{ "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": "1", "safetyreportid": "25423427", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20250717", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "1", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20250611", "receiptdateformat": "102", "receiptdate": "20250611", "fulfillexpeditecriteria": "1", "companynumb": "CA-TAKEDA-2025TUS053646", "primarysource": { "reportercountry": "CA", "qualification": "5" }, "sender": { "sendertype": "6", "senderorganization": "TAKEDA" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Seizure", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Skull fracture", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "28.0", "reactionmeddrapt": "Shoulder fracture", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugdosageform": "Powder for solution for infusion", "drugindication": "Crohn^s disease", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "1", "medicinalproduct": "VEDOLIZUMAB", "drugauthorizationnumb": "125476", "drugstructuredosagenumb": "108", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "2", "drugintervaldosagedefinition": "803", "drugdosagetext": "108 MILLIGRAM, Q2WEEKS", "drugdosageform": "Injection", "drugindication": "Crohn^s disease", "actiondrug": "4", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "VEDOLIZUMAB" }, "openfda": { "application_number": [ "BLA761133", "BLA125476" ], "brand_name": [ "ENTYVIO", "ENTYVIO PEN" ], "generic_name": [ "VEDOLIZUMAB" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "64764-107", "64764-300", "64764-108" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "INTRAVENOUS" ], "substance_name": [ "VEDOLIZUMAB" ], "rxcui": [ "1538137", "1538142", "2667332", "2667336", "2667339", "2667342" ], "spl_id": [ "266293d6-dd28-4e38-81c2-4f518d95ef5d" ], "spl_set_id": [ "6e94621c-1a95-4af9-98d1-52b9e6f1949c" ], "package_ndc": [ "64764-300-20", "64764-108-20", "64764-108-21", "64764-107-10", "64764-107-11" ], "nui": [ "N0000175775", "N0000175774" ], "pharm_class_epc": [ "Integrin Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Integrin Receptor Antagonists [MoA]" ], "unii": [ "9RV78Q2002" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN B12", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "CYANOCOBALAMIN" } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D3", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "025", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "CHOLECALCIFEROL" }, "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" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATORVASTATIN CALCIUM", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "ANDA205519", "ANDA091650", "ANDA209912", "ANDA213853", "ANDA217081", "NDA020702", "ANDA214344", "ANDA090548", "ANDA217118", "ANDA220276", "ANDA209288", "ANDA206536", "ANDA208480", "ANDA202357", "ANDA207687", "ANDA076477", "ANDA211933", "ANDA212103", "ANDA204991", "ANDA216436", "ANDA091226", "ANDA214659", "ANDA214513", "ANDA216848", "ANDA205300" ], "brand_name": [ "ATORVASTATIN CALCIUM", "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM", "ATORVASTATIN CALCIUM, FILM COATED" ], "manufacturer_name": [ "Cipla USA Inc.,", "Dr. Reddy's Laboratories Limited", "Rising