{ "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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PHARMACEUTICALS,INC./RIDGEFIELD-2014-BI-11915BP", "duplicate": "1", "reportduplicate": { "duplicatesource": "BOEHRINGER INGELHEIM", "duplicatenumb": "US-B.I. 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"Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "57Y76R9ATQ", "9TN87S3A3C" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NEXIUM", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG", "drugadministrationroute": "048", "drugindication": "GASTRITIS PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20101005", "drugenddateformat": "102", "drugenddate": "20110312", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE MAGNESIUM" }, "openfda": { "application_number": [ "NDA022101", "NDA021957", "NDA021153" ], "brand_name": [ "NEXIUM" ], "generic_name": [ "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-4010", "0186-5020", "0186-4020", "0186-4040", "0186-5040", "0186-4025", "0186-4050" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE" ], "rxcui": [ "606726", "606728", "606730", "606731", "692576", "692578", "861568", "861570", "861576", "861583", "1297658", "1297660", "1297761", "1297763" ], "spl_id": [ "26f66e74-b652-4b1d-bfff-62a3cc87d590" ], "spl_set_id": [ "f4853677-1622-4037-688b-fdf533a11d96" ], "package_ndc": [ "0186-5020-31", "0186-5020-54", "0186-5020-82", "0186-4010-01", "0186-4010-02", "0186-4020-01", "0186-4040-01", "0186-4040-02", "0186-5040-31", "0186-5040-35", "0186-5040-55", "0186-5040-85", "0186-5040-54", "0186-5040-82", "0186-5040-05", "0186-4025-01", "0186-4025-02", "0186-4050-01" ], "unii": [ "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "IBUPROFEN.", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "048", "drugindication": "OSTEOARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20101005", "drugenddateformat": "102", "drugenddate": "20110312", "activesubstance": { "activesubstancename": "IBUPROFEN" }, "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA207095", "ANDA220239", "ANDA206568", "ANDA217261", "ANDA204469", "ANDA207753", "ANDA079233", "ANDA079205", "ANDA206999", "ANDA075139", "NDA020402", "ANDA091625", "ANDA213794", "NDA022348", "ANDA079129", "ANDA215318", "ANDA074916", "ANDA208865", "M", "ANDA078329", "ANDA078558", "ANDA209204", "ANDA214789", "NDA018989", "ANDA071268", "ANDA071333", "NDA020603", "ANDA076460", "ANDA202300", "ANDA209207", "ANDA203599", "ANDA215311", 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IBUPROFEN", "IBUPROFEN INFANTS", "IBUPROFEN MINIS", "KOSHER MEDS", "IBUPROFEN IMMEDIATE RELEASE", "EQUATE IBUPROFEN", "FOSTER AND THRIVE CHILDRENS IBUPROFEN IB", "DYE-FREE PAIN RELIEF", "IBUPROFEN MINI DYE FREE", "DOLEX FLEX", "IBUPAK", "DYE FREE IBUPROFEN", "ADVIL LIQUI-GELS", "BETR PAIN RELIEF", "EQUALINE CHILDRENS IBUPROFEN", "CHILDRENS IBUPROFEN BUBBLEGUM", "CHILDRENS IBUPROFEN FRUIT", "CHILDRENS IBUPROFEN BLUE RASPBERRY", "CHILDRENS IBUPROFEN GRAPE", "IBUPROFEN IB", "KOSHER MEDS DYE-FREE IBUPROFEN", "TOPCARE CHILDRENS IBUPROFEN", "REXALL IBUPROFEN", "ADVIL MIGRAINE", "IBUPROFEN 200MG", "DG HEALTH IBUPROFEN", "CALDOLOR", "EQUATE IBUPROFEN CHILDRENS", "GOOD NEIGHBOR PHARMACY CHILDRENS IBUPROFEN", "BERKLEY AND JENSEN IBUPROFEN", "EQUALINE