{ "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": 1, "total": 1 } }, "results": [ { "safetyreportversion": "5", "safetyreportid": "15718723", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20220303", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20181213", "receiptdateformat": "102", "receiptdate": "20211004", "fulfillexpeditecriteria": "1", "companynumb": "US-UCBSA-2018054262", "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "0", "patientonsetageunit": "801", "patientweight": "2.3", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Renal aplasia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Hemivertebra", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Low birth weight baby", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Maternal exposure during pregnancy", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CERTOLIZUMAB PEGOL", "drugstructuredosagenumb": "200", "drugstructuredosageunit": "003", "drugdosagetext": "200 MG, 2X/MONTH", "drugdosageform": "Solution for injection", "drugadministrationroute": "064", "drugindication": "Rheumatoid arthritis", "drugstartdateformat": "102", "drugstartdate": "20180608", "drugenddateformat": "102", "drugenddate": "20190208", "drugtreatmentduration": "246", "drugtreatmentdurationunit": "804", "actiondrug": "1", "activesubstance": { "activesubstancename": "CERTOLIZUMAB PEGOL" }, "openfda": { "application_number": [ "BLA125160" ], "brand_name": [ "CIMZIA" ], "generic_name": [ "CERTOLIZUMAB PEGOL" ], "manufacturer_name": [ "UCB, Inc." ], "product_ndc": [ "50474-700", "50474-710", "50474-750" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "795081", "795085", "849597", "849599", "2724369", "2724370", "2724371", "2724372" ], "spl_id": [ "4b984e6f-72ac-4fdc-e063-6394a90af105" ], "spl_set_id": [ "b4c2c9dc-a0bb-4d64-a667-a67ebe88392d" ], "package_ndc": [ "50474-700-62", "50474-700-61", "50474-710-79", "50474-710-80", "50474-710-81", "50474-750-10" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "UMD07X179E" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "CERTOLIZUMAB PEGOL" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CALCIUM", "drugindication": "Product used for unknown indication", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "CALCIUM" }, "openfda": { "brand_name": [ "7030 CALCIUM PREMIUM", "AG-X", "7030 CALCIUM GOLD" ], "generic_name": [ "CALCIUM" ], "manufacturer_name": [ "Apexel Co., Ltd", "APEXEL CO., LTD." ], "product_ndc": [ "55259-1112", "55259-0007", "55259-0001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CALCIUM" ], "spl_id": [ "0fa8135f-89c9-41a2-e063-6294a90a403d", "11cc283a-fe2c-f101-e063-6294a90ad2d4", "11cc310a-d82e-be44-e063-6394a90a227c" ], "spl_set_id": [ "bdc7c833-daf7-48f9-e053-2995a90ad88e", "bdee5e24-645b-7fa0-e053-2995a90a7d25", "bdc7c088-83e3-20ce-e053-2995a90abd2f" ], "package_ndc": [ "55259-1112-1", "55259-0007-1", "55259-0001-1" ], "nui": [ "M0003153", "N0000175901" ], "pharm_class_cs": [ "Calcium [CS]" ], "pharm_class_epc": [ "Calcium [EPC]" ], "unii": [ "SY7Q814VUP" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CYMBALTA", "drugindication": "Fibromyalgia", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "DULOXETINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA021427" ], "brand_name": [ "CYMBALTA" ], "generic_name": [ "DULOXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-3235", "0002-3240", "0002-3270" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DULOXETINE HYDROCHLORIDE" ], "rxcui": [ "596926", "596928", "596930", "596932", "596934", "615186" ], "spl_id": [ "aa5061b1-f237-425a-9d05-575c333dfd37" ], "spl_set_id": [ "2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba" ], "package_ndc": [ "0002-3235-60", "0002-3240-30", "0002-3240-90", "0002-3270-30" ], "unii": [ "9044SC542W" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FLUCONAZOLE", "drugindication": "Fungal infection", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "FLUCONAZOLE" }, "openfda": { "application_number": [ "ANDA208963", "ANDA076658", "ANDA076665", "ANDA079104", "ANDA077731", "ANDA077253", "ANDA215738", "ANDA076766", "ANDA078764", "ANDA078698", "ANDA076736", "ANDA079150", "NDA020090", "ANDA078423" ], "brand_name": [ "FLUCONAZOLE", "DIFLUCAN" ], "generic_name": [ "FLUCONAZOLE" ], "manufacturer_name": [ "Zydus Lifesciences Limited", "Dr. Reddy's Laboratories Limited", "Chartwell RX, LLC", "Hospira, Inc", "Rising