Pharma Holdings, Inc.", "NIVAGEN PHARMACEUTICALS, INC.", "ScieGen Pharmaceuticals, Inc.", "NorthStar RxLLC", "Viatris Specialty LLC", "Quallent", "Umedica Laboratories USA Inc.", "Aurobindo Pharma Limited", "Teva Pharmaceuticals, Inc.", "Ascend Laboratories, LLC", "Zydus Lifesciences Limited", "Quallent Pharmaceuticals Health LLC", "Macleods Pharmaceuticals Limited", "Accord Healthcare Inc.", "Sun Pharmaceutical Industries Inc.", "Novadoz Pharmaceuticals LLC", "Cadila Pharmaceuticals Limited", "Lupin Pharmaceuticals, Inc.", "Apotex Corp.", "Biocon Pharma Inc.", "Radha Pharmaceuticals, Inc.", "Mylan Pharmaceuticals Inc.", "Lifestar Pharma LLC", "Dr. Reddy's Laboratories Inc", "NORTHSTAR RX LLC", "Laurus Labs Limited", "Lepu Pharmaceutical Technology Co., Ltd.", "Teva Pharmaceuticals USA, Inc.", "Camber Pharmaceuticals, Inc.", "Zydus Pharmaceuticals USA Inc." ], "product_ndc": [ "69097-897", "69097-944", "69097-898", "69097-945", "69097-899", "69097-946", "69097-911", "69097-947", "55111-121", "55111-122", "55111-123", "16571-136", "16571-137", "16571-138", "16571-139", "75834-255", "75834-256", "75834-257", "75834-258", "50228-451", "50228-452", "50228-453", "50228-454", "72603-403", "72603-404", "72603-405", "72603-406", "58151-155", "58151-156", "58151-157", "58151-158", "72603-282", "72603-283", "72603-284", "72603-285", "82009-001", "82009-002", "82009-003", "82009-004", "60290-039", "60290-040", "60290-041", "60290-042", "59651-606", "59651-607", "59651-608", "59651-609", "0480-3585", "0480-3586", "0480-3587", "0480-3588", "67877-511", "67877-512", "67877-513", "67877-514", "70771-1875", "70771-1876", "70771-1877", "70771-1878", "82009-176", "82009-178", "82009-177", "82009-179", "33342-315", "33342-316", "33342-317", "33342-318", "55111-124", "16729-044", "16729-045", "16729-046", "16729-047", "63304-829", "63304-828", "63304-827", "63304-830", "72205-022", "72205-023", "72205-024", "72205-025", "71209-090", "71209-091", "71209-092", "71209-093", "68180-635", "68180-636", "68180-637", "68180-638", "60505-2578", "60505-2579", "60505-2580", "60505-2671", "70377-077", "70377-078", "70377-079", "70377-080", "77771-451", "77771-452", "77771-453", "77771-454", "0378-3950", "0378-3951", "0378-3952", "0378-3953", "70756-247", "70756-248", "70756-249", "70756-250", "43598-830", "43598-831", "43598-832", "43598-833", "16714-173", "16714-174", "16714-175", "16714-176", "42385-940", "42385-941", "42385-942", "42385-943", "82137-016", "82137-017", "82137-018", "82137-019", "0093-5056", "0093-5059", "0093-5058", "0093-5057", "31722-424", "31722-425", "31722-426", "31722-427", "43598-098", "43598-099", "43598-101", "43598-103", "70710-1770", "70710-1777", "70710-1775", "70710-1772" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE", "ATORVASTATIN", "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE" ], "rxcui": [ "259255", "617310", "617311", "617312", "262095", "617314", "617318", "617320" ], "spl_id": [ "ee5777b3-1606-4a9c-b761-211b47d28522", "36e09eff-3948-2638-b633-d5ec2bc03d2a", "b94c6347-161c-44f2-8937-34c5098bf755", "4580fe3c-b524-3a14-e063-6294a90a34d3", "208c33d5-23fe-47aa-b855-02586fc6dd12", "e84506d1-dcd8-478c-ac0b-4328b0709494", "dd011a82-7356-4b83-86c4-b21cd9138fc6", "23198422-5895-dbbb-e063-6394a90a9474", "30b5cd59-2e05-be79-38bd-c81f157aa41d", "4999f880-cf37-837f-e063-6394a90a72d2", "b9128b7d-1e45-4f05-9f0a-26bd825e402d", "04eb61e3-d93f-4f90-ac12-92fc33bcfd8a", "777b866a-796a-4d15-8cb6-dd0c9a1856e2", "81d15801-dbb6-486a-9257-d80f6c3bc867", "3cc5dd82-b074-c0e2-e063-6394a90aa46e", "227d544e-2777-4da2-a626-65fa8d62209a", "3ec2bef7-b820-857f-1c70-e57c2d2c6dbf", "40828d2e-69eb-5d38-e063-6394a90abd70", "536bd509-870a-5525-e063-6294a90a86cf", "11823aa6-547f-4c0b-983a-65b837f94e89", "547579c7-a528-413f-b402-00f598775df3", "ab716c10-785b-4d43-a5f0-59f95b0b78c8", "68d09be6-1a04-4117-85dc-1d975e475c6a", "72b8b3f5-4658-80af-655c-87ce7966a5e6", "323762eb-66a3-4b6b-8e40-3374cc230a93", "113b06e8-1031-4e37-90d9-da72aa8c4f8d", "5a6b2543-e57d-418f-9156-d4aea7a917f1", "14581fb9-c75a-8300-dffc-732f7533a1ef", "ae4de6a7-ccde-a6fd-daaf-4a69151d89b7", "ba8208d7-c3b8-4ddc-8826-9f5265513bfa", "4257c559-499e-3a38-e063-6394a90aa0c9", "53f151e2-6323-4661-ad59-3c433c8ad1d4", "3afbe0e5-4ded-60ee-e063-6294a90a13a1", "d65dee47-02b6-c41f-923a-37bdbf701a54", "223716b7-8d87-4704-a08f-799e2cb5c29e" ], "spl_set_id": [ "18fe5990-399d-416c-852f-e14974317b8b", "901550e6-22be-68c9-eb86-f85a9c9dd998", "73cefb0b-1747-4fe0-b252-377f4ed94c6f", "7c58bf4a-4a92-4db8-89bc-4de1b5831efc", "f2d8b5e9-6ff2-4efa-ab01-e13df29f7371", "85fbaf22-017b-4163-b33e-c6594994859b", "a60cc18b-0631-4cf0-b021-9f52224ece65", "c1ba8fd9-aa40-466c-81bd-a87b364e9a1a", "f00a83aa-3f1d-566d-b9bb-f396f22a27cb", "5a7594ca-30be-4350-827f-ef745a2a7e18", "536b5e0d-1bb9-4c9d-a588-460d7647308b", "d3497ad6-b549-4144-b57f-b2088ad80b09", "67e60880-091a-4df7-8696-6e6c42a490e2", "06028adf-fcb5-452c-ba67-ee53bc65c519", "5b94b6f4-6f64-4551-abcb-8e845fb13813", "7bd0f0ec-f7a3-4403-9a1a-11f18213631f", "6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d", "4e06b20d-cc5d-46eb-991b-5972248de3af", "595ab888-6b55-4642-a32f-e8521821ed81", "bc448f40-421c-490f-8c39-fa8135507973", "51730b09-24e8-41c8-9fec-813f8a64b433", "a5767370-15a2-45e5-b980-7af9523aea7b", "d9adb9e4-c495-9530-e5e3-7e3b01d53e4c", "5b839619-1805-c227-91bf-182f5b966ba4", "10e766cc-c3fd-4584-a0d7-652c516e828c", "d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d", "de8f2c55-44d2-4e01-b7f2-dfb24f1f8760", "652f77a0-2145-896d-c760-e99e87507161", "52d8508b-aa98-cd89-5991-e2b5f982b6c6", "9f8ca507-b784-4d18-8d3e-d7d68072c416", "173474b6-26b4-46f2-a12a-64753ae5e905", "86841382-4229-4e03-958e-3ac22639efd4", "25c8f92f-9cb6-482b-82e1-16ad7c94e7b3", "aaf960d1-8bf9-64c6-1e70-8aa33b0ce549", "55ad4a90-d177-4cce-b7ec-cb75067f6c14" ], "package_ndc": [ "69097-897-05", "69097-897-15", "69097-944-05", "69097-944-15", "69097-898-05", "69097-898-12", "69097-945-05", "69097-945-12", "69097-899-05", "69097-899-15", "69097-946-05", "69097-946-15", "69097-911-05", "69097-911-12", "69097-947-05", "69097-947-12", "55111-121-30", "55111-121-60", "55111-121-90", "55111-121-05", "55111-121-10", "55111-122-30", "55111-122-60", "55111-122-90", "55111-122-05", "55111-122-10", "55111-123-30", "55111-123-60", "55111-123-90", "55111-123-05", "55111-123-10", "16571-136-09", "16571-136-50", "16571-136-10", "16571-137-09", "16571-137-50", "16571-137-10", "16571-138-09", "16571-138-50", "16571-138-10", "16571-139-09", "