IBUPROFEN", "HENRY SCHEIN IBUPROFEN", "PROFEN IB INFANTS", "IBUPROFEN MIGRAINE", "ASSURED IBUPROFEN", "UP AND UP IBUPROFEN", "CAREONE CHILDRENS IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION", "BASIC CARE CHILDRENS IBUPROFEN", "PROFEN IB CHILDRENS", "BASIC CARE INFANTS IBUPROFEN", "ADVIL", "EQUALINE IBUPROFEN CHILDRENS", "FOSTER AND THRIVE IBUPROFEN", "IBUPROFEN PAIN RELEIVER/ FEVER REDUCER", "IBUPROFEN 24/7 LIFE BY 7-ELEVEN", "LEADER IBUPROFEN", "GOOD SENSE IBUPROFEN CHILDRENS", "INFANTS MOTRIN", "IBUPROFEN THOMPSON", "DYE-FREE IBUPROFEN", "IBUPROFEN DYE FREE", "MOTRIN INFANTS", "IBUPROFEN PAIN RELIEVER/FEVER REDUCER", "PAIN RELIEF IBUPROFEN", "PROFEN IB", "MOTRIN IB", "BETR REMEDIES IBUPROFEN", "CHILDRENS IBUPROFEN 572", "KIRKLAND SIGNATURE IBUPROFEN", "GOOD SENSE IBUPROFEN", "IBUPROFEN 200 MG", "CHILDRENS IBUPROFEN 100", "CHILDRENS FLANAX ORAL", "AMAZON BASIC CARE IBUPROFEN", "TOPCARE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION ORIGINAL BERRY FLAVOR", "UP AND UP DYE FREE INFANTS CONCENTRATED IBUPROFEN", "COUNTERACT IB", "SIGNATURE CARE CHILDRENS IBUPROFEN", "PAIN RELIEF", "CHILDRENS IBUPROFEN BUBBLEGUM DYE FREE", "RIGHT REMEDIES IBUPROFEN 200 MG", "UNISHIELD IBUPROFEN", "IBUPROFEN CA", "DYE-FREE IBUPROFEN 200", "IBUPROFEN 100", "IBUPROFEN 250", "INFANTS IBUPROFEN", "IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER", "CARE ONE IBUPROFEN", "CHILDRENS IBUPROFEN ORAL SUSPENSION, BUBBLE GUM", "GREEN GUARD IBUPROFEN RELIEF", "KIRKLAND SIGNATURE IBUPROFEN IB", "PEDIACARE CHILDRENS IBUPROFEN BERRY", "GOOD SENSE IBUPROFEN INFANTS", "INFANTS ADVIL", "CIRCLE K IBUPROFEN", "IBUPROFEN INFANTS DROPS", "CVS IBUPROFEN", "SIGNATURE CARE IBUPROFEN", "PARENTS CHOICE INFANTS IBUPROFEN", "LEADER INFANTS IBUPROFEN", "GOOD NEIGHBOR PHARMACY IBUPROFEN CHILDRENS", "TOPCARE INFANTS IBUPROFEN", "GOODNOW PAIN RELIEF", "CHILDRENS IBUPROFEN 100 DYE FREE", "FLEX-PRIN", "PAIN RELIEF - IBUPROFEN 200 MG", "DIRECT SAFETY IBUPROFEN", "IBUPROFEN, LIL DRUG STORE", "MEDIQUE AT HOME IPRIN", "IBUPROFEN FAST RELIEF MEDICINE FOR PAIN", "MIGRAINE RELIEF", "LIL DRUG STORE IBUPROFEN", "MCKESSON IBUPROFEN 200 MG", "IBUWIN FORTE", "IBUPROFEN 200", "DG HEALTH CHILDRENS IBUPROFEN", "IBUPROFEN, CIRCLE K, 50CT", "IBUPROFEN, CASEYS, 50CT", 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Perrigo Company", "Spirit Pharmaceutical LLC", "Meijer, Inc.", "TWIN MED LLC", "Better Living Brands, LLC", "Wal-Mart Stores, Inc.", "Haleon US Holdings LLC", "SAM'S WEST INC", "Dr. Reddy's Laboratories Limited", "Unifirst First Aid Corporation", "Chartwell RX, LLC", "CVS Pharmacy", "TIME CAP LABORATORIES,INC", "Kenvue Brands LLC", "Aurohealth LLC", "AptaPharma Inc.", "Chain Drug Marketing Association Inc.", "Uline", "Breeden Brothers, LLC", "FSA STORE INC.", "Amerisource Bergen", "Target Corporation", "Shield Pharmaceuticals Corp", "CVS", "Amazon.com Services LLC", "Advagen Pharma Ltd.", "WALGREEN COMPANY", "Cintas Corporation", "Sun Pharmaceutical Industries, Inc.", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Mollec Inc", "INGLES MARKETS, INC.", "BJWC", "Strides Pharma Inc.", "Pioneer Life Sciences, LLC", "Wal-Mart Stores Inc", "Strategic Sourcing Services LLC", "Bionpharma Inc.", "Grocery Outlet, Inc.", "Randob Labs., Ltd.", "CHAIN DRUG MARKETING