{ "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": 76540 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "10004175", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140721", "fulfillexpeditecriteria": "1", "companynumb": "US-INCYTE CORPORATION-2014IN000317", "duplicate": "1", "reportduplicate": { "duplicatesource": "INCYTE", "duplicatenumb": "US-INCYTE CORPORATION-2014IN000317" }, "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { 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"drugcharacterization": "2", "medicinalproduct": "ATORVASTATIN", "activesubstance": { "activesubstancename": "ATORVASTATIN" } }, { "drugcharacterization": "2", "medicinalproduct": "BISOPROLOL", "activesubstance": { "activesubstancename": "BISOPROLOL" }, "openfda": { "application_number": [ "ANDA218303", "ANDA075474" ], "brand_name": [ "BISOPROLOL" ], "generic_name": [ "BISOPROLOL FUMARATE" ], "manufacturer_name": [ "Micro Labs Limited", "TruPharma, LLC" ], "product_ndc": [ "42571-470", "42571-471", "52817-270", "52817-271" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BISOPROLOL FUMARATE" ], "rxcui": [ "854901", "854905" ], "spl_id": [ "4cbe74e3-3af3-2b98-e063-6294a90a1c2b", "2a9e4180-cb1c-f924-e063-6394a90a60c6" ], "spl_set_id": [ "c3ee566c-74c4-45f4-a947-526a7313e326", "bba0bc2b-602f-4df1-a761-85bd3c80c7de" ], "package_ndc": [ "42571-470-30", "42571-470-01", "42571-470-05", "42571-471-30", "42571-471-01", "42571-471-05", "52817-270-10", "52817-270-30", "52817-271-10", "52817-271-30" ], "unii": [ "UR59KN573L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEVOTHYROXINE", "activesubstance": { "activesubstancename": "LEVOTHYROXINE" } }, { "drugcharacterization": "2", "medicinalproduct": "LORTAB", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\HYDROCODONE BITARTRATE" } }, { "drugcharacterization": "2", "medicinalproduct": "ASPIRIN.", "activesubstance": { "activesubstancename": "ASPIRIN" }, "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", "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)", "ASPIRIN LOW DOSE ENTERIC COATED", "PHYSICIANS CARE ASPIRIN", "ASPIRIN 325", "BAYER LOW DOSE", "MARKET BASKET EFFERVESCENT PAIN RELIEF", "BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE", "WINCO FOODS EFFERVESCENT PAIN RELIEF", "MEIJER LOW DOSE ASPIRIN", "ASPIRIN LOW STRENGTH", "LOW STRENGTH CHEWABLE ASPIRIN", "MEDIQUE PRODUCTS CHEWABLE LOW DOSE ASPIRIN", "PAIN RELIEF ASPIRIN CHEWABLE, LOW DOSE", "ASPIRIN 81MG ADULT LOW DOSE", "ECOTRIN", "EXTRA STRENGTH ASPIRIN", "LOW DOSE ASPIRIN 81MG", "NOBLEAID PAIN RELIEVER", "COATED ASPIRIN", "TOPCARE EFFERVESCENT PAIN RELIEF", "ASPIRIN 325 MG EC", "XPECT CHEWABLE ASPIRIN", "MCKESSON ASPIRIN", "GOOD SENSE EFFERVESCENT PAIN RELIEF", "MEIJER EFFERVESCENT PAIN RELIEF", "ASPIRIN CHEWABLE", "PAIN RELIEF ASPIRIN", "UP AND UP CHEWABLE ASPIRIN", "REGULAR STRENGTH ASPIRIN 325 MG", "ST. 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DBA UNFI", "NUVICARE LLC", "Thompson", "FSA Store Inc.", "ULINE", "Wildman Business Group" ], "product_ndc": [ "47682-456", "71679-302", "36800-545", "0363-0587", "63868-898", "80513-289", "37808-157", "83324-075", "53943-431", "70677-1121", "50844-600", "83324-058", "85828-372", "57237-302", "72036-252", "21130-428", "37835-571", "69396-173", "68998-146", "72476-263", "54162-940", "70000-0147", "53943-081", "50066-610", "87580-001", "49035-467", "17714-009", "59726-065", "37808-861", "70000-0253", "11822-0600", "54738-128", "63941-249", "54257-274", "83324-090", "49483-382", "0280-2090", "69168-318", "46122-691", "59961-616", "59961-620", "0574-7034", "17714-010", "41163-563", "58228-0071", "0363-0218", "42507-605", "36800-274", "57237-349", "63981-563", "57896-981", "55758-363", "21130-051", "51824-077", "0904-6783", "11822-6910", "56062-274", "17714-121", "70000-0014", "41520-157", "49035-563", "55910-765", "0280-2000", "49483-330", "49483-349", "63941-081", "24385-278", 