{ "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": 47364 } }, "results": [ { "safetyreportversion": "9", "safetyreportid": "10003554", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20160304", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20151030", "fulfillexpeditecriteria": "1", "companynumb": "PHFR2014GB002024", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHFR2014GB002024" }, "primarysource": { "reportercountry": "GB", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "38", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Monocyte count decreased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Gamma-glutamyltransferase increased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "B-lymphocyte count decreased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Skin lesion", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Mean platelet volume decreased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Kaposi^s sarcoma", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "White blood cell count decreased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Lymphocyte count decreased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "Neutrophil count decreased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.1", "reactionmeddrapt": "T-lymphocyte count decreased", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "BACLOFEN.", "drugadministrationroute": "065", "drugindication": "MUSCLE SPASMS", "actiondrug": "5", "activesubstance": { "activesubstancename": "BACLOFEN" }, "openfda": { "application_number": [ "ANDA078401", "NDA208193", "ANDA214099", "ANDA217687", "ANDA212378", "ANDA215885", "NDA215422", "NDA020075", "ANDA209102", "ANDA217324", "ANDA217252", "ANDA214445", "NDA215602", "ANDA074584", "ANDA210048", "ANDA072234", "ANDA072235", "ANDA214374", "ANDA210315", "ANDA077241", "ANDA211555", "ANDA078220", "ANDA210777", "ANDA077068", "ANDA211659", "ANDA212067" ], "brand_name": [ "BACLOFEN", "LYVISPAH", "LIORESAL (BACLOFEN)", "BACLOFEN (INTRATHECAL)", "OZOBAX DS", "FLEQSUVY" ], "generic_name": [ "BACLOFEN" ], "manufacturer_name": [ "Northstar RxLLC", "Palmetto Pharmaceuticals Inc.", "Medcore LLC", "Micro Labs Limited", "Method Pharmaceuticals LLC", "Major Pharmaceuticals", "Amneal Pharmaceuticals LLC", "TruPharma LLC", "Nexus Pharmaceuticals LLC", "Slayback Pharma LLC", "Advagen Pharma Ltd", "Wilshire Pharmaceuticals, Inc.", "Lifestar Pharma LLC", "Advagen Pharma Ltd.,", "Upsher-Smith Laboratories, LLC", "Advagen Pharma Limited", "MAIA Pharmaceuticals, Inc.", "Aurobindo Pharma Limited", "Rosemont Pharmaceuticals LLC", "Teva Pharmaceuticals USA, Inc.", "TRUPHARMA, LLC", "Rising Pharma Holdings, Inc.", "Sagent Pharmaceuticals", "Chartwell RX, LLC", "Eywa Pharma Inc", "Lannett Company, Inc.", "MAlA Pharmaceuticals, Inc.", "Trifluent Pharma, LLC", "Par Health USA, LLC", "Zydus Pharmaceuticals (USA) Inc.", "Marlex Pharmaceuticals Inc", "XLCare Pharmaceuticals Inc.", "Azurity Pharmaceuticals, Inc.", "Zydus Lifesciences Limited", "SOLA Pharmaceuticals, LLC", "Unichem Pharmaceuticals (USA), Inc.", "ANI Pharmaceuticals, Inc." ], "product_ndc": [ "16714-071", "16714-072", "68134-403", "82461-717", "82461-718", "42571-427", "42571-428", "42571-429", "58657-730", "58657-932", "58657-731", "58657-732", "58657-931", "58657-930", "0904-7552", "0904-7553", "64896-076", "64896-077", "64896-078", "70121-2496", "70121-2501", "70121-2502", "70121-2504", "70121-2503", "70121-2505", "52817-318", "52817-319", "52817-320", "52817-321", "14789-161", "71225-140", "72888-103", "52536-600", "70756-085", "70756-288", "70756-289", "72888-466", "0832-1054", "0832-1055", "72888-009", "72888-010", "72888-202", "72888-011", "70511-122", "70511-124", "59651-394", "59651-395", "72834-602", "0172-4096", "0172-4097", "52817-620", "69528-302", "16571-169", "16571-171", "16571-172", "25021-680", "25021-678", "25021-679", "62135-472", "62135-473", "62135-474", "71930-006", "71930-066", "71930-007", "0527-1330", "0527-1337", "0527-1333", "70511-121", "73352-103", "0603-2406", "0603-2407", "70511-123", "70710-1285", "70710-1286", "70710-1609", "70710-1666", "10135-532", "10135-533", "72865-296", "72865-297", "72865-298", "52652-6001", "70771-1448", "70771-1449", "70771-1586", "70771-1868", "25021-681", "70512-782", "29300-343", "29300-474", "29300-344", "72888-145", "72888-146", "72888-147", "62559-204", "84386-035" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRATHECAL" ], "substance_name": [ "BACLOFEN" ], "rxcui": [ "197391", "197392", "2667941", "430902", "2586589", "2586595", "2586596", "2586598", "2586599", "2586601", "308516", "308517", "805678", "805679", "1666613", "1666620", "1666622", "1666623", "2679605", "2593376", "250976", "2667943", "1300890", "1047437", "2593382" ], "spl_id": [ "a3881489-a033-4a93-ba24-590e316103f3", "47426f2f-4630-5a83-e063-6294a90a88d1", "152e2f4d-157b-4dad-8d18-ab3f63792051", "0acb9150-3e4c-9f37-e063-6294a90a7fd6", "3aa113f3-27d5-328b-e063-6394a90af9e5", "5c3857ec-f6de-489c-909d-79cad21f784e", "d042d45f-7097-47e0-921f-0442e00d47e0", "d68a08e0-d0d9-4144-be01-47b636dfa7e1", "1645f54e-2eed-bd9b-e063-6294a90a848b", "2ac0f53e-48b5-5d84-e063-6294a90a8ac8", "f948e217-c9bb-4ec1-b5fb-864cc14afe4e", "3760a935-7c14-5771-e063-6394a90a1fb0", "461e14b2-890c-011c-e063-6294a90a0d4c", "97901dd3-f1e0-4fc8-86a1-5114e2095073", "374c7fbe-ca7e-09b4-e063-6394a90ab5fa", "45af8926-ad18-a93a-e063-6294a90a1dca", "490e18d8-694e-da7b-e063-6294a90ab450", "c15b60c7-4e21-4e28-898c-31e23052737a", "493c1b1f-7ee0-4a54-8e44-b2b015eb3850", "544cca2f-c73f-8fcc-e063-6394a90a67fb", "ba227be6-e946-423c-a9a6-e0626d889ea7", "0806a6f9-b626-f98e-e063-6294a90a84bb", "4ce95252-8c9b-2246-e063-6294a90a8b25", "ff66a259-5803-47a3-9558-87acf43f43a7", "81266703-bafa-4e31-a400-32fbfe1a849e", "9ae563da-240a-468d-bc42-ed4667df2392", "24246dff-9253-1075-e063-6394a90a75c0", "ff342eff-68ae-4190-96bb-f887fff1dd56", "153f6bd7-9462-4d92-b738-48e7807c5919", "58150ebf-c2d6-49be-a519-06d839637462", "3a73197c-59cf-621b-e063-6394a90a955b", "25fe173e-f3ce-4d70-adec-7e23e455679a", "c25028b0-ac87-4b40-b8e4-fef625b32ccb", "f96d29a2-071a-4a33-a57e-bb55eba0d660", "3f668f68-659e-2740-e063-6394a90a6264", "2d6876fe-19e5-fd4f-e063-6294a90a7960", "461e773b-ccc2-532d-e063-6294a90abad9", "2c2eb58e-8920-43f4-aaa9-6f5add3b35ae", "570e9773-fda9-492f-bdef-7dd6814fd3b2", "45723949-ac04-69ef-e063-6294a90a29a3", "513de439-4155-4a5d-a25c-bced499e293a", "45801dc3-fb9b-c31e-e063-6294a90aff35", "1c95cf7d-6db8-437d-9e33-f8ecb151eca6", "f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a" ], "spl_set_id": [ "0aac77fa-30c2-46c8-a04d-e6b8333ddd81", "2422746c-afec-ad30-e063-6394a90a0403", "13eca70c-3cc8-4317-83cf-ade3327e48c0", "f0abf768-3b19-452b-b56d-eb70441cfb18", "1a9db542-d2b0-141a-e063-6394a90acc11", "f328296e-0713-4acb-bcb5-c10d7838d380", "f8992a56-9010-4c4b-84d5-ddcc3e2c3317", "6f3bdcc0-ffc8-4911-8c35-958c8103a2c5", "68aa591e-ea98-4438-9a4a-4f7e9ea2b285", "68c9ade0-d783-43e9-8a3f-a16ec1501ec1", "9fad5ffc-afae-4c92-a672-ee636df45bc5", "2a43830f-a28b-ca15-e063-6294a90a6b1a", "4585aafe-0af8-4786-a419-6a7e76671ca2", "f9dd1b55-2984-446a-8146-2ab0f5211e15", "75ab298b-b2a7-458f-accc-5bfc89b89a16", "b2747a9d-5fca-4657-9e4b-4112607f30d8", "04dac0f6-cc6c-4959-9bca-a6e4a99690f3", "11ba5575-a856-414a-89f8-17f3a01de55b", "4679a275-9307-4b0f-a2eb-2d83227ea84d", "81a539b3-e547-4a62-ad1b-2eedb30be927", "5648c772-50cb-4961-996e-e68a8eb699ea", "f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7", "d8ddcec5-debe-42b4-a803-e65917cc6a54", "6eb46715-d72b-473f-b984-90024033d4a0", "d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51", "077aaf3b-1ca3-4599-a51a-6bbe39810ca8", "2a75db96-590a-43cf-aefb-3bbcb287dbf0", "7ec59f6b-7c4f-432d-ba27-442861806b6c", "f84f3f4c-17e6-43f1-9600-63b0b175837b", "e05080ef-53d9-4060-aaa4-86a6935467de", "890df151-f4eb-4244-97c4-f1f10912e753", "c17527be-661d-42f5-b6f6-56a681ba7870", "dfa6148c-693c-45f1-89be-0e77d39f313e", "cfc49176-8d01-4c39-9319-604dd087065c", "1b0f50c8-62e3-414d-96d3-5fd16e8043ab", "2b4908fb-47b5-4675-be9e-ca1ad48a7252", "9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa", "bb5c6faa-2933-44d1-8706-8302150be734", "ea32c39c-0ee3-4b5e-8da7-4c31db334bd8", "7b308b35-8c08-458d-860e-c78d057e8260", "b9199878-3fb4-46dc-adbb-b3d9dc3852d4", "d63af5f0-c275-480b-89b5-6cf1ad55ab63", "c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0", "f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a" ], "package_ndc": [ "16714-071-04", "16714-071-06", "16714-072-04", "16714-072-05", "68134-403-16", "82461-717-10", "82461-718-10", "42571-427-01", "42571-428-01", "42571-428-05", "42571-428-13", "42571-429-01", "42571-429-05", "42571-429-13", "58657-932-10", "58657-932-05", "58657-932-01", "58657-730-01", "58657-730-10", "58657-731-01", "58657-731-10", "58657-731-50", "58657-732-01", "58657-732-50", "58657-732-10", "58657-931-10", "58657-931-05", "58657-931-01", "58657-930-10", "58657-930-05", "58657-930-01", "0904-7552-61", "0904-7553-61", "64896-076-09", "64896-077-09", "64896-078-09", "70121-2501-1", "70121-2502-2", "70121-2504-2", "70121-2503-1", "70121-2505-2", "70121-2496-5", "52817-319-10", "52817-320-10", "52817-320-50", "52817-320-00", "52817-318-10", "52817-321-10", "52817-321-50", "52817-321-00", "14789-161-05", "71225-140-01", "72888-103-24", "52536-600-11", "52536-600-12", "70756-085-11", "70756-288-11", "70756-288-12", "70756-288-01", "70756-288-99", "70756-289-11", "70756-289-51", "70756-289-12", "70756-289-01", "70756-289-99", "72888-466-02", "72888-466-01", "0832-1054-90", "0832-1054-11", "0832-1054-15", "0832-1054-10", "0832-1055-90", "0832-1055-11", "0832-1055-15", "0832-1055-10", "72888-009-01", "72888-009-05", "72888-010-01", "72888-010-05", "72888-010-00", "72888-202-30", "72888-202-01", "72888-202-05", "72888-202-00", "72888-011-01", "72888-011-05", "72888-011-00", "70511-122-10", "70511-124-10", "59651-394-01", "59651-394-05", "59651-394-99", "59651-395-01", "59651-395-05", "59651-395-99", "72834-602-16", "0172-4096-60", "0172-4096-80", "0172-4097-60", "0172-4097-80", "52817-620-08", "69528-302-08", "69528-302-16", "16571-169-01", "16571-171-01", "16571-171-50", "16571-171-10", "16571-172-01", "16571-172-50", "16571-172-10", "25021-680-20", "25021-678-20", "25021-679-20", "62135-472-90", "62135-473-90", "62135-473-05", "62135-474-90", "62135-474-05", "71930-066-12", "71930-066-52", "71930-066-13", "71930-006-12", "71930-006-52", "71930-006-13", "71930-007-12", "71930-007-52", "71930-007-13", "0527-1330-01", "0527-1330-05", "0527-1330-10", "0527-1337-01", "0527-1337-05", "0527-1337-10", "0527-1333-01", "70511-121-06", "70511-121-83", "70511-121-80", "73352-103-16", "0603-2406-02", "0603-2406-21", "0603-2406-28", "0603-2406-32", "0603-2406-30", "0603-2407-21", "0603-2407-28", "0603-2407-32", "70511-123-20", "70710-1285-1", "70710-1285-5", "70710-1285-0", "70710-1286-1", "70710-1286-5", "70710-1286-0", "70710-1609-1", "70710-1666-1", "10135-532-01", "10135-532-05", "10135-532-10", "10135-533-01", "10135-533-05", "10135-533-10", "72865-296-01", "72865-297-01", "72865-297-05", "72865-297-10", "72865-298-01", "72865-298-05", "72865-298-10", "52652-6001-1", "52652-6001-2", "70771-1448-1", "70771-1448-5", "70771-1448-0", "70771-1449-1", "70771-1449-5", "70771-1449-0", "70771-1586-1", "70771-1868-1", "25021-681-71", "70512-782-10", "29300-474-01", "29300-343-19", "29300-343-01", "29300-343-05", "29300-343-10", "29300-344-19", "29300-344-01", "29300-344-05", "29300-344-10", "72888-145-36", "72888-146-36", "72888-147-36", "62559-204-12", "62559-204-03", "84386-035-01" ], "nui": [ "N0000000196", "N0000000116", "N0000175759" ], "pharm_class_moa": [ "GABA A Agonists [MoA]", "GABA B Agonists [MoA]" ], "pharm_class_epc": [ "gamma-Aminobutyric Acid-ergic Agonist [EPC]" ], "unii": [ "H789N3FKE8" ] } }, { "drugcharacterization": "1", "medicinalproduct": "GILENYA", "drugauthorizationnumb": "022527", "drugstructuredosagenumb": ".5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugcumulativedosagenumb": "214", "drugcumulativedosageunit": "003", "drugdosagetext": "0.5 MG, QD", "drugadministrationroute": "048", "drugindication": "RELAPSING-REMITTING MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20121030", "drugenddateformat": "102", "drugenddate": "20140303", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "FINGOLIMOD HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA022527" ], "brand_name": [ "GILENYA" ], "generic_name": [ "FINGOLIMOD HCL" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0607", "0078-0965" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FINGOLIMOD HYDROCHLORIDE" ], "rxcui": [ "1012895", "1012899", "2045491", "2045493" ], "spl_id": [ "160c27a2-4788-441a-ac42-674e5aec433b" ], "spl_set_id": [ "cc9e1c8c-0e2b-44e2-878b-27057f786be9" ], "package_ndc": [ "0078-0607-15", "0078-0607-51", "0078-0607-89", "0078-0965-89" ], "unii": [ "G926EC510T" ] } }, { "drugcharacterization": "2", "medicinalproduct": "INTERFERON BETA-1A", "drugadministrationroute": "065", "drugindication": "MUSCLE SPASMS", "actiondrug": "5", "activesubstance": { "activesubstancename": "INTERFERON BETA-1A" }, "openfda": { "application_number": [ "BLA103780", "BLA103628" ], "brand_name": [ "REBIF", "REBIF REBIDOSE", "AVONEX", "AVONEX PEN" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc.", "Biogen Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344", "59627-002", "59627-333", "59627-222", "59627-003" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAMUSCULAR" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282", "727813", "727816", "797544", "1650899", "1650901" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6", "8c84155d-4436-404a-bb05-aee683889f0b" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f", "d70a39cc-de15-4c12-a1ec-8063b69ea0e1" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1", "59627-333-04", "59627-222-05", "59627-003-01", "59627-002-07", "59627-002-06" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 201401" } } }, { "safetyreportversion": "1", "safetyreportid": "10003589", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "US-US-EMD SERONO, INC.-7274353", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "US-US-EMD SERONO, INC.-7274353" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "63", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Loss of consciousness", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fall", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Convulsion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Influenza", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Speech disorder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Malaise", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugbatchnumb": "AU008268", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "44", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosageform": "INJECTION", "drugadministrationroute": "058", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20130902", "actiondrug": "5", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZOLOFT /01011401/", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "COMPAZINE /00013302/", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "OXYCODONE", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA203638", "NDA208090" ], "brand_name": [ "OXYCODONE HYDROCHLORIDE", "XTAMPZA ER" ], "generic_name": [ "OXYCODONE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Collegium Pharmaceutical, Inc." ], "product_ndc": [ "65162-047", "65162-048", "65162-049", "65162-050", "65162-051", "24510-110", "24510-115", "24510-120", "24510-130", "24510-140" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OXYCODONE HYDROCHLORIDE", "OXYCODONE" ], "rxcui": [ "1049611", "1049618", "1049621", "1049683", "1049686", "1790527", "1790533", "1791558", "1791560", "1791567", "1791569", "1791574", "1791576", "1791580", "1791582" ], "spl_id": [ "4fb6c994-cbd3-4d0d-bdae-505cb8082e61", "fda0989d-9319-4e35-af83-fca1ec66878e" ], "spl_set_id": [ "094b64b3-cd32-4de5-afb6-ea00d9caad74", "b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c" ], "package_ndc": [ "65162-047-03", "65162-047-10", "65162-047-25", "65162-047-50", "65162-048-03", "65162-048-10", "65162-048-25", "65162-049-03", "65162-049-10", "65162-049-25", "65162-049-50", "65162-050-03", "65162-050-10", "65162-050-25", "65162-051-03", "65162-051-10", "65162-051-25", "65162-051-50", "24510-110-10", "24510-110-20", "24510-115-10", "24510-115-20", "24510-120-10", "24510-120-20", "24510-130-10", "24510-130-20", "24510-140-10", "24510-140-20" ], "unii": [ "C1ENJ2TE6C", "CD35PMG570" ], "nui": [ "N0000175684", "N0000175690" ], "pharm_class_moa": [ "Full Opioid Agonists [MoA]" ], "pharm_class_epc": [ "Opioid Agonist [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HYDROCODONE", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "ABILIFY", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA021436" ], "brand_name": [ "ABILIFY" ], "generic_name": [ "ARIPIPRAZOLE" ], "manufacturer_name": [ "Otsuka America Pharmaceutical, Inc." ], "product_ndc": [ "59148-006", "59148-007", "59148-008", "59148-009", "59148-010", "59148-011" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ARIPIPRAZOLE" ], "rxcui": [ "349490", "349545", "349547", "349553", "352307", "352308", "352309", "352310", "402131", "404602", "602964", "615172" ], "spl_id": [ "1b189d15-798d-4bed-a93d-a543ed7abd81" ], "spl_set_id": [ "c040bd1d-45b7-49f2-93ea-aed7220b30ac" ], "package_ndc": [ "59148-006-13", "59148-006-92", "59148-007-13", "59148-007-35", "59148-007-94", "59148-008-13", "59148-008-35", "59148-008-95", "59148-009-13", "59148-009-35", "59148-009-95", "59148-010-13", "59148-010-35", "59148-011-13", "59148-011-35" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "82VFR53I78" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10003707", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "US-US-EMD SERONO, INC.-7269785", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "US-US-EMD SERONO, INC.-7269785" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "41", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Suicide attempt", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Antipsychotic drug level below therapeutic", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Mental disorder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Antipsychotic drug level above therapeutic", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Adverse reaction", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Suicidal ideation", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dizziness", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Aphasia", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Syncope", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Memory impairment", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Bronchitis", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Irritability", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Feeling abnormal", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Amnesia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Conversion disorder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Visual impairment", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vision blurred", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Headache", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pyrexia", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pain", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Injection site reaction", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Injection site haemorrhage", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fatigue", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "22", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosageform": "INJECTION", "drugadministrationroute": "058", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20140108", "actiondrug": "5", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "44", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosageform": "INJECTION", "drugadministrationroute": "058", "drugenddateformat": "102", "drugenddate": "20140221", "actiondrug": "5", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "WELLBUTRIN", "drugindication": "BIPOLAR DISORDER", "openfda": { "application_number": [ "NDA021515", "NDA020358" ], "brand_name": [ "WELLBUTRIN XL", "WELLBUTRIN SR" ], "generic_name": [ "BUPROPION HYDROCHLORIDE" ], "manufacturer_name": [ "Bausch Health US LLC", "GlaxoSmithKline LLC" ], "product_ndc": [ "0187-0730", "0187-0731", "0173-0135", "0173-0947", "0173-0722" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BUPROPION HYDROCHLORIDE" ], "rxcui": [ "993541", "993545", "993557", "993564", "993503", "993511", "993518", "993528", "993536", "993537" ], "spl_id": [ "22308f71-fc56-430d-b559-bed47e17a46c", "5ffc8b63-7d69-4f3a-bf05-a9c138724a91" ], "spl_set_id": [ "a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "cbc8c074-f080-4489-a5ae-207b5fadeba3" ], "package_ndc": [ "0187-0730-30", "0187-0730-90", "0187-0730-07", "0187-0731-30", "0187-0731-07", "0173-0947-55", "0173-0135-55", "0173-0722-00" ], "unii": [ "ZG7E5POY8O" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LITHIUM", "drugindication": "BIPOLAR DISORDER", "drugstartdateformat": "602", "drugstartdate": "1989", "openfda": { "application_number": [ "ANDA218036", "ANDA217183", "ANDA070755" ], "brand_name": [ "LITHIUM" ], "generic_name": [ "LITHIUM", "LITHIUM BROMATUM" ], "manufacturer_name": [ "Advagen Pharma Ltd", "Saptalis Pharmaceuticals, LLC", "PAI Holdings, LLC dba PAI Pharma", "Marco Pharma International LLC." ], "product_ndc": [ "72888-172", "71656-072", "0121-1027", "0121-4027", "60986-1019" ], "product_type": [ "HUMAN PRESCRIPTION DRUG", "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LITHIUM CITRATE", "LITHIUM BROMIDE" ], "rxcui": [ "756059" ], "spl_id": [ "47c8d276-05d5-8641-e063-6294a90a8bbc", "3ccc30e9-1f5d-5715-e063-6394a90a6bc1", "0a44f05f-6cf7-4264-a228-1372bf0e9154", "483c1e49-a5da-749f-e063-6394a90a226e" ], "spl_set_id": [ "ff9baf45-830f-4a8a-8986-5caeaa1b38cf", "e95036c7-542a-437a-969b-f95f6f949f84", "677b20c4-84f0-4716-aca3-aead3bbe1283", "f4a1d451-33ad-4df3-ae68-58cfbfccfa89" ], "package_ndc": [ "72888-172-46", "71656-072-16", "71656-072-05", "71656-072-50", "0121-1027-16", "0121-4027-05", "0121-4027-94", "60986-1019-3", "60986-1019-4" ], "unii": [ "5Z6E9K79YV", "864G646I84" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATIVAN", "drugindication": "BIPOLAR DISORDER", "openfda": { "application_number": [ "NDA017794", "NDA018140" ], "brand_name": [ "ATIVAN" ], "generic_name": [ "LORAZEPAM" ], "manufacturer_name": [ "Bausch Health US LLC", "Hikma Pharmaceuticals USA Inc." ], "product_ndc": [ "0187-0063", "0187-0064", "0187-0065", "0641-6000", "0641-6003", "0641-6002", "0641-6001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "LORAZEPAM" ], "rxcui": [ "104719", "197900", "197901", "197902", "206821", "206828", "206819", "206820", "238100", "238101", "1665188", "1665190", "1665326", "1665327" ], "spl_id": [ "93bdf2de-1222-44a4-b4d5-2280f9ce58d8", "209b0091-c890-4f69-a693-d0594c2606fe" ], "spl_set_id": [ "89057c93-8155-4040-acec-64e877bd2b4c", "5fc0e987-61c9-40c4-b0d5-fcea07c8733e" ], "package_ndc": [ "0187-0063-01", "0187-0063-50", "0187-0063-10", "0187-0064-01", "0187-0064-50", "0187-0064-10", "0187-0065-01", "0187-0065-50", "0187-0065-10", "0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "O26FZP769L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NEURONTIN", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA020235", "NDA021129", "NDA020882" ], "brand_name": [ "NEURONTIN" ], "generic_name": [ "GABAPENTIN" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc", "Viatris Specialty LLC" ], "product_ndc": [ "0071-0805", "0071-0803", "0071-0806", "0071-0513", "0071-0401", "0071-2012", "58151-281", "58151-282", "58151-283", "58151-284", "58151-285", "58151-290" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "GABAPENTIN" ], "rxcui": [ "105028", "105029", "105030", "261280", "261281", "283523", "310430", "310431", "310432", "310433", "310434", "351973" ], "spl_id": [ "e730d5df-d47b-4d7f-ae3b-bd449f6b1213", "dfbc1443-0ba8-479b-8590-32bd942732d4" ], "spl_set_id": [ "ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388", "97935fd9-1d4a-43b6-a5d9-de994591187b" ], "package_ndc": [ "0071-0803-24", "0071-0803-40", "0071-0805-24", "0071-0805-40", "0071-0806-24", "0071-0806-40", "0071-0513-24", "0071-0401-24", "0071-2012-23", "0071-2012-44", "0071-2012-47", "58151-281-01", "58151-282-01", "58151-283-01", "58151-284-01", "58151-285-01", "58151-290-35" ], "nui": [ "N0000008486" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "unii": [ "6CW7F3G59X" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10003952", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "US-US-EMD SERONO, INC.-7274972", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "US-US-EMD SERONO, INC.-7274972" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "50", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Endometriosis", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Uterine leiomyoma", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Type 2 diabetes mellitus", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Central nervous system lesion", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Injection site pain", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Injection site bruising", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Wrong technique in drug usage process", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugbatchnumb": "AU008268", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "44", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosageform": "INJECTION", "drugadministrationroute": "058", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20070228", "actiondrug": "4", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10004089", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "3", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "US-ACORDA-ACO_100094_2013", "duplicate": "1", "reportduplicate": { "duplicatesource": "ACORDA", "duplicatenumb": "US-ACORDA-ACO_100094_2013" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "46", "patientonsetageunit": "801", "patientweight": "122.45", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Convulsion", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Alcohol detoxification", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Loss of consciousness", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Alcohol withdrawal syndrome", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Renal failure acute", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dehydration", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Joint injury", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Tongue injury", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Swollen tongue", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Electrolyte imbalance", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dysarthria", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fall", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Laceration", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Headache", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "AMPYRA", "drugauthorizationnumb": "022250", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, Q 12 HRS", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "GAIT DISTURBANCE", "drugstartdateformat": "610", "drugstartdate": "201004", "drugenddateformat": "102", "drugenddate": "20110307", "actiondrug": "1", "openfda": { "application_number": [ "NDA022250" ], "brand_name": [ "AMPYRA" ], "generic_name": [ "DALFAMPRIDINE" ], "manufacturer_name": [ "Merz Pharmaceuticals, LLC" ], "product_ndc": [ "0259-5010", "10144-427" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DALFAMPRIDINE" ], "rxcui": [ "897021", "897025" ], "spl_id": [ "b0f65c2b-ee14-421f-9f24-178e108e38cf", "dda9045d-2f23-412c-9543-74832f421739" ], "spl_set_id": [ "974fb2af-7012-4989-b330-e44a31c9c3e5", "550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783" ], "package_ndc": [ "0259-5010-60", "10144-427-60" ], "nui": [ "N0000192795", "N0000175448" ], "pharm_class_epc": [ "Potassium Channel Blocker [EPC]" ], "pharm_class_moa": [ "Potassium Channel Antagonists [MoA]" ], "unii": [ "BH3B64OKL9" ] } }, { "drugcharacterization": "1", "medicinalproduct": "BUSPAR", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 UNK, TID", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3" }, { "drugcharacterization": "2", "medicinalproduct": "GLUCOPHAGE", "drugdosagetext": "UNK,UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3" }, { "drugcharacterization": "2", "medicinalproduct": "LIPITOR", "drugdosagetext": "UNK,UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SPIRONOLACTONE", "drugdosagetext": "UNK,UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA091426", "ANDA040750", "ANDA203253", "ANDA203512", "NDA209478", "ANDA219494", "ANDA202187", "ANDA218085", "ANDA215572", "ANDA205936", "ANDA217761", "NDA012151", "ANDA089424", "ANDA040424" ], "brand_name": [ "SPIRONOLACTONE", "ALDACTONE" ], "generic_name": [ "SPIRONOLACTONE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Oxford Pharmaceuticals, LLC", "Jubilant Cadista Pharmacuticals Inc.", "Accord Healthcare, Inc.", "Amneal Pharmaceuticals of New York LLC", "Padagis US LLC", "Rising Pharma Holdings, Inc.", "NorthStar Rx LLC", "Aurobindo Pharma Limited", "Camber Pharmaceuticals, Inc.", "Amneal Pharmaceuticals NY LLC", "Zydus Lifesciences Limited", "Pfizer Laboratories Div Pfizer Inc", "Zydus Pharmaceuticals (USA) Inc.", "Sun Pharmaceutical Industries, Inc.", "Mylan Pharmaceuticals Inc." ], "product_ndc": [ "65162-511", "65162-514", "65162-515", "69584-852", "69584-853", "69584-854", "59746-216", "59746-217", "59746-218", "16729-225", "16729-226", "16729-227", "53746-511", "53746-514", "53746-515", "0574-1133", "64980-706", "64980-707", "64980-708", "72603-134", "72603-135", "72603-136", "59651-426", "59651-427", "59651-428", "31722-691", "69238-2027", "70771-1027", "70771-1028", "70771-1029", "31722-094", "31722-095", "31722-096", "0025-1001", "0025-1041", "0025-1031", "68382-660", "68382-661", "68382-662", "53489-143", "53489-328", "53489-329", "0378-0243", "0378-2146", "0378-0437" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SPIRONOLACTONE" ], "rxcui": [ "198222", "198223", "313096", "104232", "200817", "200820", "200825" ], "spl_id": [ "8cdb3181-3666-48aa-a197-fb3a1e082e74", "70be7336-8f41-4960-b57d-7830ca020481", "c1c5fdab-3ff7-414b-8e25-beed8311b8ad", "44e7bdd1-ae77-4b63-e063-6294a90a2c28", "0b757d66-e1f0-4d56-bbe0-2f0941f0a35e", "902035fb-dba8-4fdf-9d8d-29d736c07d57", "1db052c9-3239-4b01-977e-99e9c58962f2", "7839b797-5078-4aab-93a5-6056e4b9cdd5", "04da3e98-02e5-4d5a-94b2-9a6f74c44f15", "9b6802a0-5117-4be3-a113-9098e8dcedaa", "3241a29b-82b9-fd3a-e063-6294a90aa46c", "e25b36dd-7948-4481-8994-13658f1f337f", "038310cc-d190-4868-9442-00f7222d0597", "55b4deef-e478-6648-e063-6294a90ae730", "22946678-dcad-4518-9bc6-cbdf51a38c16", "79b8df9c-5a73-432e-bd16-bbbecd9e2046", "535807c8-6443-1ed9-e063-6394a90ac735", "b78b6da0-ce99-4c8f-bf36-c4e19b34dfd9" ], "spl_set_id": [ "fb66327e-8261-46ae-b39a-4fa79d520844", "852684dc-e1c6-4caa-bccb-10ac90bbb3bb", "c1c5fdab-3ff7-414b-8e25-beed8311b8ad", "8a96e2c9-049a-43ab-abf3-21baedeb736f", "951b8948-dc0f-4aef-9910-82c252de936d", "522bd365-ddcc-48f4-8a98-66dc4c3bb314", "ac487ae2-e15f-4781-bae3-a03058cfcfe4", "a7510768-8a52-4230-6aa0-b0d92d82588f", "ae0dcb4e-63df-459c-8e60-0caa817b8135", "768563dc-a619-44dc-b97f-1a7e71fd56a0", "4ac2926a-949a-4383-b0b0-92c0822dfcda", "1ed9a2cb-d666-43db-b515-f9615fa6da25", "963af399-feb7-49d2-a59c-c19edad9c682", "e61269b2-823a-49e8-b55f-ef0b8b1dbcde", "0fed2822-3a03-4b64-9857-c682fcd462bc", "99bbc053-0e41-4b4d-979a-db610908f2de", "c23b6b9b-aec3-48a8-a518-76e4097f6479", "beaf74db-4159-3b59-ef99-575c3ac99aa1" ], "package_ndc": [ "65162-511-03", "65162-511-06", "65162-511-09", "65162-511-10", "65162-511-11", "65162-511-50", "65162-511-60", "65162-514-03", "65162-514-06", "65162-514-09", "65162-514-10", "65162-514-11", "65162-514-50", "65162-514-60", "65162-515-03", "65162-515-06", "65162-515-09", "65162-515-10", "65162-515-11", "65162-515-50", "65162-515-60", "69584-852-09", "69584-852-10", "69584-852-50", "69584-852-90", "69584-852-92", "69584-853-09", "69584-853-10", "69584-853-50", "69584-853-90", "69584-854-09", "69584-854-10", "69584-854-50", "69584-854-90", "59746-216-06", "59746-216-09", "59746-216-15", "59746-217-06", "59746-217-09", "59746-218-06", "59746-218-09", "16729-225-01", "16729-225-16", "16729-225-17", "16729-225-19", "16729-226-01", "16729-226-16", "16729-227-01", "16729-227-16", "53746-511-30", "53746-511-60", "53746-511-90", "53746-511-01", "53746-511-05", "53746-511-10", "53746-514-30", "53746-514-60", "53746-514-90", "53746-514-01", "53746-514-05", "53746-514-10", "53746-515-30", "53746-515-60", "53746-515-90", "53746-515-01", "53746-515-05", "53746-515-10", "0574-1133-05", "0574-1133-10", "0574-1133-04", "0574-1133-16", "64980-706-01", "64980-706-50", "64980-707-01", "64980-707-50", "64980-708-01", "64980-708-50", "59746-216-01", "59746-216-05", "59746-216-10", "59746-217-01", "59746-217-05", "59746-218-01", "59746-218-05", "72603-134-01", "72603-134-02", "72603-134-03", "72603-135-01", "72603-135-02", "72603-136-01", "72603-136-02", "59651-426-01", "59651-426-05", "59651-426-99", "59651-427-01", "59651-427-05", "59651-428-01", "59651-428-05", "31722-691-11", "31722-691-47", "69238-2027-8", "69238-2027-2", "70771-1027-3", "70771-1027-9", "70771-1027-1", "70771-1027-5", "70771-1027-0", "70771-1027-4", "70771-1028-3", "70771-1028-9", "70771-1028-1", "70771-1028-5", "70771-1028-0", "70771-1028-4", "70771-1029-3", "70771-1029-9", "70771-1029-1", "70771-1029-5", "70771-1029-0", "70771-1029-4", "31722-094-30", "31722-094-01", "31722-094-10", "31722-094-05", "31722-095-30", "31722-095-01", "31722-095-10", "31722-095-05", "31722-096-30", "31722-096-01", "31722-096-10", "31722-096-05", "0025-1001-31", "0025-1041-31", "0025-1031-31", "68382-660-06", "68382-660-16", "68382-660-01", "68382-660-05", "68382-660-10", "68382-660-30", "68382-661-06", "68382-661-16", "68382-661-01", "68382-661-05", "68382-661-10", "68382-661-30", "68382-662-06", "68382-662-16", "68382-662-01", "68382-662-05", "68382-662-10", "68382-662-30", "53489-143-01", "53489-143-05", "53489-143-10", "53489-328-07", "53489-328-02", "53489-328-06", "53489-328-01", "53489-328-03", "53489-328-05", "53489-328-10", "53489-329-07", "53489-329-02", "53489-329-06", "53489-329-01", "53489-329-03", "53489-329-05", "53489-329-10", "0378-2146-01", "0378-2146-05", "0378-0243-01", "0378-0243-05", "0378-0437-01" ], "nui": [ "N0000175557", "N0000011310" ], "pharm_class_epc": [ "Aldosterone Antagonist [EPC]" ], "pharm_class_moa": [ "Aldosterone Antagonists [MoA]" ], "unii": [ "27O7W4T232" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LISINOPRIL", "drugdosagetext": "UNK,UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA212041", "ANDA208920", "ANDA077321", "NDA208401", "ANDA076102", "ANDA076164", "ANDA075903", "ANDA076059", "ANDA075743", "ANDA203508", "NDA019777", "ANDA077622" ], "brand_name": [ "LISINOPRIL", "QBRELIS", "ZESTRIL" ], "generic_name": [ "LISINOPRIL" ], "manufacturer_name": [ "Chartwell RX, LLC", "Quallent Pharmaceuticals Health LLC", "Azurity Pharmaceuticals, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)", "Solco healthcare U.S., LLC", "Camber Pharmaceuticals, Inc.", "Actavis Pharma, Inc.", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Exelan Pharmaceuticals, Inc", "BluePoint Laboratories", "Exelan Pharmaceuticals Inc.", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited" ], "product_ndc": [ "62135-640", "62135-641", "62135-642", "62135-643", "62135-644", "62135-645", "82009-062", "82009-063", "82009-064", "82009-065", "82009-066", "52652-3001", "23155-876", "23155-877", "23155-878", "23155-879", "23155-880", "23155-881", "43547-351", "43547-352", "43547-353", "43547-354", "43547-355", "43547-356", "31722-172", "31722-176", "31722-177", "31722-178", "31722-179", "31722-180", "0591-0885", "0591-0405", "0591-0406", "0591-0407", "0591-0408", "0591-0409", "68180-512", "68180-513", "68180-517", "68180-980", "68180-981", "68180-982", "68180-979", "68180-514", "68180-515", "68180-516", "72865-208", "72865-209", "72865-210", "72865-211", "72865-212", "72865-213", "76282-728", "76282-729", "76282-730", "76282-731", "76282-732", "76282-733", "68001-332", "68001-337", "68001-333", "68001-486", "68001-334", "68001-335", "68001-336", "43547-414", "43547-415", "43547-416", "43547-417", "43547-418", "43547-419", "76282-417", "76282-418", "76282-419", "76282-420", "76282-421", "76282-422", "24979-238", "24979-239", "24979-240", "24979-241", "24979-242", "24979-243", "65862-037", "65862-038", "65862-039", "65862-040", "65862-041", "65862-042" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LISINOPRIL" ], "rxcui": [ "197884", "205326", "311353", "311354", "314076", "314077", "1806884", "1806890", "104375", "104376", "104377", "104378", "206771", "213482" ], "spl_id": [ "462a5023-e5a0-692a-e063-6294a90a7236", "d2b42923-6e5f-47a1-9b31-4d019142a102", "461e97d5-c8b3-75a7-e063-6394a90a6ec6", "cb748971-2531-4478-8dff-e01cd87dec09", "61b942b0-3ad3-49d4-8321-c3b01f0d7ce1", "cfe12692-404c-ae05-e053-2995a90aa182", "01764c1d-aebe-4a46-920c-4b5f8cca8acb", "6723a96d-02f8-40c2-95ec-89a7053a7117", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "c3c02066-1571-4291-ae9a-fd50a43486ad", "c5fac2c4-de1f-49d3-e053-2a95a90a5285", "1ed80b02-cb3b-41c5-ab33-ff0106b8792d", "3e79fbc7-ef6e-4f2f-99a3-7ae3c1e1eec7", "7875efff-59e3-4f68-84c5-e3c9c16d6a3c", "99502ee9-cea6-473a-91c1-e4b4ded719e2", "337644b9-adae-41c1-9a9c-8d879ab355d2" ], "spl_set_id": [ "8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce", "f2e09150-22f2-4028-b214-917d686200ad", "9f6e4e57-a489-4b36-b093-b93865d3717c", "c6c55efa-36bd-4613-98ca-2eb589a31e53", "e299d477-a612-4af4-b6aa-f5addc8a736d", "8f20acd7-2635-4a9b-b732-2a84ea93dea7", "43e2c8d1-3704-4323-bcaf-f582572b81f7", "7d6c31e2-b5a4-4279-8013-a8dad37ea73b", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "4aad4d30-3e18-489c-80ad-ccf7532bb933", "34ebeea1-6812-4697-84c4-b2ae4f39e55f", "f8d16c85-50e2-4d99-afae-6fb902734e42", "1bc69836-a659-4e3b-84a7-a00b7c4dc268", "838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "0e6364a4-6d66-4151-8197-d45e2a762895", "387068e7-7fb9-44f3-ae1c-e45ebc755a3e" ], "package_ndc": [ "62135-640-31", "62135-640-90", "62135-641-31", "62135-641-90", "62135-642-31", "62135-642-90", "62135-643-31", "62135-643-90", "62135-644-31", "62135-644-90", "62135-645-31", "62135-645-90", "82009-062-05", "82009-063-10", "82009-064-10", "82009-065-10", "82009-066-10", "52652-3001-1", "23155-876-01", "23155-876-05", "23155-877-01", "23155-877-10", "23155-878-01", "23155-878-10", "23155-879-01", "23155-879-10", "23155-880-01", "23155-880-05", "23155-881-01", "23155-881-10", "43547-351-50", "43547-351-10", "43547-351-03", "43547-352-11", "43547-352-10", "43547-353-11", "43547-353-10", "43547-353-03", "43547-354-11", "43547-354-10", "43547-354-03", "43547-355-11", "43547-355-10", "43547-355-03", "43547-355-50", "43547-356-11", "43547-356-10", "31722-172-01", "31722-172-05", "31722-176-01", "31722-176-10", "31722-177-01", "31722-177-10", "31722-178-01", "31722-178-10", "31722-179-01", "31722-179-05", "31722-180-01", "31722-180-10", "0591-0405-01", "0591-0405-05", "0591-0406-01", "0591-0406-10", "0591-0407-01", "0591-0407-10", "0591-0408-01", "0591-0408-10", "0591-0885-01", "0591-0409-01", "0591-0409-05", "68180-512-02", "68180-512-30", "68180-512-09", "68180-512-01", "68180-512-03", "68180-513-30", "68180-513-03", "68180-513-01", "68180-513-09", "68180-513-02", "68180-513-05", "68180-517-03", "68180-517-01", "68180-517-30", "68180-517-09", "68180-517-04", "68180-517-02", "68180-980-03", "68180-980-30", "68180-980-01", "68180-980-09", "68180-980-05", "68180-980-02", "68180-981-01", "68180-981-03", "68180-981-30", "68180-981-09", "68180-981-02", "68180-981-05", "68180-982-01", "68180-982-02", "68180-982-30", "68180-982-03", "68180-982-09", "68180-979-01", "68180-979-03", "68180-979-30", "68180-979-09", "68180-514-01", "68180-514-02", "68180-514-03", "68180-514-09", "68180-514-30", "68180-514-05", "68180-515-01", "68180-515-02", "68180-515-03", "68180-515-09", "68180-515-30", "68180-515-05", "68180-516-01", "68180-516-02", "68180-516-03", "68180-516-09", "68180-516-30", "72865-208-01", "72865-208-05", "72865-209-45", "72865-209-90", "72865-209-01", "72865-209-10", "72865-210-45", "72865-210-90", "72865-210-01", "72865-210-10", "72865-210-50", "72865-211-45", "72865-211-90", "72865-211-01", "72865-211-18", "72865-211-10", "72865-211-50", "72865-212-01", "72865-212-05", "72865-213-45", "72865-213-90", "72865-213-01", "72865-213-18", "72865-213-10", "76282-728-30", "76282-728-45", "76282-728-90", "76282-728-01", "76282-728-18", "76282-728-05", "76282-728-10", "76282-729-30", "76282-729-45", "76282-729-90", "76282-729-01", "76282-729-18", "76282-729-05", "76282-729-10", "76282-730-30", "76282-730-45", "76282-730-90", "76282-730-01", "76282-730-18", "76282-730-05", "76282-730-10", "76282-730-50", "76282-731-30", "76282-731-45", "76282-731-90", "76282-731-01", "76282-731-18", "76282-731-05", "76282-731-10", "76282-731-50", "76282-732-30", "76282-732-45", "76282-732-90", "76282-732-01", "76282-732-18", "76282-732-05", "76282-732-10", "76282-733-30", "76282-733-45", "76282-733-90", "76282-733-01", "76282-733-18", "76282-733-05", "76282-733-10", "68001-337-00", "68001-337-08", "68001-332-00", "68001-332-03", "68001-333-00", "68001-333-08", "68001-486-00", "68001-486-08", "68001-334-00", "68001-334-08", "68001-335-00", "68001-335-08", "68001-336-00", "43547-414-10", "43547-414-50", "43547-415-03", "43547-415-04", "43547-415-09", "43547-415-10", "43547-415-50", "43547-415-11", "43547-415-25", "43547-416-04", "43547-416-09", "43547-416-10", "43547-416-50", "43547-416-11", "43547-416-15", "43547-417-04", "43547-417-09", "43547-417-10", "43547-417-50", "43547-417-11", "43547-417-15", "43547-418-10", "43547-418-50", "43547-419-04", "43547-419-09", "43547-419-10", "43547-419-18", "43547-419-50", "43547-419-11", "43547-419-15", "43547-419-25", "76282-417-30", "76282-417-45", "76282-417-90", "76282-417-01", "76282-417-18", "76282-417-05", "76282-417-10", "76282-418-30", "76282-418-45", "76282-418-90", "76282-418-01", "76282-418-18", "76282-418-05", "76282-418-10", "76282-419-30", "76282-419-45", "76282-419-90", "76282-419-01", "76282-419-18", "76282-419-05", "76282-419-10", "76282-419-50", "76282-420-30", "76282-420-45", "76282-420-90", "76282-420-01", "76282-420-18", "76282-420-05", "76282-420-10", "76282-420-50", "76282-421-30", "76282-421-45", "76282-421-90", "76282-421-01", "76282-421-18", "76282-421-05", "76282-421-10", "76282-422-30", "76282-422-45", "76282-422-90", "76282-422-01", "76282-422-18", "76282-422-05", "76282-422-10", "24979-238-07", "24979-239-07", "24979-240-07", "24979-241-07", "24979-242-07", "24979-243-07", "65862-037-30", "65862-037-01", "65862-037-00", "65862-037-05", "65862-037-99", "65862-038-30", "65862-038-01", "65862-038-00", "65862-038-05", "65862-038-99", "65862-039-30", "65862-039-01", "65862-039-00", "65862-039-05", "65862-039-99", "65862-040-30", "65862-040-01", "65862-040-00", "65862-040-05", "65862-040-99", "65862-041-30", "65862-041-01", "65862-041-00", "65862-041-05", "65862-041-99", "65862-042-30", "65862-042-01", "65862-042-00", "65862-042-05", "65862-042-99", "31722-172-31", "31722-176-31", "31722-177-31", "31722-178-31", "31722-179-31", "31722-180-31" ], "unii": [ "E7199S1YWR" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CARDIZEM", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA018602" ], "brand_name": [ "CARDIZEM" ], "generic_name": [ "DILTIAZEM HYDROCHLORIDE" ], "manufacturer_name": [ "Bausch Health US LLC" ], "product_ndc": [ "0187-0771", "0187-0772", "0187-0791", "0187-0792" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DILTIAZEM HYDROCHLORIDE" ], "rxcui": [ "831054", "831055", "831102", "831103", "831137", "833217", "833219", "834393" ], "spl_id": [ "340462fa-5523-448e-e063-6294a90a4eab" ], "spl_set_id": [ "f3e7ecef-f360-4987-a4f5-933214130ab2" ], "package_ndc": [ "0187-0771-47", "0187-0771-55", "0187-0772-47", "0187-0791-47", "0187-0792-47" ], "unii": [ "OLH94387TE" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALLOPURINOL", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA203154", "ANDA212363", "ANDA071450", "ANDA204467", "ANDA214443", "NDA018832", "NDA018877", "ANDA217748", "ANDA077353", "ANDA018659", "ANDA210117", "ANDA215091", "ANDA071586", "ANDA071587", "NDA020298", "ANDA211820", "NDA016084", "ANDA075798" ], "brand_name": [ "ALLOPURINOL", "ALOPRIM" ], "generic_name": [ "ALLOPURINOL" ], "manufacturer_name": [ "Accord Healthcare Inc.", "Gland Pharma Limited", "Sun Pharmaceutical Industries, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Florida Pharmaceutical Products, LLC", "Harman Finochem Limited", "Indoco Remedies Limited", "Actavis Pharma, Inc.", "Camber Pharmaceuticals, Inc.", "Chartwell RX, LLC", "Mylan Pharmaceuticals Inc.", "Zydus Lifesciences Limited", "Aurobindo Pharma Limited", "NorthStar RxLLC", "Dr. Reddy's Laboratories Limited", "Fresenius Kabi USA, LLC", "Mylan Institutional LLC", "Zydus Pharmaceuticals (USA) Inc.", "Unichem Pharmaceuticals (USA), Inc.", "Rising Pharma Holdings, Inc.", "XLCare Pharmaceuticals Inc.", "Par Health USA, LLC" ], "product_ndc": [ "16729-134", "16729-135", "68083-380", "53489-156", "53489-157", "23155-693", "23155-694", "71921-240", "71921-242", "71921-241", "82638-112", "82638-113", "14445-170", "14445-171", "14445-172", "0591-5543", "0591-5544", "31722-252", "31722-253", "62135-516", "62135-517", "0378-0137", "0378-0181", "70771-1126", "70771-1127", "70771-1907", "59651-285", "59651-286", "16714-576", "16714-577", "55111-729", "55111-730", "65219-380", "67457-187", "70710-1209", "70710-1210", "70710-2009", "29300-349", "29300-350", "16571-883", "16571-884", "16571-885", "72865-303", "72865-304", "0603-2115", "0603-2116" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "ALLOPURINOL", "ALLOPURINOL SODIUM" ], "rxcui": [ "197319", "197320", "252931", "245422", "261265" ], "spl_id": [ "40820fd2-3759-d43f-e063-6394a90a7c93", "6a0eaf66-34ca-4ba5-a2c6-a3c369ddf30c", "4c3692cf-dd55-f58c-e063-6394a90a1373", "43518352-e2b6-4133-97fc-860d3eeea074", "88cf17e7-9773-490a-992b-63525120cadc", "2b4201b6-c125-05d2-e063-6294a90a58c1", "7394738d-e6ca-4be9-9fb8-28702362abc5", "f7e04d88-1d9b-47e6-a9ad-deb08af3c098", "2a7490a6-7492-4fe1-b0f5-0e22bd0d458a", "4b432cc5-11c8-4450-e063-6394a90a1053", "38f49ed2-9641-404b-8146-5555064b86e8", "183fab96-5c7b-4fcc-a475-5d1832bbf9c6", "ef67cf70-5cf4-4b0d-86a5-c5af60228180", "0f560d11-3ba5-4dd4-8c20-ed9b43bfd69a", "c3be239e-a0b5-fb8d-2ae6-372cef6fa362", "2d2f4a09-b8bd-47ff-87db-a615efc34c4c", "35f241ea-eeb8-41b3-9596-be40eb9af06d", "95c7021b-a1a5-4a7f-aacf-275a64fe8b58", "25a9c596-5898-419b-b8bb-c2574fd23d54", "14a0ad9d-4145-4869-9d8d-747e5d7bfb44", "47dd9bd8-06e7-b387-e063-6294a90a74d4", "14909994-d957-4d81-a6e6-68d64107fd1b" ], "spl_set_id": [ "682dd8b8-fc6e-47c5-95b7-82d7ad96b750", "4839e842-511e-4c72-9153-2b7e4e1954e2", "fd8f8b8b-f25e-46e9-969a-65363b66e09b", "ad6950d4-2cdd-44ac-9b8a-120716460e70", "815af471-5985-4819-936d-1f5f3d871ef8", "0780dc78-d287-d5db-e063-6294a90aa1dd", "48a9a6c3-4604-421e-a323-1133888aaf76", "a80fe56f-8d03-423f-8e2a-7ec8c9e5045b", "60750373-7146-455a-8d12-d0e32d2d4bc8", "cdc3f33b-ff2b-4a84-a820-51a497fdf3d9", "bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480", "9232f484-a5f6-4c63-b7f4-b510d2827159", "311ca755-c022-4251-97eb-dd9be86a993f", "95a1ca8c-9855-4b11-92cd-6fdc144f0d3b", "19a138b8-d225-03e6-f762-abe71560204b", "2caf5eed-2408-4ce0-bd0d-04f4c90e434d", "10cc918f-aa44-415b-932d-2404695ac449", "8b926e62-3a9c-424a-833a-8169e55a1f15", "e3face45-f920-46a0-b707-6a66aa9735bd", "30ad5ba2-1cef-4933-b104-0597f6a2aaa2", "fc7973c8-d846-4eca-ab0d-d30228035ba2", "fbac3b4f-dc23-4359-ac3f-2b3fdde41af2" ], "package_ndc": [ "16729-134-10", "16729-134-01", "16729-134-16", "16729-134-17", "16729-135-10", "16729-135-01", "16729-135-16", "16729-135-17", "68083-380-01", "53489-157-01", "53489-157-05", "53489-157-10", "53489-157-07", "53489-157-02", "53489-156-01", "53489-156-05", "53489-156-10", "53489-156-02", "23155-693-01", "23155-693-10", "23155-694-01", "23155-694-05", "71921-240-33", "71921-240-01", "71921-240-50", "71921-240-60", "71921-242-01", "71921-242-50", "71921-242-60", "71921-241-09", "82638-112-01", "82638-112-02", "82638-112-03", "82638-112-04", "82638-113-02", "82638-113-03", "82638-113-04", "14445-170-30", "14445-170-01", "14445-170-05", "14445-170-00", "14445-171-01", "14445-171-05", "14445-171-00", "14445-172-90", "14445-172-01", "14445-172-05", "14445-172-00", "14445-172-02", "14445-172-10", "0591-5543-01", "0591-5543-10", "0591-5544-01", "0591-5544-05", "31722-252-90", "31722-252-01", "31722-252-05", "31722-252-10", "31722-253-90", "31722-253-01", "31722-253-05", "31722-253-10", "62135-516-90", "62135-516-31", "62135-517-90", "62135-517-31", "0378-0137-01", "0378-0137-10", "0378-0181-01", "0378-0181-05", "70771-1126-1", "70771-1126-0", "70771-1127-1", "70771-1127-5", "70771-1127-0", "70771-1907-0", "70771-1907-9", "59651-285-01", "59651-285-99", "59651-286-01", "59651-286-05", "16714-576-01", "16714-576-02", "16714-576-03", "16714-576-04", "16714-577-01", "16714-577-02", "55111-729-01", "55111-729-10", "55111-730-01", "55111-730-05", "65219-380-30", "67457-187-50", "70710-1209-1", "70710-1209-0", "70710-1210-1", "70710-1210-5", "70710-1210-0", "70710-2009-9", "70710-2009-0", "29300-349-01", "29300-349-05", "29300-349-10", "29300-350-01", "29300-350-05", "29300-350-10", "16571-883-09", "16571-883-01", "16571-883-50", "16571-883-10", "16571-884-09", "16571-884-01", "16571-884-50", "16571-884-10", "16571-885-09", "16571-885-01", "16571-885-50", "16571-885-10", "72865-303-90", "72865-303-01", "72865-303-05", "72865-303-10", "72865-304-90", "72865-304-01", "72865-304-05", "72865-304-10", "0603-2115-93", "0603-2115-21", "0603-2115-28", "0603-2115-32", "0603-2115-02", "0603-2115-04", "0603-2116-02", "0603-2116-21", "0603-2116-28", "0603-2116-32" ], "nui": [ "N0000175698", "N0000000206" ], "pharm_class_epc": [ "Xanthine Oxidase Inhibitor [EPC]" ], "pharm_class_moa": [ "Xanthine Oxidase Inhibitors [MoA]" ], "unii": [ "63CZ7GJN5I", "428673RC2Z" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METFORMIN", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA200690", "ANDA209674", "ANDA209313" ], "brand_name": [ "METFORMIN HYDROCHLORIDE", "METFORMIN" ], "generic_name": [ "METFORMIN", "METFORMIN ER 500 MG", "METFORMIN ER 750 MG" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Ingenus Pharmaceuticals, LLC", "Granules Pharmaceuticals Inc." ], "product_ndc": [ "0378-6001", "0378-6002", "50742-633", "50742-634", "70010-491", "70010-492" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "1807894", "1807917", "860975", "860981" ], "spl_id": [ "2a0bac1b-3575-4b62-a74b-07f54ba064af", "3a97a225-ff03-4d81-a2fe-7f66611cc4c1", "537f5fd2-89a1-d029-e063-6394a90a9d0e" ], "spl_set_id": [ "7e41818c-60e9-4bcf-9586-7bb8d33d5e89", "49a0b5c2-ebaf-4c4c-905f-dfd1962ac647", "6d6ee6f8-9650-ff4f-e053-2991aa0acf19" ], "package_ndc": [ "0378-6002-91", "0378-6001-91", "50742-633-60", "50742-633-90", "50742-633-10", "50742-634-30", "50742-634-60", "50742-634-10", "70010-491-01", "70010-491-05", "70010-491-10", "70010-491-18", "70010-491-19", "70010-491-09", "70010-492-01", "70010-492-05", "70010-492-20", "70010-492-21" ], "unii": [ "786Z46389E" ] } }, { "drugcharacterization": "2", "medicinalproduct": "REBIF", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "004", "drugdosagetext": "40 ?G, THREE TIMES A WEEK", "drugadministrationroute": "058", "drugindication": "MULTIPLE SCLEROSIS", "drugrecurreadministration": "3", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CYANOCOBALAMIN", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA206503", "ANDA214655", "ANDA213874", "ANDA214390", "ANDA080737", "ANDA209255", "ANDA217839", "ANDA212458", "ANDA080515", "ANDA214316", "NDA021642", "ANDA209429", "ANDA210629", "ANDA215417", "ANDA080557", "ANDA215107" ], "brand_name": [ "CYANOCOBALAMIN", "NASCOBAL", "NON-PROPRIETARY NAME" ], "generic_name": [ "CYANOCOBALAMIN" ], "manufacturer_name": [ "Somerset Therapeutics, LLC", "Zydus Pharmaceuticals USA Inc.", "AuroMedics Pharma LLC", "Plano Pharmaceuticals Inc.", "BluePoint Laboratories", "Vitruvias Therapeutics", "Meitheal Pharmaceuticals Inc.", "Padagis Israel Pharmaceuticals Ltd", "Hikma Pharmaceuticals USA Inc.", "Par Health USA, LLC", "Xseer Pharmaceuticals", "American Regent, Inc.", "NorthStar RxLLC", "Lupin Pharmaceuticals,Inc.", "Gland Pharma Limited", "SOLA Pharmaceuticals", "Lifestar Pharma LLC", "Fresenius Kabi USA, LLC", "Zydus Lifesciences Limited", "Sagent Pharmaceuticals" ], "product_ndc": [ "70069-005", "70069-172", "70710-1663", "70710-1664", "70710-1665", "55150-364", "87188-111", "87188-112", "87188-113", "68001-542", "69680-112", "69680-113", "69680-121", "68001-640", "71288-303", "45802-491", "0143-9619", "0143-9621", "0143-9620", "71288-300", "71288-301", "71288-302", "49884-270", "85551-120", "0517-0031", "0517-0032", "0517-0130", "70069-171", "72603-650", "43386-237", "68083-449", "68083-561", "68083-562", "70512-840", "70756-635", "70756-636", "70756-637", "63323-044", "70771-1688", "70771-1689", "70771-1690", "25021-502" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "SUBCUTANEOUS", "NASAL" ], "substance_name": [ "CYANOCOBALAMIN" ], "rxcui": [ "309594", "861113", "861115" ], "spl_id": [ "a10756d3-74a9-4adf-9d2a-0bbac8ad941b", "6ac6e28b-b969-4b66-bc1e-cca8a2cb66f3", "a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7", "4dd615b9-bf7c-f227-e063-6294a90acc91", "fab6a2d8-d9a0-2f8f-e053-6394a90a22bc", "7c3b0e85-bd17-4998-aaf4-1a873a357ab4", "44f5a26b-5965-9a7b-e063-6294a90a682a", "8a611106-589f-4896-baa7-653137dc27ab", "4cf650d9-6d6c-4112-88f2-cd2e94f1f416", "58925d4c-edff-43c6-9c9b-07102e84e41f", "b2ee60e7-c10a-45e1-81e8-28d6838161eb", "4291e3b9-37cb-4aa8-ac03-992725a41c1d", "51b65719-bc88-6e2d-e063-6294a90af60a", "28421ba1-7e37-429c-9c66-62cc36f5847c", "510f352d-5de9-48cb-9c96-71b08f089995", "bdfaf6c3-67ca-4323-a93e-72eba47805d9", "bb7b94e1-b5cd-486f-9e34-38fc9595547a", "771cf601-8f92-4e4f-a29f-b18e71b1ba96", "45724f81-e7a3-88cf-e063-6294a90ade9c", "5a299d3b-fc7a-44a0-a9bc-fbcd7eb83e19", "088857ed-e065-4c6e-aa7e-b2bfc072c130", "65f0f72b-691f-4cbb-a5d7-7579a133f457", "0a2dc386-15b3-45a3-91d7-80b9cf202c03", "8940ec64-b0cd-4f10-bc19-251146c9e552", "634b55ef-9667-46f7-9b3e-d41f4b7b819b", "b1dd7657-05bd-4062-89f1-9e11f0042f3e" ], "spl_set_id": [ "41ac0dc1-0a71-4c69-8e25-ba838f5f16a3", "e6712877-ace0-441c-99a9-adf567c0b9a2", "db84d0ea-5c15-47f5-bbe2-8d455e75695e", "4cbc05f6-4b31-4a5f-e063-6394a90a676c", "cdd4fd12-e214-43a6-b560-d56fc0d87190", "2117af8a-723f-4e2f-98a6-83ad2c423751", "5c603ad0-9023-44cc-955c-3988d5dcf0d3", "c6436212-9246-4e29-8540-9af992b667eb", "971e5f30-55c2-4193-9dd8-b43a1862b92a", "a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6", "9c37fd25-2143-410c-8d89-d39aa5c7b453", "697e0e52-c01b-4b53-9994-f79c46eb6b4f", "3bb870d8-128d-75ea-e063-6394a90a707b", "2fb653d6-e2b2-4969-831b-c0dc37b9c0cc", "617e44f8-df80-4764-85b9-be0fb6da8db3", "ce0183b3-4410-466a-b57d-cd360d461b7c", "efb7dc02-f0c9-4537-9e23-b641c428068c", "cd8d188a-fa5d-4580-bcb1-ac8617118cbb", "e559c6c8-2973-77fb-e053-2995a90af43d", "064c6841-3ed2-417f-a77c-a730785b6036", "b1e35c97-2157-454e-967f-53a4300827de", "ccf5b124-083d-4465-a666-c1bc6e84d630", "8b1cdee5-3368-40e4-90bf-31a64df1f38a", "ef300a08-8212-40a9-847a-1b62348896dd", "acff4ff3-4435-4995-a117-dbfcdf72334a", "7e10c47d-1036-47c1-a0ed-6929636366c2" ], "package_ndc": [ "70069-005-01", "70069-005-10", "70069-172-01", "70069-172-10", "70069-172-25", "70710-1663-1", "70710-1663-7", "70710-1664-1", "70710-1664-6", "70710-1664-7", "70710-1665-1", "70710-1665-5", "55150-364-01", "55150-364-10", "55150-364-25", "87188-111-01", "87188-111-90", "87188-112-01", "87188-113-01", "68001-542-59", "68001-542-60", "69680-112-01", "69680-112-25", "69680-112-10", "69680-113-10", "69680-113-99", "69680-121-05", "69680-121-30", "69680-121-10", "68001-640-59", "68001-640-60", "71288-303-91", "71288-303-92", "45802-491-84", "0143-9621-01", "0143-9621-25", "0143-9620-01", "0143-9620-10", "0143-9619-01", "0143-9619-10", "71288-300-01", "71288-300-02", "71288-301-10", "71288-301-11", "71288-302-30", "49884-270-82", "49884-270-52", "85551-120-30", "0517-0031-01", "0517-0031-25", "0517-0032-01", "0517-0032-25", "0517-0130-01", "70069-171-05", "70069-171-10", "72603-650-01", "72603-650-25", "43386-237-70", "43386-237-60", "68083-449-25", "68083-561-25", "68083-562-01", "70512-840-01", "70512-840-25", "71288-300-91", "71288-300-92", "70756-635-10", "70756-635-25", "70756-636-25", "70756-636-10", "70756-637-05", "70756-637-88", "70756-637-10", "71288-303-01", "71288-303-02", "63323-044-41", "63323-044-44", "70771-1688-1", "70771-1688-7", "70771-1689-1", "70771-1689-6", "70771-1689-7", "70771-1690-1", "70771-1690-5", "63323-044-00", "63323-044-01", "25021-502-01" ], "nui": [ "M0022794", "N0000175951" ], "pharm_class_cs": [ "Vitamin B 12 [CS]" ], "pharm_class_epc": [ "Vitamin B12 [EPC]" ], "unii": [ "P6YC3EG204" ] } }, { "drugcharacterization": "2", "medicinalproduct": "THIAMINE", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA215692", "ANDA080556" ], "brand_name": [ "THIAMINE" ], "generic_name": [ "THIAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Caplin Steriles Limited", "Fresenius Kabi USA, LLC", "Armas Pharmaceuticals Inc.", "NorthStar Rx LLC" ], "product_ndc": [ "65145-129", "63323-013", "72485-507", "72603-139" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "THIAMINE HYDROCHLORIDE" ], "rxcui": [ "313324" ], "spl_id": [ "66c1e502-6c85-43a5-b9a7-76368ebd39bc", "3b09217b-e746-4523-95fa-b78fad431e32", "99612c11-05be-4741-8b1d-0900165ef943", "9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9", "f4790075-a740-4550-9d4c-69a00dac354c", "3bda958c-8ec2-4039-a7f0-96e2b94f9c26" ], "spl_set_id": [ "8909424c-9d5b-4e35-b2d3-da9d3316a4cc", "c3c9db74-95d4-487c-90c3-c810786fbaec", "af3f9344-f743-4bad-b319-53b96e13fee2", "9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9", "f4790075-a740-4550-9d4c-69a00dac354c", "ca4899c6-cea1-48d6-b0ae-9efcf67f6fcb" ], "package_ndc": [ "65145-129-01", "65145-129-25", "63323-013-21", "63323-013-09", "63323-013-41", "63323-013-26", "72485-507-01", "72485-507-25", "72603-139-01", "72603-139-25", "63323-013-01", "63323-013-02" ], "unii": [ "M572600E5P" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FOLIC ACID", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "brand_name": [ "VENTRIXYL", "FOLIC ACID", "QUIOFIC", "VENEXA", "VITRAMYN", "MULTITAM", "VITREXYL", "VITREXATE", "VITRANOL" ], "generic_name": [ "FOLIC ACID" ], "manufacturer_name": [ "PureTek Corporation", "Leading Pharma, LLC", "Amneal Pharmaceuticals of New York LLC", "Solubiomix, LLC", "Cadila Pharmaceuticals Limited", "Ayurax, LLC", "SUNRISE PHARMACEUTICAL, INC.", "Modavar Pharmaceuticals LLC", "Method Pharmaceuticals, LLC", "XGen Pharmaceuticals DJB, Inc.", "QUAGEN PHARMACEUTICALS LLC", "Rising Pharma Holdings, Inc.", "Amneal Pharmaceuticals LLC", "Fresenius Kabi USA, LLC", "Chartwell RX, LLC." ], "product_ndc": [ "59088-186", "69315-127", "53746-361", "69499-501", "59088-176", "71209-007", "73308-501", "11534-165", "72241-050", "58657-151", "59088-193", "39822-1100", "70752-231", "16571-881", "65162-361", "59088-525", "59088-164", "59088-167", "59088-171", "63323-184", "62135-210" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "CHOLECALCIFEROL", "RIBOFLAVIN", "NIACINAMIDE", "ASCORBIC ACID", "FOLIC ACID", "CYANOCOBALAMIN", "CALCIUM CARBONATE", "SELENIUM", "VITAMIN A ACETATE", "THIAMINE MONONITRATE", "ZINC OXIDE", "MANGANESE SULFATE", ".ALPHA.-TOCOPHEROL ACETATE, DL-", "MAGNESIUM OXIDE", "CHROMIUM NICOTINATE", "PYRIDOXINE HYDROCHLORIDE", "MOLYBDENUM" ], "spl_id": [ "286669b9-5e8e-a446-e063-6394a90a2287", "92322e52-3179-4738-8c8a-14fef62311d4", "299a16c1-9627-45e2-a30c-e0f07ae9399a", "c0176981-bd6e-480f-9167-80555050b025", "f204b6b0-92af-3c22-e053-2995a90ad0aa", "fdcdd5ea-a352-4b01-a972-2ed5a82e3a61", "f6a753c1-e141-42a5-b758-7faad81c9427", "5250e701-9f7a-42a8-bae9-95c4779f06aa", "f1dbb47b-a3bd-472b-b565-053e5db411eb", "41b4d71d-2dc2-36bd-e063-6294a90af1e1", "548ee394-41b9-d346-e063-6394a90a0773", "48eb23cf-7425-a5cc-e063-6294a90a5021", "067af2c9-3769-40d4-a991-217390ece384", "a5219f26-2238-4666-9aae-9c98b3003079", "e5ed5369-340d-40ad-b863-c02fd63d5911", "4f5f0e70-672d-571b-e063-6394a90ad1da", "f2048b24-433c-98ba-e053-2995a90a5e85", "f204b4b3-176f-8839-e053-2a95a90a7115", "2445290b-6803-4364-ab42-65e6c550fdcd", "2589605c-12b7-ed10-e063-6294a90ab52b" ], "spl_set_id": [ "c29dc729-93be-2a20-e053-2a95a90a8ca3", "1ba8c407-9613-4319-ac40-0a429cb0f3f4", "fd85395e-6a0b-4072-a80b-36095c0c6dd6", "b868b314-591d-458b-be82-2bcd0b73cce1", "ba130779-cdfd-086d-e053-2a95a90a2590", "103c2cdd-5822-48ba-b62a-e2b11aa444ef", "96618bf8-6c03-4df3-9896-b7ef27ca392a", "6854412b-7ecb-4107-85eb-730f14e23f06", "0eea15e4-7e5d-44e9-818b-a0bdf5271c78", "b9c315ff-cecb-8b75-e053-2995a90aa204", "c8af7616-5178-6df0-e053-2a95a90a334d", "c5b2b84d-9f5e-4b81-ba10-9f2854e5dce9", "354366ea-3702-4706-9fc0-0244b7278bd8", "0baa10dd-6d1d-4946-8236-566451132da3", "c8fe09f0-b32b-43e3-8de7-ed38593b33b4", "cee15842-4a9e-c6ba-e053-2a95a90aebc5", "ae064a9e-daba-fa86-e053-2a95a90a16a7", "b34fee43-bea9-45b7-e053-2a95a90aad4d", "e215318c-4f8b-4711-ae76-f370d1da0f3b", "9a533666-8906-438e-adf7-11bb162ecb63" ], "package_ndc": [ "59088-186-54", "69315-127-01", "69315-127-10", "53746-361-01", "53746-361-10", "69499-501-75", "59088-176-54", "71209-007-05", "71209-007-11", "73308-501-75", "11534-165-01", "11534-165-03", "11534-165-90", "72241-050-05", "72241-050-11", "58657-151-10", "58657-151-01", "59088-193-54", "39822-1100-1", "70752-231-10", "70752-231-11", "16571-881-10", "16571-881-01", "65162-361-01", "65162-361-10", "65162-361-50", "65162-361-11", "59088-525-54", "59088-164-54", "59088-171-54", "59088-167-54", "63323-184-10", "62135-210-90", "62135-210-01", "62135-210-05", "62135-210-10", "62135-210-72", "62135-210-97" ], "nui": [ "M0022797", "N0000175952", "N0000193618", "M0001797", "M0022794", "N0000175951" ], "pharm_class_cs": [ "Vitamin D [CS]", "Ascorbic Acid [CS]", "Vitamin B 12 [CS]" ], "pharm_class_epc": [ "Vitamin D [EPC]", "Vitamin C [EPC]", "Vitamin B12 [EPC]" ], "unii": [ "1C6V77QF41", "TLM2976OFR", "25X51I8RD4", "PQ6CK8PD0R", "935E97BOY8", "P6YC3EG204", "H0G9379FGK", "H6241UJ22B", "3LE3D9D6OY", "8K0I04919X", "SOI2LOH54Z", "W00LYS4T26", "WR1WPI7EW8", "3A3U0GI71G", "A150AY412V", "68Y4CF58BV", "81AH48963U" ], "application_number": [ "ANDA040796", "ANDA040625", "NDA216395", "ANDA202437", "ANDA204418", "ANDA211064", "ANDA202522", "ANDA091145", "ANDA089202", "ANDA090035" ], "rxcui": [ "310410", "2707361", "2733998", "237786" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LORAZEPAM", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA076150", "NDA018140", "ANDA203572", "ANDA217598", "ANDA218597", "ANDA072755", "ANDA090260", "NDA214826", "ANDA091383", "NDA017794", "ANDA072926", "ANDA072927", "ANDA072928", "ANDA079244", "ANDA071591", "ANDA077396", "ANDA078203", "ANDA074243", "ANDA076045" ], "brand_name": [ "LORAZEPAM", "LOREEV XR", "ATIVAN" ], "generic_name": [ "LORAZEPAM" ], "manufacturer_name": [ "International Medication Systems, Limited", "Hikma Pharmaceuticals USA Inc.", "Aurolife Pharma LLC", "Fresenius Kabi USA, LLC", "Rising Pharma Holdings, Inc.", "Pharmaceutical Associates, Inc.", "Almatica Pharma LLC", "Amneal Pharmaceuticals LLC", "Bausch Health US LLC", "Teva Pharmaceuticals USA, Inc.", "Chartwell RX, LLC", "ANI Pharmaceuticals, Inc.", "Civica, Inc.", "Leading Pharma, LLC", "Hospira, Inc.", "SUN PHARMACEUTICAL INDUSTRIES INC" ], "product_ndc": [ "76329-8261", "0641-6207", "13107-083", "13107-084", "13107-085", "65219-368", "64980-627", "64980-628", "64980-629", "0054-3532", "0121-0770", "0641-6048", "0641-6050", "0641-6049", "0641-6051", "52427-658", "52427-661", "52427-663", "52427-667", "65162-687", "0187-0063", "0187-0064", "0187-0065", "0093-3425", "0093-3426", "0093-3427", "62135-549", "62135-861", "62135-862", "62135-863", "62559-195", "62559-196", "62559-197", "0641-6044", "0641-6046", "0641-6045", "0641-6047", "72572-380", "69315-904", "69315-905", "69315-906", "0409-1985", "0409-1539", "63304-772", "63304-773", "63304-774", "0641-6000", "0641-6003", "0641-6002", "0641-6001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS", "ORAL" ], "substance_name": [ "LORAZEPAM" ], "rxcui": [ "238100", "197900", "197901", "197902", "1665188", "311376", "238101", "1665326", "2569564", "2569571", "2569573", "2569575", "2569577", "2569580", "2594600", "2594603", "104719", "206821", "206828", "763028", "763029", "206819", "206820", "1665190", "1665327" ], "spl_id": [ "b85a6695-55b9-4780-a803-33f8f2464138", "4f2988b1-2854-4051-962f-07cc925608ab", "67012944-0947-4e64-adab-869993f2f709", "5cd2d0d8-9639-4e96-aafd-4991ad35fabc", "b47aeb6e-aa7a-469b-a709-15df0e99ea79", "a0e90170-76ad-4493-991c-551903b42b09", "e5f67a93-3cca-391b-e053-2a95a90af637", "462a13da-259a-40e7-bd5b-f7f42ae025b7", "329ddfc8-cf47-4584-a101-4727751e1005", "1ce5f319-4e44-ae8e-b6be-ecf54a0d345a", "99b5d0cb-3d61-497c-9b51-7d0939f923a0", "93bdf2de-1222-44a4-b4d5-2280f9ce58d8", "979c1de1-fca5-4909-9abf-a568e2a8a3de", "044c464b-af13-d50f-e063-6394a90ade25", "26588a04-2ea3-599b-e063-6394a90aa2a0", "f94c8e8d-899c-4eb4-8272-9054155896ec", "7c73dbc6-2623-4443-9b05-97dec7a0be2e", "4b66b887-9825-4a33-9eb8-d483666e8b88", "40249bb6-0d25-4b2f-aa4b-85c15af6bf8b", "0280cc35-0696-4091-a000-2314f292feb2", "b8fbb599-96d9-4866-908d-d8be424e5ee3", "209b0091-c890-4f69-a693-d0594c2606fe" ], "spl_set_id": [ "7dda070d-7809-46c4-8592-eb4e4c509707", "b79b38ee-c29d-4099-964f-000031f47f5a", "5b851f67-309d-4ef3-8b4b-ade8908256ea", "b2487467-a63f-48b5-b0de-3a6ce6672d50", "386255e2-65aa-48ce-9eb1-246f1493cc14", "5ff82103-cc57-4af9-9362-82a7c686271d", "711b60a3-028d-41d4-aa17-8f976e6df23e", "462a13da-259a-40e7-bd5b-f7f42ae025b7", "4084fa74-9fd2-45ef-9d56-27bfa31d4e46", "227734c1-bf01-9607-73ea-5a1f38a89bd9", "bf265c2e-ab2f-42e5-96cf-3998eb5a644d", "89057c93-8155-4040-acec-64e877bd2b4c", "1bf22e97-9425-484d-bac6-519c6bae6a37", "e075c78d-f0c6-4380-b769-bb8833d23ba5", "6b0619c5-b9e9-47e7-97b5-7e581e67cf5f", "787240e9-67b5-4af3-b16d-7cf314e3f2e3", "e9b54e42-04cf-4c62-90e1-36f7b31a4e81", "5140798d-8571-41fb-84a4-e182aac3f64c", "5ca13415-4b77-4131-a9d2-6db26bc49167", "20140b19-846b-425f-b191-670e17809945", "0c1caa9c-9ef1-459c-86c3-adb939130a9f", "5fc0e987-61c9-40c4-b0d5-fcea07c8733e" ], "package_ndc": [ "76329-8261-1", "0641-6207-01", "0641-6207-25", "13107-083-10", "13107-083-01", "13107-083-05", "13107-083-99", "13107-084-10", "13107-084-01", "13107-084-05", "13107-084-99", "13107-085-10", "13107-085-01", "13107-085-05", "13107-085-99", "65219-368-01", "65219-368-02", "64980-627-01", "64980-627-10", "64980-627-50", "64980-628-01", "64980-628-10", "64980-628-50", "64980-629-01", "64980-629-10", "64980-629-50", "0054-3532-44", "0121-0770-01", "65219-368-14", "65219-368-24", "0641-6048-01", "0641-6048-25", "0641-6050-01", "0641-6050-10", "0641-6049-01", "0641-6049-25", "0641-6051-01", "0641-6051-10", "52427-658-30", "52427-661-30", "52427-663-30", "52427-667-30", "65162-687-84", "0187-0063-01", "0187-0063-50", "0187-0063-10", "0187-0064-01", "0187-0064-50", "0187-0064-10", "0187-0065-01", "0187-0065-50", "0187-0065-10", "0093-3425-01", "0093-3425-05", "0093-3425-10", "0093-3426-01", "0093-3426-05", "0093-3426-10", "0093-3427-01", "0093-3427-05", "0093-3427-10", "62135-549-43", "62135-861-01", "62135-862-01", "62135-863-01", "62559-195-01", "62559-195-05", "62559-195-10", "62559-196-01", "62559-196-05", "62559-196-10", "62559-197-01", "62559-197-05", "62559-197-10", "0641-6044-01", "0641-6044-25", "0641-6046-01", "0641-6046-10", "0641-6045-01", "0641-6045-25", "0641-6047-01", "0641-6047-10", "72572-380-01", "72572-380-25", "69315-904-01", "69315-904-05", "69315-904-10", "69315-905-01", "69315-905-05", "69315-905-10", "69315-906-01", "69315-906-05", "69315-906-10", "0409-1539-03", "0409-1539-31", "0409-1985-03", "0409-1985-30", "63304-772-90", "63304-772-01", "63304-772-05", "63304-772-10", "63304-773-90", "63304-773-01", "63304-773-05", "63304-773-10", "63304-774-90", "63304-774-01", "63304-774-05", "63304-774-10", "0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "O26FZP769L" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10005066", "primarysourcecountry": "ES", "occurcountry": "ES", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "ES-US-EMD SERONO, INC.-7273270", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "ES-US-EMD SERONO, INC.-7273270" }, "primarysource": { "reportercountry": "ES", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "44", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Disability", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Multiple sclerosis relapse", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugauthorizationnumb": "103780", "drugdosageform": "INJECTION", "drugadministrationroute": "058", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "1", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10005311", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "2", "companynumb": "US-US-EMD SERONO, INC.-7274140", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "US-US-EMD SERONO, INC.-7274140" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Tremor", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Muscle disorder", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Injection site erythema", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugbatchnumb": "AU007689", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "44", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosageform": "INJECTION", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "610", "drugstartdate": "201401", "actiondrug": "4", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10005376", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "US-US-EMD SERONO, INC.-7110344", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "US-US-EMD SERONO, INC.-7110344" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "47", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Colon cancer", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Peroneal nerve palsy", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugauthorizationnumb": "103780", "drugdosageform": "INJECTION", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20030116", "drugenddateformat": "610", "drugenddate": "200802", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "44", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugstartdateformat": "102", "drugstartdate": "20120220", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TYSABRI", "drugindication": "MULTIPLE SCLEROSIS", "actiondrug": "5", "openfda": { "application_number": [ "BLA125104" ], "brand_name": [ "TYSABRI" ], "generic_name": [ "NATALIZUMAB" ], "manufacturer_name": [ "Biogen Inc." ], "product_ndc": [ "64406-008" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "NATALIZUMAB" ], "rxcui": [ "477484", "603541" ], "spl_id": [ "119c87a9-d153-4796-9525-694afdcdc1d6" ], "spl_set_id": [ "c5fdde91-1989-4dd2-9129-4f3323ea2962" ], "package_ndc": [ "64406-008-01" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "3JB47N2Q2P" ] } }, { "drugcharacterization": "1", "medicinalproduct": "AVONEX", "drugindication": "MULTIPLE SCLEROSIS", "drugstartdateformat": "610", "drugstartdate": "200803", "actiondrug": "5", "openfda": { "application_number": [ "BLA103628" ], "brand_name": [ "AVONEX" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "Biogen Inc." ], "product_ndc": [ "59627-002", "59627-333", "59627-222", "59627-003" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "727813", "727816", "797544", "1650899", "1650901" ], "spl_id": [ "8c84155d-4436-404a-bb05-aee683889f0b" ], "spl_set_id": [ "d70a39cc-de15-4c12-a1ec-8063b69ea0e1" ], "package_ndc": [ "59627-333-04", "59627-222-05", "59627-003-01", "59627-002-07", "59627-002-06" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10006235", "primarysourcecountry": "BR", "occurcountry": "BR", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnesslifethreatening": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "1", "companynumb": "BR-US-EMD SERONO, INC.-7238044", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "BR-US-EMD SERONO, INC.-7238044" }, "primarysource": { "reportercountry": "BR", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "25", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Female sterilisation", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Apathy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Depression", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "44", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20041118", "actiondrug": "4", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10006402", "primarysourcecountry": "BR", "occurcountry": "BR", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "1", "companynumb": "BR-US-EMD SERONO, INC.-7236829", "duplicate": "1", "reportduplicate": { "duplicatesource": "EMD SERONO INC", "duplicatenumb": "BR-US-EMD SERONO, INC.