ASSOCIATION INC.", "Amneal Pharmaceuticals of New York LLC", "Winco Foods, LLC", "Walgreens", "Pharmadel LLC", "RETAIL BUSINESS SERVICES , LLC.", "PureTek Corporation", "CHAIN DRUG MARKETING ASSOCIATION INC", "Lil Drug Store Products, Inc", "H E B", "Live Betr LLC", "Softgel Healthcare Private Limited", "United Natural Foods, Inc. dba UNFI", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd", "Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)", "Granules India Limited", "Guardian Drug Company", "WINCO FOODS, LLC", "NorthStar Rx LLC", "Major Pharmaceuticals", "Topco Associates LLC", "Dolgencorp, LLC", "Allegiant Health", "Walgreen Company", "Care One (American Sales Company)", "L.N.K. International, Inc.", "Retail Business Services, LLC", "Geri-Care Pharmaceutical Corp", "Dolgencorp Inc", "Cumberland Pharmaceuticals Inc.", "Family Dollar (FAMILY WELLNESS)", "Westminster Pharmaceuticals, LLC", "Chain Drug Marketing Association, Inc.", "VALU MERCHANDISERS COMPANY", "TIME CAP LABORATORIES, INC.", "FSA Store Inc. (Caring Mills)", "Spirit Pharmaceuticals LLC", "WR Group, Inc.", "BETTER LIVING BRANDS, LLC", "Rugby Laboratories, Inc.", "HART Health", "Henry Schein Inc.", "MARKSANS PHARMA LIMITED", "Topco Associates, LLC", "WALGREENS", "Publix Super Markets Inc", "SOLA Pharmaceuticals, LLC", "Meijer Distribution Inc", "Best Choice (Valu Merchandisers Company)", "TOPCO ASSOCIATES LLC", "Trifecta Pharmaceuticals USA LLC", "AMERISOURCE BERGEN", "RITE AID", "PAI Holdings, LLC dba PAI Pharma", "TOP CARE (Topco Associates LLC)", "Marc Glassman, Inc.", "Chain Drug Consortium", "RITE AID CORPORATION", "HEB", "Amneal Pharmaceuticals LLC", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "Pharmaceutical Associates, Inc.", "Amneal Pharmaceuticals NY LLC", "KROGER COMPANY", "Lil' Drug Store Products, Inc.", "PURACAP PHARMACEUTICAL LLC", "Thompson Safety", "FSA Store Inc. (Caring Mill)", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "Cardinal Health 110, LLC. DBA Leader", "Lidl US LLC", "BluePoint Laboratories", "WALMART INC.", "BETTER LIVING BRANDS LLC.", "Sam's West, Inc", "MARC GLASSMAN, INC.", "Strides Pharma Inc", "Chalkboard Health", "TIME CAP LABORATORIES, INC", "Family Dollar Services, Inc.", "BJWC (Berkley & Jensen / BJ's)", "Costco Wholesale Company", "Safeway", "RETAIL BUSINESS SERVICES,LLC.", "Discount Drug Mart", "Basic Drugs, Inc.", "Padagis Israel Pharmaceuticals Ltd", "Strides Pharma Science Limited", "AiPing Pharmaceutical, Inc.", "DEMOULAS SUPERMARKETS INC.", "ARMY AND AIR FORCE EXCHANGE SERVICE", "Belmora LLC", "The Kroger Co.", "WALGREEN CO.", "Puro Pharma Inc.", "Aurobindo Pharma Limited", "Melaleuca, Inc", "Costco Wholesale", "P & L Development, LLC", "Albertsons Companies", "Discount Drug Mart, Inc", "PROSTAT FIRST AID", "Wildman Business Group", "Unishield", "MEIJER DISTRIBUTION INC.", "Granules Pharmaceuticals Inc.", "TARGET CORPORATION", "Ascend Laboratories, LLC", "Safeway, Inc.", "CVS Pharmacy. 