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"0363-0563-90", "16103-366-05", "16103-366-11", "79481-6450-5", "84324-017-01", "63868-373-05", "53943-146-01", "53943-146-02", "73408-620-33", "73408-099-33", "73408-618-33", "73408-616-33", "46122-596-02", "37835-577-01", "37835-577-25", "83586-104-05", "83586-104-10", "11673-188-53", "51824-057-36", "81522-018-11", "61504-105-03", "69790-620-33", "69790-616-33", "0363-6450-14", "0363-6450-07", "0363-6450-12", "0363-6450-60", "0363-6450-32", "53943-152-01", "84269-2501-2", "84269-2501-1" ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140205" } } }, { "safetyreportversion": "3", "safetyreportid": "10005422", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20150528", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20141110", "fulfillexpeditecriteria": "1", "companynumb": "GB-AMGEN-GBRCT2014016681", "duplicate": "1", "reportduplicate": { "duplicatesource": "AMGEN", "duplicatenumb": "GB-AMGEN-GBRCT2014016681" }, "primarysource": { "reportercountry": "GB", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "68", "patientonsetageunit": "801", "patientagegroup": "6", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Lower respiratory tract infection", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Pneumonia", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE.", "drugdosagetext": "UNK", "drugindication": "GASTROOESOPHAGEAL REFLUX DISEASE", "drugstartdateformat": "610", "drugstartdate": "200802", "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", "Rite Aid Corporation", "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.", "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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PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ETANERCEPT" ], "rxcui": [ "253014", "261105", "727757", "802652", "809158", "809159", "1653223", "1653225", "2182338", "2182340", "2392140", "2392142" ], "spl_id": [ "de3ee3bd-0047-4365-a4c7-5786521a1649" ], "spl_set_id": [ "a002b40c-097d-47a5-957f-7a7b1807af7f" ], "package_ndc": [ "58406-425-41", "58406-425-34", "58406-424-01", "58406-910-01", "58406-021-01", "58406-021-04", "58406-021-96", "58406-032-01", "58406-032-04", "58406-032-96", "58406-032-90", "58406-010-01", "58406-010-04", "58406-010-96", "58406-044-01", "58406-044-04", "58406-044-96", "58406-044-24", "58406-044-90", "58406-055-01", "58406-055-04", "58406-055-96", "58406-055-90" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "OP401G7OJC" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PRAVASTATIN", "drugdosagetext": "UNK", "drugindication": "BLOOD CHOLESTEROL INCREASED", "drugstartdateformat": "610", "drugstartdate": "201304", "activesubstance": { "activesubstancename": "PRAVASTATIN\\PRAVASTATIN SODIUM" } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugdosagetext": "UNK", "drugindication": "HYPERTENSION", "drugstartdateformat": "610", "drugstartdate": "200103", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "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]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140111" } } }, { "safetyreportversion": "2", "safetyreportid": "10006586", "primarysourcecountry": "DE", "occurcountry": "DE", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140407", "fulfillexpeditecriteria": "1", "companynumb": "DE-ABBVIE-14P-062-1210540-00", "duplicate": "1", "reportduplicate": { "duplicatesource": "ABBVIE", "duplicatenumb": "DE-ABBVIE-14P-062-1210540-00" }, "primarysource": { "reportercountry": "COUNTRY NOT SPECIFIED", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "24", "patientonsetageunit": "801", "patientweight": "54", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Sudden hearing