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"drugstructuredosagenumb": "800", "drugstructuredosageunit": "003", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "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", 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CARE IBUPROFEN", "XPECT 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", 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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. 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Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Harris Teeter, LLC", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. 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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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myeloma", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "POMALYST", "drugbatchnumb": "C0016C", "drugauthorizationnumb": "204026", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 MILLIGRAM", "drugdosageform": "Capsules", "drugadministrationroute": "048", "drugindication": "PLASMA CELL MYELOMA", "drugstartdateformat": "102", "drugstartdate": "20140117", "drugenddateformat": "602", "drugenddate": "2014", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "POMALIDOMIDE" }, "openfda": { "application_number": [ "NDA204026" ], "brand_name": [ "POMALYST" ], "generic_name": [ "POMALIDOMIDE" ], "manufacturer_name": [ "Celgene Corporation" ], "product_ndc": [ "59572-501", "59572-502", 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"1745091" ], "spl_id": [ "eedfe43b-1019-19a0-e053-2995a90a7696" ], "spl_set_id": [ "db0092f5-02a0-4076-ac32-969f075a6ab1" ], "package_ndc": [ "61959-001-01", "61959-001-30" ], "nui": [ "N0000175682", "M0000897", "N0000175426", "N0000175976" ], "pharm_class_epc": [ "Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]" ], "pharm_class_cs": [ "Amides [CS]" ], "pharm_class_pe": [ "Local Anesthesia [PE]" ], "unii": [ "98PI200987" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HYDROMORPHONE HCL", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "HYDROMORPHONE HYDROCHLORIDE" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140114" } } }, { "safetyreportversion": "6", "safetyreportid": "10020122", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140319", "receiptdateformat": "102", "receiptdate": "20150430", "fulfillexpeditecriteria": "1", "companynumb": "US-AMGEN-USASP2014005797", "duplicate": "1", "reportduplicate": { "duplicatesource": "AMGEN", "duplicatenumb": "US-AMGEN-USASP2014005797" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "64", "patientonsetageunit": "801", "patientagegroup": "5", "patientweight": "84", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Transferrin abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Haemoglobin abnormal", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Non-neutralising antibodies positive", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Anti-erythropoietin antibody positive", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Serum ferritin abnormal", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "EPOGEN", "drugauthorizationnumb": "103234", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "25000 UNIT, 3 TIMES/WK", "drugdosageform": "UNKNOWN FORMULATION", "drugadministrationroute": "042", "drugindication": "NEPHROGENIC ANAEMIA", "drugstartdateformat": "610", "drugstartdate": "201011", "actiondrug": "5", "activesubstance": { "activesubstancename": "ERYTHROPOIETIN" }, "openfda": { "application_number": [ "BLA103234" ], "brand_name": [ "EPOGEN" ], "generic_name": [ "EPOETIN ALFA" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-126", "55513-267", "55513-148", "55513-144", "55513-283", "55513-478" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "EPOETIN" ], "rxcui": [ "205912", "205917", "205921", "205923", "212218", "239998", "239999", "240000", "240377", "241999", "1721684", "1721685" ], "spl_id": [ "bf994196-5149-4089-b1fc-c4f0cb8744b3" ], "spl_set_id": [ "1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5" ], "package_ndc": [ "55513-126-01", "55513-126-10", "55513-126-20", "55513-267-01", "55513-267-10", "55513-267-20", "55513-148-01", "55513-148-10", "55513-148-20", "55513-144-01", "55513-144-10", "55513-144-20", "55513-283-01", "55513-283-10", "55513-283-20", "55513-478-01", "55513-478-10", "55513-478-20" ], "unii": [ "64FS3BFH5W" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HECTOROL", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "DOXERCALCIFEROL" } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D /00107901/", "drugdosagetext": "UNK", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "ERGOCALCIFEROL" } }, { "drugcharacterization": "2", "medicinalproduct": "VENOFER", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "2", "drugintervaldosagedefinition": "803", "drugdosagetext": "50 MG, EVERY OTHER WEEK", "drugadministrationroute": "042", "activesubstance": { "activesubstancename": "IRON SUCROSE" }, "openfda": { "application_number": [ "NDA021135" ], "brand_name": [ "VENOFER" ], "generic_name": [ "IRON SUCROSE" ], "manufacturer_name": [ "Fresenius Medical Care Holdings, Inc.", "American Regent, Inc." ], "product_ndc": [ "49230-530", "49230-534", "0517-2310", "0517-2325", "0517-2340" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "IRON SUCROSE" ], "rxcui": [ "1741267", "1741268", "1741270", "1741271", "1741261", "1741263" ], "spl_id": [ "e12cb876-ae80-416b-9bd3-a1cc83c9e666", "500b09f8-36f1-4842-8d07-246fea7bdfd0", "215e70bd-ace6-4a58-a31f-ca899ec2eca5" ], "spl_set_id": [ "f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040", "626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a", "b998ef36-81fa-40a1-9cd1-6d6156f91564" ], "package_ndc": [ "49230-530-01", "49230-530-10", "49230-530-25", "49230-534-01", "49230-534-10", "49230-534-25", "0517-2325-01", "0517-2325-10", "0517-2340-01", "0517-2340-10", "0517-2340-25", "0517-2310-01", "0517-2310-05", "0517-2340-99" ], "nui": [ "M0011718", "N0000177913" ], "pharm_class_cs": [ "Iron [CS]" ], "pharm_class_epc": [ "Parenteral Iron Replacement [EPC]" ], "unii": [ "FZ7NYF5N8L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RENVELA", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "SEVELAMER CARBONATE" }, "openfda": { "application_number": [ "NDA022318", "NDA022127" ], "brand_name": [ "RENVELA" ], "generic_name": [ "SEVELAMER CARBONATE" ], "manufacturer_name": [ "Genzyme Corporation" ], "product_ndc": [ "58468-0131", "58468-0133", "58468-0132", "58468-0130" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SEVELAMER CARBONATE" ], "rxcui": [ "749206", "749210", "861370", "861373", "861375", "861377" ], "spl_id": [ "cb4453a2-c47b-4352-839f-f022ac67368e" ], "spl_set_id": [ "e6328460-a57b-450b-a48c-6dcd4b476360" ], "package_ndc": [ "58468-0131-1", "58468-0131-2", "58468-0131-3", "58468-0131-4", "58468-0131-5", "58468-0133-1", "58468-0132-1", "58468-0132-2", "58468-0130-1", "58468-0130-2" ], "unii": [ "9YCX42I8IU" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130701" } } }, { "safetyreportversion": "2", "safetyreportid": "10020319", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140319", "receiptdateformat": "102", "receiptdate": "20150427", "fulfillexpeditecriteria": "1", "companynumb": "US-ROCHE-1361297", "duplicate": "1", "reportduplicate": { "duplicatesource": "ROCHE", "duplicatenumb": "US-ROCHE-1361297" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "16", "patientonsetageunit": "801", "patientweight": "44.4", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Oedema peripheral", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Injection site pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Periorbital oedema", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Eczema", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Upper respiratory tract infection", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Headache", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Renal failure", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Growth retardation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Nasal congestion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Cushingoid", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Pyrexia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Granuloma", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Malaise", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "NUTROPIN AQ", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "020522", "drugstructuredosagenumb": "1.5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "058", "actiondrug": "4", "activesubstance": { "activesubstancename": "SOMATROPIN" } }, { "drugcharacterization": "2", "medicinalproduct": "FERRLECIT (UNITED STATES)", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugdosagetext": "PRN", "drugadministrationroute": "042" }, { "drugcharacterization": "1", "medicinalproduct": "NUTROPIN AQ", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "020522", "drugstructuredosagenumb": "3.6", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "058", "actiondrug": "4", "activesubstance": { "activesubstancename": "SOMATROPIN" } }, { "drugcharacterization": "2", "medicinalproduct": "FERROUS SULFATE", "drugstructuredosagenumb": "325", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "FERROUS SULFATE\\FERROUS SULFATE, DRIED" }, "openfda": { "brand_name": [ "FERRUM SULPHURICUM", "FERROUS SULFATE" ], "generic_name": [ "FERROUS SULFATE" ], "manufacturer_name": [ "Boiron", "Richmond Pharmaceuticals, Inc.", "Richmond Pharmaceuticals Inc." ], "product_ndc": [ "0220-2113", "54738-963", "0220-2111" 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"patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Peritonitis bacterial", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Peritonitis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Cough", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Malaise", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "DIANEAL PD2", "drugbatchnumb": "C903799", "drugauthorizationnumb": "17512024", "drugstructuredosagenumb": "2000", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "8", "drugintervaldosagedefinition": "805", "drugdosagetext": "1600 ML", "drugdosageform": "SOLUTION FOR PERITONEAL DIALYSIS", "drugadministrationroute": "033", "drugindication": "RENAL FAILURE CHRONIC", "drugstartdateformat": "102", "drugstartdate": "20121210", "actiondrug": "1" }, { "drugcharacterization": "1", "medicinalproduct": "DIANEAL PD2", "drugbatchnumb": "C903799", "drugauthorizationnumb": "17512024", "drugindication": "PERITONEAL DIALYSIS", "actiondrug": "1" }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "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": "CALCIUM CARBONATE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "M001", "M", "part331", "M022", "Part331" ], "brand_name": [ "WINCO FOODS ANTACID ULTRA STRENGTH", "EXTRA STRENGTH SMOOTH ANTACID", "KROGER WILD BERRY ANTACID CHEWS", "NUTRALOX", "EXTRA STRENGTH ANTACID", "EXTRA STRENGTH ANTACID ASSORTED BERRIES", "KROGER ULTRA STRENGTH ASSORTED BERRY", "SEYIP", "FAMILY WELLNESS EXTRA STRENGTH SMOOTH ANTACID 173BF", "CVS WILD BERRY ANTACID CHEWS", "MEIJER BERRY LIME ANTACID HBG CHEWS", "EXTRA STRENGTH ANTACID SMOOTH DISSOLVING - BERRY FUSION FLAVORS", "TOPCARE ANTACID CALCIUM EXTRA STRENGTH", "EXTRA STRENGTH ANTACID ASSORTED FRUIT", "ANTACID", "MEDIQUE BAN-ACID MAXIMUM STRENGTH 750", "QUALITY CHOICE ANTACID ASSORTED FRUIT", "MEIJER EXTRA STRENGTH ANTACID ASSORTED BERRIES", "MEIJER ANTACID EXTRA STRENGTH ASSORTED BERRY", "EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUITS", "EXCHANGE SELECT ANTACID SOFT CHEWS 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"ALKA-SELTZER HEARTBURN RELIEFCHEWS", "RITE AID WILD BERRY ANTACID CHEWS", "FAMILY WELLNESS ANTACID RELIEF CHEWS", "TUMS CHEWY BITES ORANGE AND CREAM ES", "WALGREENS CHERRY BERRY LIME ANTACID HBG 54CT", "EXCHANGE SELECT EXTRA STRENGTH ANTACID ASSORTED BERRIES", "TUMS EXTRA STRENGTH SUGAR-FREE", "EQUALINE ULTRA STRENGTH ANTACID ASSORTED BERRY ULTRA STRENGTH ASSORTED FRUIT ANTACID", "EXTRA STRENGTH ASSORTED BERRY ANTACID", "ANTACID FLAVOR CHEWS", "KROGER EXTRA STRENGTH ASSORTED FRUIT", "CITRUS FLAVORED ANTACID", "TARGET ANTACID - ANTI-GAS RELIEF CHEWS", "FAMILY WELLNESS EXTRA STRENGTH ANTACID EXTRA STRENGTH ASSORTED FRUIT ANTACID", "CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH", "HEB ULTRA STRENGTH ASSORTED FRUITS", "EQUQLINE EXTRA STRENGTH ANTACID ASSORTED FRUIT", "TOPCARE CHERRY BERRY LIME ANTACID HBG", "ULTRA STRENGTH ASSORTED FRUIT ANTACID", "AMAZON BASICS CHERRY ANTACID SC", "ALKA-SELTZER ULTRA STRENGTH HEARTBURN RELIEFCHEWS", "CVS PHARMACY ASSORTED BERRY ANTACID", "ALKA-SELTZER HEARTBURN RELIEF PEPPERMINT", "MARC GLASSMAN EXTRA STRENGTH", "PUBLIX REGULAR STRENGTH PEPPERMINT FLAVOR", "QUALITY CHOICE ASSORTED BERRIES EXTRA STRENGTH", "HEB WILD BERRY ANTACID CHEWS", "TARGET WILD BERRY ANTACID CHEWS 60CT", "MINT ANTACID 100", "MINT ANTACID 250", "CHERRY ANTACID", "MEDIQUE ALCALAK", "MEDI-FIRST ANTACID", "MEDI-FIRST PLUS ANTACID", "QUALITY CHOICE", "FOSTER AND THRIVE EXTRA STRENGTH SUGAR FREE ANTACID ORANGE", "MEIJER ULTRA STRENGTH ANTACID ASSORTED FRUIT", "TOPCARE ULTRA STRENGTH ANTACID ASSORTED BERRY", "BI-MART ULTRA STRENGTH ANTACID PEPPERMINT", "CALCIUM CARBONATE CHEWABLE ANTACID", "GOODSENSE REGULAR STRENGTH ANTACID", "BEST CHOICE REGULAR STRENGTH", "TARGET BERRY LIME HBG CHEWS", "TUMS CHEWY BITES VANILLA AND MINT", "DG HEALTH EXTRA STRENGTH ANTACID", "TOPCARE EXTRA STRENGTH ANTACID ASSORTED FRUIT EXTRA STRENGTH ANTACID ASSORTED FRUIT", "CALCIUM CARBONATE 1250 MG", "MEIJER EXTRA STRENGTH WINTERGREEN FLAVOR", "FAMILY WELLNESS ULTRA STREGTH ANTACID 171AB", "EXTRA STRENGTH ANTACID ORANGE CREAM SUGAR FREE", "R COS", "CALCIUM CARBONATE 10 GR (648 MG)", "HEB EXTRA STREGTH ANTACID", "KROGER EXTRA STRENGTH ASSORTED BERRY", "PUBLIX REGULAR STRENGTH ASSORTED FRUIT", "BEST CHOICE EXTRA STRENGTH ASSORTED BERRY", "GENEXA KIDS TUMMY RELIEF", "EXCHANGE SELECT ANTACID TROPICAL FRUIT", "MEIJER REGULAR STRENGTH ASSORTED FRUIT", "HEB ANTACID EXTRA STRENGTH ASSORTED BERRY", "THOMPSON ANTACID", "TUMS CHEWY DELIGHTS", "MEIJER EXTRA STRENGTH ANTACID", "GOODSENSE REGULAR STRENGTH ANTACID PEPPERMINT", "ULTRA STRENGTH ANTACID PEPPERMINT", "FOSTER AND THRIVE REGULAR STRENGTH ANTACID PEPPERMINT", "HEB REGULAR STRENGTH PEPPERMINT FLAVOR", "CHERRY ANTACID RELIEF CHEW", "GUARDIAN EXTRA STRENGTH SMOOTH ALKUM