "drugcharacterization": "2", "medicinalproduct": "LEVOTHYROXINE", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "75 UG 1X/DAY (IN THE MORNING)" }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG 1X/DAY (IN THE MORNING)", "openfda": { "application_number": [ "NDA022032", "ANDA079182", 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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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