loss", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "HUMIRA", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "125057", "drugstructuredosagenumb": "160", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "2", "drugintervaldosagedefinition": "803", "drugdosageform": "INJECTION", "drugadministrationroute": "058", "drugindication": "CROHN^S DISEASE", "drugstartdateformat": "102", "drugstartdate": "20101025", "drugenddateformat": "102", "drugenddate": "20101025", "actiondrug": "4", "openfda": { "application_number": [ "BLA125057" ], "brand_name": [ "HUMIRA" ], "generic_name": [ "ADALIMUMAB" ], "manufacturer_name": [ "Cordavis Limited", "AbbVie Inc." ], "product_ndc": [ "83457-124", "83457-554", "83457-243", "83457-616", "83457-817", "0074-0124", "0074-3799", "0074-4339", "0074-9374", "0074-0243", "0074-0554", "0074-0067", "0074-2540", "0074-1539", "0074-0616", "0074-0817" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "797544", "1726844", "1726846", "1872979", "1872980", "1921009", "1921010", "1921016", "1921017", "1921238", "1921240", "727703", "727705", "763564", "763565", "825169", "825170", "1594352", "1594357", "1594358", "1655726", "1655728", "1656703", "1801277", "1801278", "1855523", "1855524", "1855526", "1855527", "1872983", "1872984", "1872985", "1872986", "1873086", "1873087", "1921244", "1921245", "1921467", "1921468", "2531133", "2531134" ], "spl_id": [ "5fe81b1a-cc31-444e-a0f1-1ea4f7334b89", "8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a" ], "spl_set_id": [ "4977567e-3525-44ac-9ff5-f1e74b053950", "608d4f0d-b19f-46d3-749a-7159aa5f933d" ], "package_ndc": [ "83457-554-02", "83457-553-01", "83457-927-01", "83457-124-02", "83457-123-01", "83457-243-02", "83457-242-01", "83457-616-02", "83457-615-01", "83457-817-02", "83457-816-01", "0074-3799-02", "0074-3799-71", "0074-3799-06", "0074-3799-03", "0074-4339-02", "0074-4339-07", "0074-4339-71", "0074-4339-73", "0074-4339-01", "0074-4339-74", "0074-9374-71", "0074-0243-02", "0074-0243-71", "0074-0554-01", "0074-0554-02", "0074-0554-04", "0074-0554-06", "0074-0554-71", "0074-0554-74", "0074-0554-73", "0074-0067-02", "0074-2540-01", "0074-2540-03", "0074-0124-74", "0074-0124-73", "0074-0124-01", "0074-0124-03", "0074-0124-02", "0074-0124-04", "0074-1539-03", "0074-0616-71", "0074-0616-02", "0074-0817-02" ] } }, { "drugcharacterization": "1", "medicinalproduct": "HUMIRA", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "125057", "drugstructuredosagenumb": "80", "drugstructuredosageunit": "003", "drugdosageform": "INJECTION", "drugadministrationroute": "058", "drugstartdateformat": "102", "drugstartdate": "20101108", "drugenddateformat": "102", "drugenddate": "20101108", "actiondrug": "4", "openfda": { "application_number": [ "BLA125057" ], "brand_name": [ "HUMIRA" ], "generic_name": [ "ADALIMUMAB" ], "manufacturer_name": [ "Cordavis Limited", "AbbVie Inc." ], 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"6bb77fd9-0f19-4f91-8eb9-33d9c6b5c471", "97b74888-4b28-4f9a-b5b9-64d23bc7e808", "d2a8dbd7-49db-4839-a5ee-0cbb39ae17ea", "4b43540c-2b08-44cb-81b8-4308dea2c141", "8d2e14e3-000c-41bb-82d4-c9a67330e0d9" ], "spl_set_id": [ "b9ef541a-93c8-4428-ba45-398aa0b327d1", "029716bd-ee1a-484c-bf1f-ec8d02d5281b", "d596ac59-b643-4181-80ba-f2db1cc3459c", "48fbc535-a33a-45ee-85ff-9d1ec9b31d9c", "3c59593b-e1a5-47cb-a82b-3e5e49205344", "a54b31cc-205d-43d3-a850-acf4b41fbc37", "257cee60-b68f-4c2b-b57d-8e4d73d17e09", "3254432e-87a4-4af0-afd1-d9e6f1b0efd4", "ddbe69f3-bd55-45f3-a64f-f60226c744c4" ], "package_ndc": [ "0013-0102-01", "0013-0102-20", "0013-0102-50", "0013-0102-60", "62135-960-01", "62135-960-05", "62135-960-10", "62135-960-31", "11534-201-01", "11534-201-07", "59762-5000-1", "59762-5000-2", "59762-5000-5", "59762-5000-6", "0093-3234-01", "0093-3234-05", "0093-3234-10", "11534-200-01", "11534-200-07", "11534-200-04", "59762-0104-1", "59762-0104-2", "59762-0104-5", "59762-0104-6", "16571-261-01", 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