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"4aa3dbef-0e2d-49c7-e063-6294a90a9ba9", "4aa3e0fa-38cd-3f45-e063-6394a90a9a2b", "4aa3f835-f4aa-54bc-e063-6394a90ac250", "04cf0026-e299-ffd5-e063-6294a90aca1f", "d6bfe4ec-21dd-4b6c-8acf-2eda6d409d73", "22094f56-c791-2505-e063-6394a90ad0a4", "0b67e8de-d81d-0fda-e063-6394a90ac229", "21b7a39d-8d50-3f46-e063-6394a90a6404", "4aa443c8-bb31-8f00-e063-6394a90a430d", "22078fec-3885-36f9-e063-6294a90aba17", "a9886a49-ba1d-44f5-96e5-26c927d6db9c", "353453e2-1f60-24ea-e063-6394a90a251e", "474780d5-dd89-8f1a-e063-6294a90a03dc", "17559a44-94b8-9ca0-e063-6294a90a2123" ], "spl_set_id": [ "4139742d-d091-121c-e063-6394a90a6221", "1859a102-9152-018d-e063-6394a90a925f", "38e463d1-f608-7cb5-e063-6294a90a4abb", "413945b5-116b-d8b6-e063-6394a90a55e8", "33da017b-1e8c-d41c-e063-6394a90aab8c", "04cf0026-e29b-ffd5-e063-6294a90aca1f", "cb182e26-17c5-4d00-869f-08823afeeee8", "e4a57710-caa9-51e5-e053-2a95a90a8ad0", "0b67e8de-d81e-0fda-e063-6394a90ac229", "1ab92efb-ae5a-b71c-e063-6294a90a60d1", "93086235-2c33-424d-b0c3-213031988581", "e052d2c2-7a3f-37be-e053-2a95a90af21c", "0a4cb0ab-565f-45e8-a989-740bccef21cd", "353453e2-1f60-24ea-e063-6394a90a251e", "474780d5-dd88-8f1a-e063-6294a90a03dc", "17559a44-94b7-9ca0-e063-6294a90a2123" ], "package_ndc": [ "85477-610-30", "59088-191-54", "85477-904-30", "85477-902-30", "85477-903-30", "59088-795-54", "85477-523-30", "59088-695-54", "59088-158-54", "59088-201-31", "85477-901-30", "59088-643-54", "85477-511-30", "59088-018-54", "85477-623-30", "59088-009-54" ], "nui": [ "N0000193618", "M0001797", "N0000185371", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0022575", "M0016962", "M0022797", "N0000175952", "M0022794", "N0000175951", "N0000175429", "N0000175961", "N0000008867", "N0000175960", "N0000175776", "N0000175547", "N0000175594", "M0014839", "M0022788", "N0000175950" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Vitamin D [EPC]", "Vitamin B12 [EPC]", "Antidote [EPC]", "Antidote for Acetaminophen Overdose [EPC]", "Mucolytic [EPC]", "Nicotinic Acid [EPC]", "Vitamin A [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Allergens [CS]", "Dietary Proteins [CS]", "Vegetable Proteins [CS]", "Plant Proteins [CS]", "Vitamin D [CS]", "Vitamin B 12 [CS]", "Nicotinic Acids [CS]", "Vitamin A [CS]" ], "unii": [ "PQ6CK8PD0R", "935E97BOY8", "BR1SN1JS2W", "25X51I8RD4", "19F5HK2737", "68Y4CF58BV", "TLM2976OFR", "M572600E5P", "KM66971LVF", "V1V998DC17", "A9R10K3F2F", "856YO1Z64F", "WR1WPI7EW8", "01YAE03M7J", "6SO6U10H04", "H0G9379FGK", "1C6V77QF41", "P6YC3EG204", "SFW1D987QV", "3A3U0GI71G", "1C4QK22F9J", "WYQ7N0BPYC", "MLM29U2X85", "RHO26O1T9V", "2679MF687A", "S033EH8359", "8K0I04919X", "81G40H8B0T", "K72I3DEX9B", "568ET80C3D", "LRX7AJ16DT", "R5L488RY0Q", "SK47B8698T", "W00LYS4T26", "89DS0H96TB", "6K2W7T9V6Y", "A150AY412V", "81AH48963U", "H6241UJ22B", "3LE3D9D6OY", "SOI2LOH54Z" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Decreased Respiratory Secretion Viscosity [PE]", "Increased Glutathione Concentration [PE]" ], "pharm_class_moa": [ "Reduction Activity [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LETROZOLE.", "drugstructuredosagenumb": "2.5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2.5 MG, QD", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "drugstartdateformat": "102", "drugstartdate": "20130514", "activesubstance": { "activesubstancename": "LETROZOLE" }, "openfda": { "application_number": [ "ANDA090934", "ANDA091191", "ANDA211717", "ANDA200161", "ANDA090289", "ANDA205869", "NDA020726" ], "brand_name": [ "LETROZOLE", "FEMARA" ], "generic_name": [ "LETROZOLE", "LETROZOLE TABLETS" ], "manufacturer_name": [ "Accord Healthcare, Inc.", "Dr. Reddy's Laboratories Limited", "Aurobindo Pharma Limited", "Natco Pharma Limited", "Teva Pharmaceuticals USA, Inc.", "Chartwell RX, LLC", "Breckenridge Pharmaceutical, Inc.", "Novartis Pharmaceuticals Corporation", "Avet Pharmaceuticals Inc.", "Yiling Pharmaceutical, Inc.", "Upsher-Smith Laboratories, LLC" ], "product_ndc": [ "16729-034", "55111-646", "59651-180", "63850-0025", "0093-7620", "62135-491", "51991-759", "0078-0249", "23155-875", "69117-0004", "24979-726" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LETROZOLE" ], "rxcui": [ "200064", "153124" ], "spl_id": [ "4a681bf4-9779-a1b2-e063-6294a90a83db", "ec1b249b-2d77-55d9-0520-23884a961cf0", "2cd5dbfd-2432-4cea-bee2-6b710b5d28a2", "7917d6e0-df93-4c10-97c9-3d90b00b7bd4", "c91fb703-e253-490e-bb1d-48d054d81c6e", "456ed484-059b-2ee9-e063-6294a90a3f83", "35b275df-f687-4e29-828b-637d5377cc73", "f052c25a-d848-4b2d-8ff3-73bee0c89ad7", "40009527-770b-8999-e063-6294a90a9946", "4721d1b1-3a04-27fb-e063-6394a90a7c1a", "4d5cb59c-11c3-4b0d-e063-6294a90a5b87" ], "spl_set_id": [ "c391fe11-fd47-4a35-af6d-c823ab7b8838", "6cfd29d7-f519-7b8c-4814-07b39f367f0d", "ff7325d2-3383-4ff9-a187-9350e3538640", "35c73219-c39e-4e10-b944-76009b061e79", "8ebda73d-82a3-4b17-8a81-a1f258003d32", "fa2d40a5-3504-44ef-8f5c-aa4c06308074", "63e54b62-a30d-4a56-9215-75e7a0b0bf02", "82b77d74-085f-45ac-a7dd-1f5c038bf406", "fe0e4d4b-436d-a36d-e053-6294a90a973d", "7b00e08c-9a1c-09e0-e053-2a91aa0a7638", "2d1f18f0-2c77-407c-b702-2d1b07f92510" ], "package_ndc": [ "16729-034-10", "16729-034-15", "16729-034-01", "16729-034-16", "16729-034-17", "16729-034-43", "55111-646-30", "55111-646-79", "55111-646-78", "59651-180-30", "59651-180-90", "63850-0025-1", "63850-0025-4", "0093-7620-56", "62135-491-30", "62135-491-90", "51991-759-33", "51991-759-10", "51991-759-90", "0078-0249-15", "23155-875-03", "23155-875-09", "23155-875-10", "69117-0004-1", "24979-726-07" ], "nui": [ "N0000175563", "N0000175080" ], "pharm_class_epc": [ "Aromatase Inhibitor [EPC]" ], "pharm_class_moa": [ "Aromatase Inhibitors [MoA]" ], "unii": [ "7LKK855W8I" ] } }, { "drugcharacterization": "1", "medicinalproduct": "XGEVA", "drugauthorizationnumb": "125320", "drugstructuredosagenumb": "120", "drugstructuredosageunit": "003", "drugcumulativedosagenumb": "1680", "drugcumulativedosageunit": "003", "drugdosagetext": "120 MG, Q4WK", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "058", "drugindication": "BREAST CANCER METASTATIC", "drugstartdateformat": "102", "drugstartdate": "20130205", "drugenddateformat": "102", "drugenddate": "20140220", "actiondrug": "1", "activesubstance": { "activesubstancename": "DENOSUMAB" }, "openfda": { "application_number": [ "BLA125320" ], "brand_name": [ "XGEVA" ], "generic_name": [ "DENOSUMAB" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "DENOSUMAB" ], "rxcui": [ "1046398", "1046402" ], "spl_id": [ "a554622d-cdd7-4ab6-b581-a43fb6fbab45" ], "spl_set_id": [ "628f0998-1206-4001-aeee-18133aa9f3bf" ], "package_ndc": [ "55513-730-01", "55513-730-21" ], "nui": [ "N0000187055", "N0000187054" ], "pharm_class_epc": [ "RANK Ligand Inhibitor [EPC]" ], "pharm_class_moa": [ "RANK Ligand Blocking Activity [MoA]" ], "unii": [ "4EQZ6YO2HI" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140404" } } } ] }