-7236829" }, "primarysource": { "reportercountry": "BR", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "25", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Urinary tract infection", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blindness unilateral", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Immunodeficiency", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Convulsion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vision blurred", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pharyngitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Muscle twitching", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "REBIF", "drugbatchnumb": "AU005428,AU006687", "drugauthorizationnumb": "103780", "drugstructuredosagenumb": "44", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosageform": "INJECTION", "drugindication": "RELAPSING-REMITTING MULTIPLE SCLEROSIS", "drugstartdateformat": "102", "drugstartdate": "20120730", "actiondrug": "4", "openfda": { "application_number": [ "BLA103780" ], "brand_name": [ "REBIF" ], "generic_name": [ "INTERFERON BETA-1A" ], "manufacturer_name": [ "EMD Serono, Inc." ], "product_ndc": [ "44087-0022", "44087-8822", "44087-0188", "44087-0044", "44087-3322", "44087-3344" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "INTERFERON BETA-1A" ], "rxcui": [ "758025", "758027", "758028", "758029", "758030", "758032", "795748", "795749", "1649994", "1649996", "1650003", "1650004", "1650011", "1650012", "1650268", "1650282" ], "spl_id": [ "037d2645-544b-41bb-bea8-00b578366ac6" ], "spl_set_id": [ "c6fcb5d2-8fcd-44fa-a838-b84ee5f44f0f" ], "package_ndc": [ "44087-8822-1", "44087-0188-1", "44087-0022-9", "44087-0022-3", "44087-0044-9", "44087-0044-3", "44087-3322-9", "44087-3322-1", "44087-3344-9", "44087-3344-1" ], "nui": [ "M0025715", "N0000191625" ], "pharm_class_cs": [ "Interferon-beta [CS]" ], "pharm_class_epc": [ "Interferon beta [EPC]" ], "unii": [ "XRO4566Q4R" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BACLOFEN", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA078401", "NDA208193", "ANDA214099", "ANDA217687", "ANDA212378", "ANDA215885", "NDA215422", "NDA020075", "ANDA209102", "ANDA217324", "ANDA217252", "ANDA214445", "NDA215602", "ANDA074584", "ANDA210048", "ANDA072234", "ANDA072235", "ANDA214374", "ANDA210315", "ANDA077241", "ANDA211555", "ANDA078220", "ANDA210777", "ANDA077068", "ANDA211659", "ANDA212067" ], "brand_name": [ "BACLOFEN", "LYVISPAH", "LIORESAL (BACLOFEN)", "BACLOFEN (INTRATHECAL)", "OZOBAX DS", "FLEQSUVY" ], "generic_name": [ "BACLOFEN" ], "manufacturer_name": [ "Northstar RxLLC", "Palmetto Pharmaceuticals Inc.", "Medcore LLC", "Micro Labs Limited", "Method Pharmaceuticals LLC", "Major Pharmaceuticals", "Amneal Pharmaceuticals LLC", "TruPharma LLC", "Nexus Pharmaceuticals LLC", "Slayback Pharma LLC", "Advagen Pharma Ltd", "Wilshire Pharmaceuticals, Inc.", "Lifestar Pharma LLC", "Advagen Pharma Ltd.,", "Upsher-Smith Laboratories, LLC", "Advagen Pharma Limited", "MAIA Pharmaceuticals, Inc.", "Aurobindo Pharma Limited", "Rosemont Pharmaceuticals LLC", "Teva Pharmaceuticals USA, Inc.", "TRUPHARMA, LLC", "Rising Pharma Holdings, Inc.", "Sagent Pharmaceuticals", "Chartwell RX, LLC", "Eywa Pharma Inc", "Lannett Company, Inc.", "MAlA Pharmaceuticals, Inc.", "Trifluent Pharma, LLC", "Par Health USA, LLC", "Zydus Pharmaceuticals (USA) Inc.", "Marlex Pharmaceuticals Inc", "XLCare Pharmaceuticals Inc.", "Azurity Pharmaceuticals, Inc.", "Zydus Lifesciences Limited", "SOLA Pharmaceuticals, LLC", "Unichem Pharmaceuticals (USA), Inc.", "ANI Pharmaceuticals, Inc." ], "product_ndc": [ "16714-071", "16714-072", "68134-403", "82461-717", "82461-718", "42571-427", "42571-428", "42571-429", "58657-730", "58657-932", "58657-731", "58657-732", "58657-931", "58657-930", "0904-7552", "0904-7553", "64896-076", "64896-077", "64896-078", "70121-2496", "70121-2501", "70121-2502", "70121-2504", "70121-2503", "70121-2505", "52817-318", "52817-319", "52817-320", "52817-321", "14789-161", "71225-140", "72888-103", "52536-600", "70756-085", "70756-288", "70756-289", "72888-466", "0832-1054", "0832-1055", "72888-009", "72888-010", "72888-202", "72888-011", "70511-122", "70511-124", "59651-394", "59651-395", "72834-602", "0172-4096", "0172-4097", "52817-620", "69528-302", "16571-169", "16571-171", "16571-172", "25021-680", "25021-678", "25021-679", "62135-472", "62135-473", "62135-474", "71930-006", "71930-066", "71930-007", "0527-1330", "0527-1337", "0527-1333", "70511-121", "73352-103", "0603-2406", "0603-2407", "70511-123", "70710-1285", "70710-1286", "70710-1609", "70710-1666", "10135-532", "10135-533", "72865-296", "72865-297", "72865-298", "52652-6001", "70771-1448", "70771-1449", "70771-1586", "70771-1868", "25021-681", "70512-782", "29300-343", "29300-474", "29300-344", "72888-145", "72888-146", "72888-147", "62559-204", "84386-035" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRATHECAL" ], "substance_name": [ "BACLOFEN" ], "rxcui": [ "197391", "197392", "2667941", "430902", "2586589", "2586595", "2586596", "2586598", "2586599", "2586601", "308516", "308517", "805678", "805679", "1666613", "1666620", "1666622", "1666623", "2679605", "2593376", "250976", "2667943", "1300890", "1047437", "2593382" ], "spl_id": [ "a3881489-a033-4a93-ba24-590e316103f3", "47426f2f-4630-5a83-e063-6294a90a88d1", "152e2f4d-157b-4dad-8d18-ab3f63792051", "0acb9150-3e4c-9f37-e063-6294a90a7fd6", "3aa113f3-27d5-328b-e063-6394a90af9e5", "5c3857ec-f6de-489c-909d-79cad21f784e", "d042d45f-7097-47e0-921f-0442e00d47e0", "d68a08e0-d0d9-4144-be01-47b636dfa7e1", "1645f54e-2eed-bd9b-e063-6294a90a848b", "2ac0f53e-48b5-5d84-e063-6294a90a8ac8", "f948e217-c9bb-4ec1-b5fb-864cc14afe4e", "3760a935-7c14-5771-e063-6394a90a1fb0", "461e14b2-890c-011c-e063-6294a90a0d4c", "97901dd3-f1e0-4fc8-86a1-5114e2095073", "374c7fbe-ca7e-09b4-e063-6394a90ab5fa", "45af8926-ad18-a93a-e063-6294a90a1dca", "490e18d8-694e-da7b-e063-6294a90ab450", "c15b60c7-4e21-4e28-898c-31e23052737a", "493c1b1f-7ee0-4a54-8e44-b2b015eb3850", "544cca2f-c73f-8fcc-e063-6394a90a67fb", "ba227be6-e946-423c-a9a6-e0626d889ea7", "0806a6f9-b626-f98e-e063-6294a90a84bb", "4ce95252-8c9b-2246-e063-6294a90a8b25", "ff66a259-5803-47a3-9558-87acf43f43a7", "81266703-bafa-4e31-a400-32fbfe1a849e", "9ae563da-240a-468d-bc42-ed4667df2392", "24246dff-9253-1075-e063-6394a90a75c0", "ff342eff-68ae-4190-96bb-f887fff1dd56", "153f6bd7-9462-4d92-b738-48e7807c5919", "58150ebf-c2d6-49be-a519-06d839637462", "3a73197c-59cf-621b-e063-6394a90a955b", "25fe173e-f3ce-4d70-adec-7e23e455679a", "c25028b0-ac87-4b40-b8e4-fef625b32ccb", "f96d29a2-071a-4a33-a57e-bb55eba0d660", "3f668f68-659e-2740-e063-6394a90a6264", "2d6876fe-19e5-fd4f-e063-6294a90a7960", "461e773b-ccc2-532d-e063-6294a90abad9", "2c2eb58e-8920-43f4-aaa9-6f5add3b35ae", "570e9773-fda9-492f-bdef-7dd6814fd3b2", "45723949-ac04-69ef-e063-6294a90a29a3", "513de439-4155-4a5d-a25c-bced499e293a", "45801dc3-fb9b-c31e-e063-6294a90aff35", "1c95cf7d-6db8-437d-9e33-f8ecb151eca6", "f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a" ], "spl_set_id": [ "0aac77fa-30c2-46c8-a04d-e6b8333ddd81", "2422746c-afec-ad30-e063-6394a90a0403", "13eca70c-3cc8-4317-83cf-ade3327e48c0", "f0abf768-3b19-452b-b56d-eb70441cfb18", "1a9db542-d2b0-141a-e063-6394a90acc11", "f328296e-0713-4acb-bcb5-c10d7838d380", "f8992a56-9010-4c4b-84d5-ddcc3e2c3317", "6f3bdcc0-ffc8-4911-8c35-958c8103a2c5", "68aa591e-ea98-4438-9a4a-4f7e9ea2b285", "68c9ade0-d783-43e9-8a3f-a16ec1501ec1", "9fad5ffc-afae-4c92-a672-ee636df45bc5", "2a43830f-a28b-ca15-e063-6294a90a6b1a", "4585aafe-0af8-4786-a419-6a7e76671ca2", "f9dd1b55-2984-446a-8146-2ab0f5211e15", "75ab298b-b2a7-458f-accc-5bfc89b89a16", "b2747a9d-5fca-4657-9e4b-4112607f30d8", "04dac0f6-cc6c-4959-9bca-a6e4a99690f3", "11ba5575-a856-414a-89f8-17f3a01de55b", "4679a275-9307-4b0f-a2eb-2d83227ea84d", "81a539b3-e547-4a62-ad1b-2eedb30be927", "5648c772-50cb-4961-996e-e68a8eb699ea", "f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7", "d8ddcec5-debe-42b4-a803-e65917cc6a54", "6eb46715-d72b-473f-b984-90024033d4a0", "d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51", "077aaf3b-1ca3-4599-a51a-6bbe39810ca8", "2a75db96-590a-43cf-aefb-3bbcb287dbf0", "7ec59f6b-7c4f-432d-ba27-442861806b6c", "f84f3f4c-17e6-43f1-9600-63b0b175837b", "e05080ef-53d9-4060-aaa4-86a6935467de", "890df151-f4eb-4244-97c4-f1f10912e753", "c17527be-661d-42f5-b6f6-56a681ba7870", "dfa6148c-693c-45f1-89be-0e77d39f313e", "cfc49176-8d01-4c39-9319-604dd087065c", "1b0f50c8-62e3-414d-96d3-5fd16e8043ab", "2b4908fb-47b5-4675-be9e-ca1ad48a7252", "9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa", "bb5c6faa-2933-44d1-8706-8302150be734", "ea32c39c-0ee3-4b5e-8da7-4c31db334bd8", "7b308b35-8c08-458d-860e-c78d057e8260", "b9199878-3fb4-46dc-adbb-b3d9dc3852d4", "d63af5f0-c275-480b-89b5-6cf1ad55ab63", "c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0", "f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a" ], "package_ndc": [ "16714-071-04", "16714-071-06", "16714-072-04", "16714-072-05", "68134-403-16", "82461-717-10", "82461-718-10", "42571-427-01", "42571-428-01", "42571-428-05", "42571-428-13", "42571-429-01", "42571-429-05", "42571-429-13", "58657-932-10", "58657-932-05", "58657-932-01", "58657-730-01", "58657-730-10", "58657-731-01", "58657-731-10", "58657-731-50", "58657-732-01", "58657-732-50", "58657-732-10", "58657-931-10", "58657-931-05", "58657-931-01", "58657-930-10", "58657-930-05", "58657-930-01", "0904-7552-61", "0904-7553-61", "64896-076-09", "64896-077-09", "64896-078-09", "70121-2501-1", "70121-2502-2", "70121-2504-2", "70121-2503-1", "70121-2505-2", "70121-2496-5", "52817-319-10", "52817-320-10", "52817-320-50", "52817-320-00", "52817-318-10", "52817-321-10", "52817-321-50", "52817-321-00", "14789-161-05", "71225-140-01", "72888-103-24", "52536-600-11", "52536-600-12", "70756-085-11", "70756-288-11", "70756-288-12", "70756-288-01", "70756-288-99", "70756-289-11", "70756-289-51", "70756-289-12", "70756-289-01", "70756-289-99", "72888-466-02", "72888-466-01", "0832-1054-90", "0832-1054-11", "0832-1054-15", "0832-1054-10", "0832-1055-90", "0832-1055-11", "0832-1055-15", "0832-1055-10", "72888-009-01", "72888-009-05", "72888-010-01", "72888-010-05", "72888-010-00", "72888-202-30", "72888-202-01", "72888-202-05", "72888-202-00", "72888-011-01", "72888-011-05", "72888-011-00", "70511-122-10", "70511-124-10", "59651-394-01", "59651-394-05", "59651-394-99", "59651-395-01", "59651-395-05", "59651-395-99", "72834-602-16", "0172-4096-60", "0172-4096-80", "0172-4097-60", "0172-4097-80", "52817-620-08", "69528-302-08", "69528-302-16", "16571-169-01", "16571-171-01", "16571-171-50", "16571-171-10", "16571-172-01", "16571-172-50", "16571-172-10", "25021-680-20", "25021-678-20", "25021-679-20", "62135-472-90", "62135-473-90", "62135-473-05", "62135-474-90", "62135-474-05", "71930-066-12", "71930-066-52", "71930-066-13", "71930-006-12", "71930-006-52", "71930-006-13", "71930-007-12", "71930-007-52", "71930-007-13", "0527-1330-01", "0527-1330-05", "0527-1330-10", "0527-1337-01", "0527-1337-05", "0527-1337-10", "0527-1333-01", "70511-121-06", "70511-121-83", "70511-121-80", "73352-103-16", "0603-2406-02", "0603-2406-21", "0603-2406-28", "0603-2406-32", "0603-2406-30", "0603-2407-21", "0603-2407-28", "0603-2407-32", "70511-123-20", "70710-1285-1", "70710-1285-5", "70710-1285-0", "70710-1286-1", "70710-1286-5", "70710-1286-0", "70710-1609-1", "70710-1666-1", "10135-532-01", "10135-532-05", "10135-532-10", "10135-533-01", "10135-533-05", "10135-533-10", "72865-296-01", "72865-297-01", "72865-297-05", "72865-297-10", "72865-298-01", "72865-298-05", "72865-298-10", "52652-6001-1", "52652-6001-2", "70771-1448-1", "70771-1448-5", "70771-1448-0", "70771-1449-1", "70771-1449-5", "70771-1449-0", "70771-1586-1", "70771-1868-1", "25021-681-71", "70512-782-10", "29300-474-01", "29300-343-19", "29300-343-01", "29300-343-05", "29300-343-10", "29300-344-19", "29300-344-01", "29300-344-05", "29300-344-10", "72888-145-36", "72888-146-36", "72888-147-36", "62559-204-12", "62559-204-03", "84386-035-01" ], "nui": [ "N0000000196", "N0000000116", "N0000175759" ], "pharm_class_moa": [ "GABA A Agonists [MoA]", "GABA B Agonists [MoA]" ], "pharm_class_epc": [ "gamma-Aminobutyric Acid-ergic Agonist [EPC]" ], "unii": [ "H789N3FKE8" ] } } ] } } ] }