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"56b1a7c2-0afd-40c6-bda5-563e234a9f28" ], "spl_set_id": [ "ba74e3cd-b06f-4145-b284-5fd6b84ff3c9", "9ac0a64a-8666-45f7-9d4f-40fd894f7e6d" ], "package_ndc": [ "0597-0108-54", "0597-0108-60", "0597-0355-09", "0597-0355-56", "0597-0355-53", "0597-0360-55", "0597-0360-42", "0597-0360-82", "0597-0425-78", "0597-0430-18", "0597-0435-96", "0597-0440-53", "0597-0445-87", "0597-0450-16" ], "unii": [ "SC7NUW5IIT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "IBUPROFEN.", "drugindication": "RHEUMATOID ARTHRITIS", "activesubstance": { "activesubstancename": "IBUPROFEN" }, "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA074937", "ANDA210602", "ANDA202312", "ANDA075217", "ANDA091355", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA207095", "ANDA220239", "ANDA206568", "ANDA217261", "ANDA204469", 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"route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "IBUPROFEN" ], "rxcui": [ "310964", "310965", "197803", "204442", "310963", "731536", "197805", "197806", "197807", "206905", "206913", "206917", "900434", "900438", "206878", "544393", "731533", "854183", "854187", "2178273", "2178275", "153008", "854762", "197804", "201126", "792242", "1101919", "731531", "198405", "731535", "606990" ], "spl_id": [ "54eef6fc-7454-43e3-e063-6294a90a55d7", "205f36be-471e-40e2-9377-84b1ed6962df", "ec00fff0-0234-4676-a238-200176391de7", "426ad787-5608-4a65-bb9e-69843dd3c9e7", "29a1e9b5-d8dd-c566-e063-6394a90a65c1", "1c29b26b-8184-4f01-b002-285c3cf5c54e", "1f314365-45d0-40c1-806b-7a3c6ea7d283", "57c16fe3-9675-7fd6-e063-6394a90ad3e7", "b8c04a4a-027d-44ad-84f0-6fec957b9f64", "190f0279-7683-440a-aec8-7ee9445c1f9b", "127ceac7-923c-47f4-a768-47f7e46b2e97", "88500cb1-eb13-4bc3-9cb4-6c0b9557e57b", "f6080edf-c278-4721-8335-4c299adf0c9e", "cd06ffc5-4921-4b2d-88ea-939fa4daf59c", 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"42571-143-32", "42571-143-33", "42571-143-01", "42571-144-30", "42571-144-60", "42571-144-05", "42571-144-32", "42571-144-29", "42571-144-01", "42571-142-30", "42571-142-60", "42571-142-05", "42571-142-32", "42571-142-33", "42571-145-60", "42571-145-05", "50228-159-30", "50228-159-60", "50228-159-05", "50228-156-30", "50228-156-60", "50228-156-10", "50228-157-30", "50228-157-01", "50228-157-05", "50228-157-10", "50228-158-30", "50228-158-01", "50228-158-05", "50228-158-10", "82009-068-05", "82009-069-05", "60290-016-02", "60290-016-01", "60290-016-03", "60290-017-02", "60290-017-01", "60290-017-03", "60290-018-02", "60290-018-01", "60290-018-03", "60290-019-02", "60290-019-01", "60290-019-03", "23155-963-06", "23155-964-01", "23155-964-05", "23155-965-01", "23155-965-05", "23155-966-06", "83301-0028-1", "83301-0011-1", "83301-0011-2", "83301-0011-3", "83301-0012-1", "83301-0012-2", "83301-0012-3", "27808-295-01", "27808-296-01", "27808-296-02", "27808-297-01", "27808-297-02", "77771-156-60", "77771-157-01", "77771-157-05", "77771-158-01", "77771-158-05", "77771-159-60", "69557-333-01", "69557-333-02", "0591-3982-60", "0591-3983-01", "0591-3983-05", "0591-3984-01", "0591-3984-05", "0591-3985-60", "46708-267-30", "46708-267-60", "46708-267-91", "46708-267-12", "46708-268-30", "46708-268-31", "46708-268-91", "46708-268-12", "46708-268-60", "46708-268-71", "46708-269-30", "46708-269-31", "46708-269-71", "46708-269-91", "46708-269-12", "46708-269-60", "46708-270-30", "46708-270-60", "46708-270-71", "46708-270-10" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "JCX84Q7J1L" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130719" } } } ] }