Pharma Holdings, Inc.", "Glenmark Pharmaceuticals Inc., USA", "Zhejiang Poly Pharm. Co., Ltd.", "Baxter Healthcare Company", "Hikma Pharmaceuticals USA Inc.", "NorthStar Rx LLC", "Sagent Pharmaceuticals", "BluePoint Laboratories", "Roerig", "Slate Run Pharmaceuticals", "Radha Pharmaceuticals Inc", "ANI Pharmaceuticals, Inc.", "Zydus Pharmaceuticals (USA) Inc.", "Mylan Pharmaceuticals Inc.", "Aurobindo Pharma Limited" ], "product_ndc": [ "70771-1063", "70771-1064", "70771-1065", "70771-1066", "55111-143", "55111-144", "55111-145", "55111-146", "62135-130", "62135-131", "62135-132", "62135-133", "0409-3435", "0409-4321", "57237-003", "57237-004", "57237-005", "57237-006", "68462-101", "68462-102", "68462-103", "68462-119", "68462-104", "72673-091", "0338-6045", "0338-6046", "0143-9666", "0143-9899", "0143-9669", "0143-9668", "0143-9667", "16714-691", "16714-694", "16714-692", "16714-693", "25021-184", "57237-149", "57237-150", "16714-695", "16714-696", "68001-251", "68001-253", "68001-254", "68001-252", "0049-3450", "0049-3410", "0049-3420", "0049-3500", "0049-3430", "0049-3440", "70436-227", "77771-396", "77771-397", "77771-398", "77771-399", "62559-990", "62559-991", "62559-992", "62559-993", "70710-1137", "70710-1138", "70710-1139", "70710-1140", "59762-5029", "59762-5015", "59762-5016", "59762-5017", "59762-5018", "59762-5030", "65862-299", "65862-300", "65862-058", "65862-059", "65862-060", "65862-061" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "FLUCONAZOLE" ], "rxcui": [ "197698", "197699", "197700", "197701", "1721314", "1721315", "310353", "310352", "201900", "201901", "207106", "207107", "207108", "207112" ], "spl_id": [ "4813fe26-a1f0-4782-a210-c669ae1ad899", "69e67aa4-a859-7ab0-79df-d9bf8489998d", "25892746-5194-5955-e063-6294a90a3b7f", "f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5", "1018b9ad-7145-49b4-903a-b483797d7c86", "639b832d-b798-4efb-8db0-e64b8ba81574", "47d8769c-b294-65ab-e063-6394a90a8bff", "36e35cdf-c4a0-428a-879e-1d65e2b66f64", "a90257a3-d842-4990-81a5-614293e23119", "06bbf63a-4457-4206-af05-246be0ddb301", "c643b54a-3aea-4b5a-afb9-fbb2917243fb", "8c4429e6-5542-4bec-9d50-1021ea548c01", "95e12350-efed-4dad-8ec3-6aa48fdc1512", "472a93c7-fd2a-f837-e063-6294a90aed1b", "c835d7dd-af65-4b2c-a92c-42d1986f902d", "2c3342fa-abe7-d6b0-e063-6394a90ad1c0", "bd560fcb-5efc-48d3-8d2c-e21f2d072215", "4616cc03-ba84-a659-e063-6294a90a7dcb", "eec2c521-a32a-482b-afb4-057860a109cf", "538304da-3971-4e3d-9ad3-af8b3dc186c3", "5a926244-1653-4a4e-9a60-9713a91d2485", "5305f9a9-119f-43e6-a48a-1598094d6c8f", "d017859b-48a2-4b16-9f5a-84316c6e7f4b" ], "spl_set_id": [ "0adb2f88-8a6f-4f33-9e2d-73f537e05313", "d7fa1d79-4cd3-4a55-b74b-b31e82e616a3", "f86ea347-78f5-43b8-9574-a52569a4237b", "22ebc3fb-ee81-44bd-a6e3-5e759ee724a8", "2ca7efcd-4a8d-4139-a3eb-930afd18b13f", "3da5f41d-5200-45ac-b89d-00881237ec85", "2a3ba181-5baa-5942-e063-6294a90a82b2", "cd24a261-9c15-42b4-8040-89d2dbda174e", "d3ca59bd-ae00-48ab-89aa-87c7f56e9989", "d2acccda-8068-46c1-8562-950d7f70ee06", "02f74fe7-0649-46c5-a06a-0700cd265773", "ccbe0991-27a1-4ddb-bfc7-1b3422e53390", "afde17e7-b95b-4cd5-97eb-e361724014bd", "83bcb8fc-53f1-4d7b-b083-0905b52c6c7e", "f694c617-3383-416c-91b6-b94fda371204", "13804efd-7cb3-431f-a6a7-bd6d1da5889e", "c041227b-dab6-4c29-ab59-d31993d524b2", "4616c7ad-be61-7ac0-e063-6394a90ab9ed", "8f90f169-6a72-4c33-a2af-0bc943602bc2", "d1364455-1537-46d4-b093-38cca3be778f", "737e0fac-a2d2-4053-a0d7-edbfb6248f69", "bf588f7e-89de-4b4e-8d33-c1ff2be1b34e", "6ebf24fd-41cd-4b3c-8176-a1436253ba2d" ], "package_ndc": [ "70771-1063-3", "70771-1063-1", "70771-1063-5", "70771-1063-4", "70771-1064-3", "70771-1064-1", "70771-1064-5", "70771-1064-4", "70771-1065-3", "70771-1065-1", "70771-1065-5", "70771-1065-7", "70771-1065-8", "70771-1066-3", "70771-1066-1", "70771-1066-5", "70771-1066-4", "55111-143-30", "55111-143-01", "55111-143-05", "55111-143-79", "55111-143-78", "55111-144-30", "55111-144-01", "55111-144-05", "55111-144-79", "55111-144-78", "55111-145-71", "55111-145-12", "55111-146-30", "55111-146-01", "55111-146-05", "55111-146-79", "55111-146-78", "62135-130-30", "62135-131-30", "62135-132-77", "62135-133-30", "0409-3435-01", "0409-3435-24", "0409-4321-01", "0409-4321-24", "57237-003-30", "57237-004-30", "57237-005-11", "57237-006-30", "57237-006-01", "68462-101-30", "68462-101-10", "68462-102-30", "68462-102-10", "68462-103-40", "68462-119-40", "68462-119-44", "