ANTACID 173BF", "HEB EXTRA STRENGTH TROPICAL FRUIT", "FAMILY WELLNESS ULTRA STRENGTH ASSORTED FRUIT ANTACID ULTRA STRENGTH ASSORTED FRUIT ANTACID", "TOPCARE ANTACID CALCIUM REGULAR STRENGTH", "MARC GLASSMAN ULTRA STRENGTH", "BM CALCIUM CARBONATE (CALC CARB)", "KROGER EXTRA STRENGTH SMOOTH ANTACID ASSORTED BERRY", "ANTACID- CALCIUM CARBONATE", "TUMS EX", "FOSTER AND THRIVE EXTRA STRENGTH ANTACID 127AF EXTRA STRENGTH ANTACID ASSORTED FRUIT", "HEB REGULAR STRENGTH ASSORTED FRUIT", "TUMS REGULAR STRENGTH", "GOOD SENSE ANTACID SOFT CHEW", "BEST CHOICE ASSORTED FRUIT", "QUALITY CHOICE REGULAR STRENGTH PEPPERMINT FLAVOR" ], "generic_name": [ "CALCIUM CARBONATE", "ANTACID" ], "manufacturer_name": [ "WINCO FOODS, LLC", "Retail Business Services, LLC.", "Kroger", "HART Health", "Grocery Outlet, Inc.", "Rite Aid", "KROGER COMPANY", "Seaip co., Ltd", "Family Dollar Services, Inc.", "CVS Pharmacy", "Meijer", "TARGET CORPORATION", "Topco Associates LLC", "Hyvee Inc", "Meijer Distribution Inc", "Unifirst First Aid Corporation", "CHAIN DRUG MARKETING ASSOCIATION", "MEIJER DISTRIBUTION INC", "MEIJER DISTRIBUTION INC.", "Good Sense (Geiss, Destin & Dunn, Inc.)", "Xiamen Kang Zhongyuan Biotechnology Co., Ltd.", "BETTER LIVING BRANDS LLC", "Target", "SAFEWAY", 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EFFERVESCENT PAIN RELIEF", "ASPIRIN CHEWABLE", "PAIN RELIEF ASPIRIN", "UP AND UP CHEWABLE ASPIRIN", "REGULAR STRENGTH ASPIRIN 325 MG", "ST. 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. DBA Leader", "DISCOUNT DRUG MART", "Genomma Lab USA", "Wisdrug AG", "Wal-Mart Stores Inc", "Advance Pharmaceutical Inc.", "P & L Development, LLC", "H. E. BUTT GROCERY COMPANY", "Rite Aid Corporation", "Richmond Pharmaceuticals, Inc.", "Valu Merchandisers Company", "Magno-Humphries, Inc.", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Time-Cap Labs, Inc", "Bayer HealthCare LLC.", "Allegiant Health", "Amerisource Bergen", "Bellegrove Medical Supply, Inc.", "Padagis US LLC", "United Natural Foods, Inc. dba UNFI", "PROSTAT FIRST AID", "HYVEE INC", "Topco Associates LLC", "COSTCO WHOLESALE CORPORATION", "Geri-Care Pharmaceutical Corp", "Pharmadel LLC", "Better Living Brands LLC", "New World Imports, Inc", "MAJOR PHARMACEUTICALS", "Publix Super Markets Inc", "CARDINAL HEALTH, INC.", "FOODHOLD U.S.A., LLC", "Dolgencorp, Inc. (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. 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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Aggregation Inhibitor [EPC]" ], "unii": [ "R16CO5Y76E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VENOFER", "activesubstance": { "activesubstancename": "IRON SUCROSE" }, "openfda": { "application_number": [ "NDA021135" ], "brand_name": [ "VENOFER" ], "generic_name": [ "IRON SUCROSE" ], "manufacturer_name": [ "Fresenius Medical Care Holdings, Inc.", "American Regent, Inc." ], "product_ndc": [ "49230-530", "49230-534", "0517-2310", "0517-2325", "0517-2340" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "IRON SUCROSE" ], "rxcui": [ "1741267", "1741268", "1741270", "1741271", "1741261", "1741263" ], "spl_id": [ "e12cb876-ae80-416b-9bd3-a1cc83c9e666", "500b09f8-36f1-4842-8d07-246fea7bdfd0", "215e70bd-ace6-4a58-a31f-ca899ec2eca5" ], "spl_set_id": [ "f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040", "626dc9e5-c6b4-4f9c-9bf4-774fd3ae619a", "b998ef36-81fa-40a1-9cd1-6d6156f91564" ], "package_ndc": [ "49230-530-01", "49230-530-10", 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Inc.", "NorthStar RxLLC", "Zyla Life Sciences US LLC", "Zydus Lifesciences Limited", "Amneal Pharmaceuticals NY LLC", "Zyla