68462-104-30", "68462-104-10", "72673-091-14", "0338-6046-48", "0338-6045-37", "0143-9899-01", "0143-9899-91", "0143-9669-01", "0143-9669-10", "0143-9668-01", "0143-9668-10", "0143-9667-01", "0143-9667-06", "0143-9666-01", "0143-9666-06", "16714-694-01", "16714-691-01", "16714-691-02", "16714-692-10", "16714-692-11", "16714-693-01", "16714-693-02", "25021-184-82", "25021-184-87", "57237-149-35", "57237-150-35", "16714-695-01", "16714-696-01", "68001-253-21", "68001-253-20", "68001-253-44", "68001-253-17", "68001-254-04", "68001-251-04", "68001-252-04", "0049-3410-30", "0049-3420-30", "0049-3420-41", "0049-3500-79", "0049-3430-30", "0049-3430-41", "0049-3440-19", "0049-3450-19", "70436-227-48", "25021-184-66", "25021-184-67", "77771-396-30", "77771-397-30", "77771-397-01", "77771-398-13", "77771-398-11", "77771-399-30", "77771-399-01", "62559-990-30", "62559-991-30", "62559-992-12", "62559-993-30", "70710-1137-1", "70710-1137-5", "70710-1137-4", "70710-1137-3", "70710-1138-3", "70710-1138-1", "70710-1138-5", "70710-1138-4", "70710-1139-3", "70710-1139-1", "70710-1139-5", "70710-1139-7", "70710-1139-8", "70710-1140-3", "70710-1140-1", "70710-1140-5", "70710-1140-4", "59762-5015-1", "59762-5016-1", "59762-5017-1", "59762-5018-1", "59762-5029-1", "59762-5030-1", "65862-299-35", "65862-300-35", "65862-058-30", "65862-059-30", "65862-059-01", "65862-059-05", "65862-060-11", "65862-061-30", "65862-061-01", "65862-061-05" ], "nui": [ "N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504" ], "pharm_class_epc": [ "Azole Antifungal [EPC]" ], "pharm_class_cs": [ "Azoles [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]" ], "unii": [ "8VZV102JFY" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FOLIC ACID", "drugindication": "Product used for unknown indication", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "FOLIC ACID" }, "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": "CANNABIDIOL", "drugindication": "Pain management", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "CANNABIDIOL" }, "openfda": { "application_number": [ "NDA210365" ], "brand_name": [ "EPIDIOLEX" ], "generic_name": [ "CANNABIDIOL" ], "manufacturer_name": [ "Jazz Pharmaceuticals, Inc." ], "product_ndc": [ "70127-100" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CANNABIDIOL" ], "rxcui": [ "2058900", "2058906" ], "spl_id": [ "1eb7ac65-8df5-4a4a-9156-802cfaa92b06" ], "spl_set_id": [ "8bf27097-4870-43fb-94f0-f3d0871d1eec" ], "package_ndc": [ "70127-100-01", "70127-100-10", "70127-100-06", "70127-100-60" ], "nui": [ "M0003267", "N0000187062", "N0000185504", "N0000182140", "N0000191278", "N0000191273", "N0000182138", "N0000182139", "N0000187064" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]", "UGT2B7 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]" ], "unii": [ "19GBJ60SN5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METHOTREXATE", "drugindication": "Rheumatoid arthritis", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "METHOTREXATE" }, "openfda": { "application_number": [ "ANDA210454", "NDA011719", "NDA212479", "ANDA040385", "ANDA040263", "ANDA220225", "ANDA040632", "ANDA201529", "ANDA201749", "ANDA081235", "NDA205776", "NDA208400", "ANDA040266", "ANDA040843", "ANDA207812", "ANDA081099", "ANDA040716", "ANDA089343", "ANDA089342", "ANDA089341", "ANDA089340", "ANDA213343", "ANDA217552", "NDA204824" ], "brand_name": [ "METHOTREXATE", "JYLAMVO", "TREXALL", "RASUVO", "XATMEP", "OTREXUP" ], "generic_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Chartwell RX, LLC", "Hospira, Inc.", "SHORLA ONCOLOGY INC.", "Teva Women's Health LLC", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Alembic Pharmaceuticals Limited", "Eugia US LLC", "Sun Pharmaceutical Industries, Inc.", "Mylan Pharmaceuticals Inc.", "Medexus Pharma Inc.", "Aurobindo Pharma Limited", "Azurity Pharmaceuticals, Inc.", "Teva Parenteral Medicines, Inc.", "Zydus Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc.", "Accord Healthcare, Inc.", "Zydus Lifesciences Limited", "Accord Healthcare Inc.", "Antares Pharma, Inc." ], "product_ndc": [ "62135-772", "61703-350", "61703-408", "81927-204", "51285-366", "51285-367", "51285-368", "51285-369", "63323-123", "62332-711", "62332-712", "0143-9830", "46708-711", "46708-712", "55150-510", "55150-511", "55150-512", "55150-513", "47335-235", "61703-124", "61703-161", "0378-0014", "0143-9367", "59137-505", "59137-510", "59137-515", "59137-520", "59137-525", "59137-530", "59137-535", "59137-540", "59137-550", "59651-182", "52652-2001", "63323-122", "0703-3671", "0703-3675", "0703-3678", "68382-775", "0555-0572", "16729-277", "0143-9516", "0143-9519", "0143-9518", "0143-9517", "70771-1058", "16729-486", "62332-730", "54436-010", "54436-075", "54436-012", "54436-015", "54436-017", "54436-020", "54436-022", "54436-025", "46708-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "INTRATHECAL", "INTRA-ARTERIAL" ], "substance_name": [ "METHOTREXATE SODIUM", "METHOTREXATE" ], "rxcui": [ "105585", "1655956", "1946772", "2671456", "2671462", "105586", "283510", "283511", "283671", "284592", "284593", "284594", "284595", "311625", "1655959", "1655960", "1655967", "1655968", "1441416", "1544378", "1544383", "1544385", "1544386", "1544387", "1544388", "1544389", "1544390", "1544394", "1544395", "1544396", "1544397", "1544398", "1544401", "1544402", "1544403", "1544404", "1921592", "1921598", "1441402", "1441407", "1441411", "1441413", "1441418", "1441422", "1441424", "1594757", "1594759", "1747179", "1747181", "1747185", "1747187", "1747192", "1747194" ], "spl_id": [ "462a5023-e5a1-692a-e063-6294a90a7236", "95b8b8da-da4e-4bba-9038-3cf65f3d5c1a", "37b3e76b-ac3d-4f93-adf1-91f52f676b8a", "53bd9776-70ec-46f9-e063-6294a90a7011", "d1e7432e-253d-49f0-ab0a-bb859210ccd6", "880c2caa-1b11-45ce-a54e-a3733da367f0", "91ce9c78-370f-49a1-ae22-428bdddb389f", "49eb25b2-c59c-4374-a216-076767fe1126", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "524f657e-d138-9c87-e063-6294a90a93ad", "6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "01ad6cb9-5879-4c06-801b-0de84eebaae7", "7950579c-084b-472b-a7ce-f342691aff97", "29d04017-dd64-4dea-a064-7b3b0805f423", "9fe03573-fff3-4051-8598-8542eee1273f", "4e3b0925-2cdc-4743-91cf-860d98dd4661", "3d21237a-ef53-4592-bf06-0c739696203d", "e81074cc-12b4-4ac9-a5bb-749188989b2c", "5d9b7269-19d4-4d2c-b252-f3ff759dffa5", "9c7cf5a6-e720-4e83-bb08-f371e9bb9c9e", "5aa89975-d1a1-19f1-e063-6294a90a4b3e", "3046ff78-3565-46d1-a88b-283e5ff6e7c3", "ae399908-cfb6-44dc-83da-8981f5dabbb8", "52d366f6-f339-ff1a-e063-6294a90a1577", "9dd138d6-6889-400e-a994-9931af68244a", "2d07eb50-d314-a6a0-e063-6394a90ac970", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "spl_set_id": [ "2609da8f-80dc-448e-8eba-35d11488ce7f", "0d63ba29-b692-41b4-87e8-351265c8273f", "0e30eaef-5a09-4104-8a11-c32933eadeab", "96e931f5-51ae-4bdf-a441-bb0dd26d4c0e", "e942f8db-510f-44d6-acb5-b822196f5e8c", "b585f621-f6c9-4735-ab61-bd1b401f3df0", "a63364d5-4dfa-49d7-8a5e-c8959ae1d37a", "b080eb92-fc72-4ce6-a7ab-3f9ce2415526", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "63bb6fbf-dd59-4edc-af8f-d0c397ca1262", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "bd287e89-32f9-4396-95fa-4b562869f476", "70c09984-2b36-424f-8b27-3fd0cd4e833d", "8593f7fc-eabe-44ae-bb05-b3d7d408e4f7", "d0075461-0e7e-4967-9c9b-d6440e912c0e", "09931d44-a3f8-49dc-a3f2-b527ee4214bf", "aec9984e-34c5-481b-b6bf-9bb5caf1daf8", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "346ec9ce-dc98-4a55-b55e-d3af11f2d703", "948e0bab-6524-4b87-9853-1799d4415558", "9b34b1d8-d125-41a2-9f6f-3fab67b573bd", "dd035a9f-cd40-4314-b9d8-2294b8a924e2", "3989d30d-56e5-4e8d-9379-c30fecc894f2", "59ea7b32-2b6d-4197-92c3-015936f04ebe", "874c7f43-a3be-4236-89cc-24c44e3c5813", "04a95db9-a124-4b97-bd71-1c37a6b3b0c8", "9ab8ce16-f7de-41d4-a4c8-1c742621b6d5", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "package_ndc": [ "62135-772-35", "61703-350-37", "61703-350-38", "61703-408-41", "61703-350-09", "61703-350-10", "61703-408-25", "81927-204-01", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "63323-123-10", "62332-711-01", "62332-711-05", "62332-712-01", "0143-9830-01", "46708-711-01", "46708-711-05", "46708-712-01", "55150-510-01", "55150-510-05", "55150-511-01", "55150-511-10", "55150-512-01", "55150-512-10", "55150-513-01", "47335-235-96", "47335-235-83", "61703-124-40", "61703-161-02", "61703-161-05", "0378-0014-01", "0143-9367-01", "59137-505-00", "59137-505-01", "59137-505-04", "59137-510-00", "59137-510-01", "59137-510-04", "59137-515-00", "59137-515-01", "59137-515-04", "59137-520-00", "59137-520-01", "59137-520-04", "59137-525-00", "59137-525-01", "59137-525-04", "59137-530-00", "59137-530-01", "59137-530-04", "59137-535-00", "59137-535-01", "59137-535-04", "59137-540-00", "59137-540-01", "59137-540-04", "59137-550-00", "59137-550-01", "59137-550-04", "59651-182-36", "59651-182-01", "52652-2001-1", "52652-2001-6", "63323-122-50", "0703-3671-01", "0703-3675-01", "0703-3678-01", "68382-775-60", "68382-775-16", "68382-775-01", "68382-775-05", "68382-775-10", "68382-775-77", "0555-0572-35", "0555-0572-02", "16729-277-30", "16729-277-03", "16729-277-35", "0143-9519-10", "0143-9518-01", "0143-9517-01", "0143-9516-01", "70771-1058-3", "70771-1058-9", "70771-1058-1", "70771-1058-5", "70771-1058-0", "70771-1058-2", "70771-1058-7", "16729-486-36", "16729-486-01", "62332-730-36", "62332-730-31", "54436-075-01", "54436-075-02", "54436-075-04", "54436-010-01", "54436-010-03", "54436-010-02", "54436-010-04", "54436-012-01", "54436-012-03", "54436-012-02", "54436-012-04", "54436-015-01", "54436-015-03", "54436-015-02", "54436-015-04", "54436-017-01", "54436-017-03", "54436-017-02", "54436-017-04", "54436-020-01", "54436-020-03", "54436-020-02", "54436-020-04", "54436-022-01", "54436-022-03", "54436-022-02", "54436-022-04", "54436-025-01", "54436-025-03", "54436-025-02", "54436-025-04", "46708-730-36", "46708-730-31" ], "unii": [ "3IG1E710ZN", "YL5FZ2Y5U1" ], "nui": [ "N0000175584", "N0000000111" ], "pharm_class_epc": [ "Folate Analog Metabolic Inhibitor [EPC]" ], "pharm_class_moa": [ "Folic Acid Metabolism Inhibitors [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "Vitamin d with omega 3", "drugindication": "Product used for unknown indication", "drugrecurreadministration": "3" }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE", "drugindication": "Rheumatoid arthritis", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "PREDNISONE" }, "openfda": { "application_number": [ "ANDA215246", "ANDA080292", "ANDA088832", "ANDA083677", "ANDA040584", "ANDA040581", "ANDA040256", "ANDA040392", "ANDA210785", "ANDA218035", "ANDA080352", "ANDA211495", "ANDA215671", "ANDA219477", "ANDA088703", "ANDA084275", "ANDA208412", "ANDA211496", "ANDA213385", "ANDA215672", "ANDA212629", "ANDA213386", "ANDA211575", "ANDA080356", "ANDA085162", "ANDA085161" ], "brand_name": [ "PREDNISONE", "PREDNISONE DELAYED RELEASE", "PREDNISONE TABLETS, USP, 5 MG", "PREDNISONE TABLETS, USP, 10 MG", "PREDNISONE TABLETS, USP, 20 MG" ], "generic_name": [ "PREDNISONE" ], "manufacturer_name": [ "ANI Pharmaceuticals, Inc.", "Mylan Pharmaceuticals Inc.", "Par Health USA, LLC", "Strides Pharma Science Limited", "Dr. Reddys Laboratories Inc.", "Hikma Pharmaceuticals USA Inc.", "Chartwell RX, LLC", "Aurobindo Pharma Limited", "INA Pharmaceutics Inc", "Amneal Pharmaceuticals NY LLC", "Granulation Technology, Inc.", "Actavis Pharma, Inc." ], "product_ndc": [ "70954-056", "0378-0640", "0378-0641", "0378-0642", "0603-5335", "0603-5336", "0603-5337", "0603-5338", "0603-5339", "64380-782", "43598-888", "0054-9817", "0054-9828", "0054-9818", "62135-471", "59651-484", "74157-010", "74157-019", "0054-0017", "0054-4741", "0054-4742", "0054-4728", "0054-0018", "0054-0019", "0054-3722", "0054-3721", "0054-8739", "0054-8740", "0054-8724", "62135-553", "64380-783", "64380-835", "62135-470", "60219-1705", "60219-1706", "59651-485", "59651-486", "59651-487", "59651-488", "59651-489", "43598-886", "43598-887", "64380-784", "64380-785", "64380-949", "63561-0120", "63561-0121", "63561-0122", "60219-1707", "60219-1708", "70954-057", "70954-058", "70954-059", "70954-060", "70954-061", "0591-5052", "0591-5442", "0591-5443" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISONE" ], "rxcui": [ "198144", "198145", "312615", "312617", "198146", "763179", "763181", "763183", "763185", "1303135", "1303125", "1303132", "198148", "205301", "315187" ], "spl_id": [ "08d9d724-eebf-4785-a0ac-95c049bc9488", "f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "68bdeba1-553d-4d18-ae66-5eb8a0a880b8", "675efef2-fa13-42d1-9460-d1e334f78a48", "1da2eb36-ff47-3cf6-e845-67460ced05fb", "249c4c6d-a058-489a-8f84-928c14bfd3f9", "45ae68aa-b969-3d1b-e063-6394a90a0a02", "6f9a9020-efd5-4f7d-90c7-11af33e93793", "463c5b39-7eb2-d396-e063-6394a90aa451", "523ad364-8d95-4679-9290-446d61f36eb5", "04b754a5-5740-f71c-e063-6294a90aef67", "c389b525-c68a-43dc-bacc-c75707b391b5", "45ae6dea-506e-55d8-e063-6394a90a0a4c", "abdf7308-9460-4e7f-a68a-2fe647e82602", "d957f055-4838-49e6-ae32-604fb3056bc4", "a9e0d98c-c1bf-62b0-67b3-3b8f8313b408", "bdf0b63b-7d6e-4799-be31-cdbf94e02145", "3c696af0-7946-dd78-e063-6394a90a71cc", "34381f6f-1b15-42c8-a8e6-af8302eb6c1e", "f662b658-7133-468c-b35a-ed6083cbff91", "6e6cf2e7-c839-4c9f-a58a-fea5023fb432" ], "spl_set_id": [ "7335a293-992b-490c-ab8a-66a7ca1eea30", "fec09050-5ac2-451b-a2b9-5a21b2def212", "10fe5a3b-84dc-4600-87c2-b80c97ce18cf", "a2c2e8ee-d222-47c5-93c2-8b44160a7e48", "474974ac-9811-c9f5-4050-58e535351d00", "263ed4fa-3c29-4abb-9cb1-bc016bd34a05", "36631112-3abb-4003-886b-9fe6d9cbe2cc", "7b33767f-a520-4470-8f3f-4e86b38d615a", "463c7cd2-c973-5c6c-e063-6394a90a09a0", "3115aef0-fd50-4ec8-a064-3effb695f3f2", "92483276-d55c-42c6-8bbc-27137ff25296", "52010a34-aadb-4561-ac4a-3ee53f5e3566", "f532c919-765d-407a-9e01-db2dc0c006f5", "0740ef68-7641-432e-bd46-4710687fc9d7", "b1ac4c92-e1fd-4015-b172-0932790ae019", "01bdc479-1f1f-af94-837c-12e7e861321a", "2ef05381-faad-4e0f-b58d-9f2236a04a2c", "a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "03228706-92b9-43c9-8d73-c73aa124c58d", "f05eb734-07e7-491c-b2e9-aae340e03750", "aa0b1582-6ef3-4697-9ea6-5391e6e57853" ], "package_ndc": [ "70954-056-10", "70954-056-20", "0378-0640-01", "0378-0640-10", "0378-0641-01", "0378-0641-10", "0378-0642-01", "0378-0642-05", "0378-0642-10", "0603-5335-21", "0603-5335-32", "0603-5336-21", "0603-5337-21", "0603-5337-32", "0603-5337-15", "0603-5337-31", "0603-5338-21", "0603-5338-28", "0603-5338-32", "0603-5338-15", "0603-5338-31", "0603-5339-21", "0603-5339-28", "0603-5339-32", "64380-782-06", "43598-888-01", "43598-888-30", "0054-9828-25", "0054-9828-31", "0054-9817-25", "0054-9817-29", "0054-9818-25", "0054-9818-29", "62135-471-90", "62135-471-18", "59651-484-01", "59651-484-99", "59651-484-78", "74157-010-30", "74157-019-30", "0054-4741-25", "0054-4741-31", "0054-4742-25", "0054-4728-25", "0054-4728-31", "0054-0017-25", "0054-0017-29", "0054-0017-20", "0054-0018-25", "0054-0018-29", "0054-0018-20", "0054-0019-20", "0054-0019-25", "0054-3722-63", "0054-3722-50", "0054-3721-44", "0054-8739-25", "0054-8740-25", "0054-8724-25", "62135-553-30", "62135-553-90", "64380-835-01", "64380-835-06", "64380-783-06", "64380-783-08", "64380-783-01", "62135-470-90", "62135-470-18", "60219-1705-1", "60219-1706-1", "60219-1706-7", "60219-1706-2", "60219-1706-3", "59651-485-01", "59651-485-78", "59651-486-01", "59651-486-99", "59651-486-78", "59651-487-01", "59651-487-05", "59651-487-78", "59651-488-01", "59651-488-05", "59651-488-78", "59651-489-01", "59651-489-78", "43598-886-01", "43598-886-30", "43598-887-01", "43598-887-30", "64380-784-01", "64380-784-07", "64380-784-08", "64380-784-06", "64380-785-06", "64380-785-07", "64380-785-08", "64380-785-01", "64380-949-06", "64380-949-01", "63561-0120-1", "63561-0120-2", "63561-0120-5", "63561-0121-1", "63561-0121-2", "63561-0121-5", "63561-0122-1", "63561-0122-2", "63561-0122-5", "60219-1707-1", "60219-1707-5", "60219-1707-2", "60219-1707-3", "60219-1708-1", "60219-1708-5", "70954-057-10", "70954-058-10", "70954-058-20", "70954-058-30", "70954-058-40", "70954-059-10", "70954-059-20", "70954-059-30", "70954-059-40", "70954-060-10", "70954-060-20", "70954-060-30", "70954-061-10", "0591-5052-01", "0591-5052-10", "0591-5052-21", "0591-5052-43", "0591-5442-01", "0591-5442-05", "0591-5442-10", "0591-5442-21", "0591-5442-43", "0591-5443-01", "0591-5443-05", "0591-5443-10" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "VB0R961HZT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL EXTRA STRENGTH", "drugindication": "Arthralgia", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "openfda": { "application_number": [ "M013" ], "brand_name": [ "TYLENOL EXTRA STRENGTH", "TYLENOL EXTRA STRENGTH CAPLET" ], "generic_name": [ "ACETAMINOPHEN" ], "manufacturer_name": [ "Kenvue Brands LLC", "Lil' Drug Store Products, Inc.", "Jones Healthcare Group - Packaging Services, Inc" ], "product_ndc": [ "50580-490", "50580-937", "50580-472", "50580-451", "50580-108", "50580-491", "66715-9747", "66715-6447", "66715-6547", "50580-378", "50580-469", "50580-209", "50580-590", "50580-692", "50580-187", "50580-488", "50580-457", "67414-449", "50580-449" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "198440", "209459", "198439", "351580", "2374360", "2374361", "307668", "828555" ], "spl_id": [ "4eda2e16-ed91-59d6-e063-6394a90abf72", "572fcd5f-40f6-eaf1-e063-6294a90a4143", "21c39261-4b98-bc43-e063-6394a90a4eb8", "2d87c8e1-e743-56cc-e063-6394a90aac79", "53536dcd-8f52-e352-e063-6294a90aa943", "4961695d-72f4-533a-e063-6294a90a5a29", "460387da-80ba-42ee-e063-6394a90a5957", "48dff3c9-329f-1300-e063-6294a90a47ef", "3bb7dcea-736b-343c-e063-6394a90a89e0", "3efe12ef-7f94-9548-e063-6294a90aba91", "22d94fd9-9488-a812-e063-6394a90a7ffc", "21c193b9-6b79-f35c-e063-6394a90adbfe", "423280b2-1f17-3a41-e063-6394a90a61e6", "4eda2608-4d48-1af0-e063-6294a90a2c72", "2ddb1260-fde6-1914-e063-6394a90a82d7", "39845b60-16e5-ee53-e063-6294a90af9d7", "5448d8a1-99d5-a698-e063-6294a90aff9b" ], "spl_set_id": [ "201b860d-dc3c-4380-affa-e757bf2103cf", "103d109d-f520-409c-8da2-eb6b0fbec891", "0c5fdda8-5049-46de-e063-6294a90a592b", "bb6533e5-e6a9-488c-b8ab-a6a06e87ede9", "3f653262-b931-7d42-e063-6394a90adddd", "4961695d-72f3-533a-e063-6294a90a5a29", "fa951d50-b79c-4161-8c81-fcf386b0964e", "17cfa99d-abb2-4d77-9e0e-e77109fbb61a", "3bb7dc60-97b2-1291-e063-6294a90a26d9", "ab02080a-c903-4e4a-a9f3-2b8197ed2f2b", "015a6179-bacb-452d-b594-4de628ddc11d", "dd87e342-b0cb-4111-9f15-415dbcda4b77", "42321456-d7dd-3b51-e063-6394a90ac292", "1b164780-ec84-4187-8afa-6f8a0da550fc", "c830320e-72ba-48ff-a4cd-250ac5650bf0", "fba711c1-4e69-49b0-8994-97c455aebcb2", "59773893-09a8-47a2-943a-e9ea9da4458a" ], "package_ndc": [ "50580-490-24", "50580-490-50", "50580-490-10", "50580-490-25", "50580-490-90", "50580-490-20", "50580-490-02", "50580-937-01", "50580-937-02", "50580-937-03", "50580-937-04", "50580-937-05", "50580-937-20", "50580-937-06", "50580-937-10", "50580-937-07", "50580-937-15", "50580-937-19", "50580-937-66", "50580-937-23", "50580-937-25", "50580-937-50", "50580-937-51", "50580-937-37", "50580-472-01", "50580-472-02", "50580-472-03", "50580-472-04", "50580-451-03", "50580-451-10", "50580-451-50", "50580-451-70", "50580-108-25", "50580-108-20", "50580-491-70", "50580-491-01", "50580-491-10", "66715-6447-2", "66715-6547-2", "66715-9747-1", "66715-9747-2", "66715-9747-3", "66715-9747-7", "66715-9747-8", "66715-9747-9", "50580-378-01", "50580-378-02", "50580-378-03", "50580-378-04", "50580-378-05", "50580-378-06", "50580-378-07", "50580-378-08", "50580-378-37", "50580-469-18", "50580-469-40", "50580-469-75", "50580-209-02", "50580-209-04", "50580-590-01", "50580-590-02", "50580-590-03", "50580-590-04", "50580-590-05", "50580-590-06", "50580-692-01", "50580-692-02", "50580-692-03", "50580-187-08", "50580-488-10", "50580-488-24", "50580-488-25", "50580-488-28", "50580-488-01", "50580-488-52", "50580-488-02", "50580-488-50", "50580-488-22", "50580-457-11", "50580-457-10", "50580-457-70", "67414-449-00", "67414-449-10", "67414-449-11", "50580-449-00", "50580-449-05", "50580-449-08", "50580-449-09", "50580-449-10", "50580-449-11", "50580-449-13", "50580-449-14", "50580-449-15", "50580-449-23", "50580-449-31", "50580-449-34", "50580-449-35", "50580-449-36", "50580-449-61", "50580-449-62", "50580-449-84", "50580-449-85", "50580-449-86", "50580-449-87", "50580-449-12", "50580-449-96", "50580-449-97", "50580-449-98", "50580-449-66", "50580-449-37" ], "unii": [ "362O9ITL9D" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL EXTRA STRENGTH", "drugindication": "Headache", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "openfda": { "application_number": [ "M013" ], "brand_name": [ "TYLENOL EXTRA STRENGTH", "TYLENOL EXTRA STRENGTH CAPLET" ], "generic_name": [ "ACETAMINOPHEN" ], "manufacturer_name": [ "Kenvue Brands LLC", "Lil' Drug Store Products, Inc.", "Jones Healthcare Group - Packaging Services, Inc" ], "product_ndc": [ "50580-490", "50580-937", "50580-472", "50580-451", "50580-108", "50580-491", "66715-9747", "66715-6447", "66715-6547", "50580-378", "50580-469", "50580-209", "50580-590", "50580-692", "50580-187", "50580-488", "50580-457", "67414-449", "50580-449" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "198440", "209459", "198439", "351580", "2374360", "2374361", "307668", "828555" ], "spl_id": [ "4eda2e16-ed91-59d6-e063-6394a90abf72", "572fcd5f-40f6-eaf1-e063-6294a90a4143", "21c39261-4b98-bc43-e063-6394a90a4eb8", "2d87c8e1-e743-56cc-e063-6394a90aac79", "53536dcd-8f52-e352-e063-6294a90aa943", "4961695d-72f4-533a-e063-6294a90a5a29", "460387da-80ba-42ee-e063-6394a90a5957", "48dff3c9-329f-1300-e063-6294a90a47ef", "3bb7dcea-736b-343c-e063-6394a90a89e0", "3efe12ef-7f94-9548-e063-6294a90aba91", "22d94fd9-9488-a812-e063-6394a90a7ffc", "21c193b9-6b79-f35c-e063-6394a90adbfe", "423280b2-1f17-3a41-e063-6394a90a61e6", "4eda2608-4d48-1af0-e063-6294a90a2c72", "2ddb1260-fde6-1914-e063-6394a90a82d7", "39845b60-16e5-ee53-e063-6294a90af9d7", "5448d8a1-99d5-a698-e063-6294a90aff9b" ], "spl_set_id": [ "201b860d-dc3c-4380-affa-e757bf2103cf", "103d109d-f520-409c-8da2-eb6b0fbec891", "0c5fdda8-5049-46de-e063-6294a90a592b", "bb6533e5-e6a9-488c-b8ab-a6a06e87ede9", "3f653262-b931-7d42-e063-6394a90adddd", "4961695d-72f3-533a-e063-6294a90a5a29", "fa951d50-b79c-4161-8c81-fcf386b0964e", "17cfa99d-abb2-4d77-9e0e-e77109fbb61a", "3bb7dc60-97b2-1291-e063-6294a90a26d9", "ab02080a-c903-4e4a-a9f3-2b8197ed2f2b", "015a6179-bacb-452d-b594-4de628ddc11d", "dd87e342-b0cb-4111-9f15-415dbcda4b77", "42321456-d7dd-3b51-e063-6394a90ac292", "1b164780-ec84-4187-8afa-6f8a0da550fc", "c830320e-72ba-48ff-a4cd-250ac5650bf0", "fba711c1-4e69-49b0-8994-97c455aebcb2", "59773893-09a8-47a2-943a-e9ea9da4458a" ], "package_ndc": [ "50580-490-24", "50580-490-50", "50580-490-10", "50580-490-25", "50580-490-90", "50580-490-20", "50580-490-02", "50580-937-01", "50580-937-02", "50580-937-03", "50580-937-04", "50580-937-05", "50580-937-20", "50580-937-06", "50580-937-10", "50580-937-07", "50580-937-15", "50580-937-19", "50580-937-66", "50580-937-23", "50580-937-25", "50580-937-50", "50580-937-51", "50580-937-37", "50580-472-01", "50580-472-02", "50580-472-03", "50580-472-04", "50580-451-03", "50580-451-10", "50580-451-50", "50580-451-70", "50580-108-25", "50580-108-20", "50580-491-70", "50580-491-01", "50580-491-10", "66715-6447-2", "66715-6547-2", "66715-9747-1", "66715-9747-2", "66715-9747-3", "66715-9747-7", "66715-9747-8", "66715-9747-9", "50580-378-01", "50580-378-02", "50580-378-03", "50580-378-04", "50580-378-05", "50580-378-06", "50580-378-07", "50580-378-08", "50580-378-37", "50580-469-18", "50580-469-40", "50580-469-75", "50580-209-02", "50580-209-04", "50580-590-01", "50580-590-02", "50580-590-03", "50580-590-04", "50580-590-05", "50580-590-06", "50580-692-01", "50580-692-02", "50580-692-03", "50580-187-08", "50580-488-10", "50580-488-24", "50580-488-25", "50580-488-28", "50580-488-01", "50580-488-52", "50580-488-02", "50580-488-50", "50580-488-22", "50580-457-11", "50580-457-10", "50580-457-70", "67414-449-00", "67414-449-10", "67414-449-11", "50580-449-00", "50580-449-05", "50580-449-08", "50580-449-09", "50580-449-10", "50580-449-11", "50580-449-13", "50580-449-14", "50580-449-15", "50580-449-23", "50580-449-31", "50580-449-34", "50580-449-35", "50580-449-36", "50580-449-61", "50580-449-62", "50580-449-84", "50580-449-85", "50580-449-86", "50580-449-87", "50580-449-12", "50580-449-96", "50580-449-97", "50580-449-98", "50580-449-66", "50580-449-37" ], "unii": [ "362O9ITL9D" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMINS", "drugindication": "Product used for unknown indication", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "VITAMINS" } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN B COMPLEX", "drugindication": "Product used for unknown indication", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "CYANOCOBALAMIN\\DEXPANTHENOL\\NIACINAMIDE\\PYRIDOXINE HYDROCHLORIDE\\RIBOFLAVIN 5^-PHOSPHATE SODIUM\\THIA" }, "openfda": { "brand_name": [ "VITAMIN B COMPLEX" ], "generic_name": [ "THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE" ], "manufacturer_name": [ "Mylan Institutional LLC" ], "product_ndc": [ "67457-146" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "THIAMINE HYDROCHLORIDE", "RIBOFLAVIN 5'-PHOSPHATE SODIUM", "DEXPANTHENOL", "NIACINAMIDE", "PYRIDOXINE HYDROCHLORIDE" ], "rxcui": [ "801177" ], "spl_id": [ "a7704aa3-bd3d-479e-8469-767d59636c7e" ], "spl_set_id": [ "282ccec8-9bcd-4571-9b91-bbb96ef2620d" ], "package_ndc": [ "67457-146-30" ], "unii": [ "M572600E5P", "20RD1DZH99", "1O6C93RI7Z", "25X51I8RD4", "68Y4CF58BV" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D", "drugindication": "Product used for unknown indication", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "VITAMIN D NOS" }, "openfda": { "application_number": [ "ANDA090455" ], "brand_name": [ "VITAMIN D" ], "generic_name": [ "ERGOCALCIFEROL" ], "manufacturer_name": [ "Strides Pharma Science Limited" ], "product_ndc": [ "64380-737" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ERGOCALCIFEROL" ], "rxcui": [ "1367410" ], "spl_id": [ "1cc589f7-cd6d-40a6-8fce-c965e8945eae" ], "spl_set_id": [ "2c4c0a36-12cf-444d-9d57-de983eef4d36" ], "package_ndc": [ "64380-737-06", "64380-737-25" ], "nui": [ "M0007651", "N0000175909" ], "pharm_class_cs": [ "Ergocalciferols [CS]" ], "pharm_class_epc": [ "Provitamin D2 Compound [EPC]" ], "unii": [ "VS041H42XC" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20180608" } } } ] }