Life Sciences US Inc.", "ANI Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Amneal Pharmaceuticals LLC", "KVK-Tech, Inc.", "Camber Pharmaceuticals, Inc." ], "product_ndc": [ "62135-068", "63323-659", "70710-1852", "70710-1958", "68462-302", "68462-406", "0054-1950", "72603-281", "69344-101", "70771-1766", "62135-067", "69238-2086", "69344-102", "70954-637", "68462-325", "72865-148", "72865-149", "65162-506", "10702-016", "31722-565", "31722-542", "31722-543", "31722-051" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS", "RECTAL" ], "substance_name": [ "INDOMETHACIN" ], "rxcui": [ "197818", "346508", "197819", "197817", "206971", "310991", "206969", "310992" ], "spl_id": [ "458c9652-de42-bf50-e063-6394a90a3325", "8669be4e-809a-470d-a081-837834bd9eb8", "796d8f36-e2ba-4f03-8e37-28590adfaed0", "472b97d6-5eef-4fc5-8a01-b5466d00715e", "bcf62935-0bd5-479f-9680-c5b4eba5a529", "536da97c-1c9d-4cf8-ae7a-a263cc59c8e6", "464c32f6-9d5f-eb21-e063-6294a90a8bd8", "58959f55-f324-4433-97fc-c3b1b7c199be", "6d0a7b56-9d42-4fe8-9166-408267ded644", "4ada9870-cf14-4c61-892f-6ad9349c31de", "3143c8a1-9d17-9eb6-e063-6394a90ab16b", "18ca75fc-a45c-42a4-b966-9d3ae4821de8", "46b85569-0280-40b8-8230-939ec20c8c1a", "462a8532-9cea-682f-e063-6394a90a50e4", "a2bb8e18-c1c2-4f73-ac4d-139a21488902", "e729f88c-b2c8-4462-98be-7184de95b01d", "f26f7451-69b2-99d7-e053-2a95a90af7a1", "083ef389-551a-48c5-9a92-f16fb6270ae4", "30a4fdec-3f89-034c-e063-6294a90aa786", "349e2ce2-f399-926c-e063-6294a90a9185", "349de484-29cd-3e15-e063-6394a90a5aa5", "3de4c874-6157-dc17-e063-6394a90a7ae2" ], "spl_set_id": [ "d35bafd6-076d-4b94-bb0f-99be0addb505", "30e38747-c553-4e2d-bc23-634e1dd90b8d", "595e2f3e-c6d4-4a17-bc06-46512b4275b5", "7c911ac4-db70-44bf-8374-01c8260aa3d4", "f7ed39e2-5431-4e47-935c-c7441d058f94", "2033059b-4be1-42d0-b888-34d8202f3e09", "6bb30cef-c460-4696-8acd-a453408640f4", "73878376-1d24-423b-9f37-3666e83c95da", "c6ca86fb-df23-42c1-9d29-f15312faf60c", "dd5caa3f-3c09-4034-bf43-2df80c61c07b", "9607920c-4d25-40b9-957e-87e9ca5574e8", "ec482425-358c-4500-8f5d-79c1379c1fa8", "8b48d2b3-61b5-4cfc-a8a0-7ccc235dfe5a", "3b36645c-de5e-4263-ae06-2f6ff6a9add2", "e8b86758-6cb5-44ac-a5fc-2111e98a19a8", "532d40b2-c05c-4d4f-b7ee-e6434c4c27fc", "bc8a572d-e0e1-4d37-b3c4-b85415d50393", "dbad7e61-2347-43b1-a422-9183e41c10ea", "dc80228c-acae-44dc-9762-19bd1669bf45", "12f62bae-5fc0-4f8d-a8b4-446524bd53d1", "1ce9c3c5-0cf7-4760-988d-2559adcfb200", "c81343f2-5ef5-4635-9b94-5ac8d72aa61e" ], "package_ndc": [ "62135-068-90", "62135-068-18", "63323-659-09", "70710-1852-6", "70710-1852-7", "70710-1958-6", "70710-1958-7", "68462-406-01", "68462-406-10", "68462-302-01", "68462-302-05", "0054-1950-30", "72603-281-01", "72603-281-30", "69344-101-01", "70771-1766-6", "70771-1766-7", "63323-659-94", "62135-067-90", "62135-067-18", "63323-659-03", "69238-2086-3", "69344-102-33", "70954-637-10", "68462-325-60", "68462-325-90", "68462-325-01", "68462-325-05", "68462-325-10", "72865-148-30", "72865-148-01", "72865-148-05", "72865-148-10", "72865-149-30", "72865-149-01", "72865-149-05", "72865-149-10", "65162-506-03", "65162-506-06", "65162-506-09", "65162-506-10", "65162-506-11", "65162-506-50", "10702-016-03", "10702-016-06", "10702-016-09", "10702-016-01", "10702-016-50", "10702-016-10", "31722-565-30", "31722-565-60", "31722-565-01", "31722-565-05", "31722-565-10", "31722-542-30", "31722-542-01", "31722-542-05", "31722-542-10", "31722-543-30", "31722-543-01", "31722-543-05", "31722-543-10", "31722-051-31" ], "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": [ "XXE1CET956" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140226" } } } ] }