16571-139-50", "16571-139-10", "75834-256-90", "75834-256-01", "75834-256-05", "75834-256-50", "75834-255-90", "75834-255-01", "75834-255-05", "75834-255-50", "75834-257-90", "75834-257-50", "75834-257-25", "75834-257-01", "75834-258-90", "75834-258-50", "75834-258-02", "75834-258-01", "50228-451-90", "50228-451-10", "50228-452-90", "50228-452-05", "50228-453-90", "50228-453-10", "50228-454-90", "50228-454-05", "72603-403-01", "72603-403-02", "72603-404-01", "72603-404-02", "72603-405-01", "72603-405-02", "72603-406-01", "72603-406-02", "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77", "72603-282-01", "72603-282-02", "72603-282-03", "72603-283-01", "72603-283-02", "72603-283-03", "72603-284-01", "72603-284-02", "72603-284-03", "72603-285-01", "72603-285-02", "72603-285-03", "82009-001-90", "82009-001-10", "82009-002-10", "82009-003-10", "82009-004-10", "60290-039-01", "60290-039-02", "60290-039-03", "60290-039-04", "60290-040-01", "60290-040-02", "60290-040-03", "60290-040-04", "60290-041-01", "60290-041-02", "60290-041-03", "60290-041-04", "60290-042-01", "60290-042-02", "60290-042-03", "60290-042-04", "59651-606-30", "59651-606-90", "59651-606-05", "59651-606-99", "59651-607-30", "59651-607-90", "59651-607-05", "59651-607-99", "59651-608-30", "59651-608-90", "59651-608-05", "59651-608-99", "59651-609-30", "59651-609-90", "59651-609-05", "59651-609-99", "0480-3585-98", "0480-3585-10", "0480-3586-98", "0480-3586-10", "0480-3587-98", "0480-3587-10", "0480-3588-98", "0480-3588-10", "67877-511-90", "67877-511-05", "67877-511-10", "67877-511-55", "67877-511-33", "67877-511-38", "67877-512-90", "67877-512-05", "67877-512-10", "67877-512-44", "67877-512-33", "67877-512-38", "67877-513-90", "67877-513-05", "67877-513-10", "67877-513-23", "67877-513-33", "67877-513-38", "67877-514-90", "67877-514-05", "67877-514-10", "67877-514-33", "67877-514-38", "70771-1875-9", "70771-1875-5", "70771-1875-0", "70771-1876-9", "70771-1876-5", "70771-1876-0", "70771-1877-9", "70771-1877-5", "70771-1877-0", "70771-1878-9", "70771-1878-5", "70771-1878-0", "82009-178-10", "82009-176-10", "82009-177-10", "82009-179-10", "33342-315-10", "33342-315-15", "33342-315-12", "33342-315-11", "33342-315-44", "33342-316-10", "33342-316-15", "33342-316-12", "33342-316-11", "33342-316-44", "33342-317-10", "33342-317-15", "33342-317-12", "33342-317-11", "33342-317-44", "33342-318-10", "33342-318-15", "33342-318-12", "33342-318-11", "33342-318-44", "55111-124-30", "55111-124-60", "55111-124-90", "55111-124-05", "16729-045-10", "16729-045-15", "16729-045-01", "16729-045-16", "16729-045-17", "16729-044-10", "16729-044-15", "16729-044-01", "16729-044-16", "16729-044-17", "16729-046-10", "16729-046-15", "16729-046-01", "16729-046-16", "16729-046-17", "16729-047-10", "16729-047-15", "16729-047-01", "16729-047-16", "16729-047-17", "63304-828-90", "63304-828-05", "63304-827-90", "63304-827-05", "63304-829-90", "63304-829-05", "63304-830-90", "63304-830-05", "72205-022-30", "72205-022-90", "72205-022-05", "72205-022-99", "72205-023-30", "72205-023-90", "72205-023-05", "72205-023-99", "72205-024-30", "72205-024-90", "72205-024-05", "72205-024-99", "72205-025-30", "72205-025-90", "72205-025-05", "72205-025-99", "71209-090-04", "71209-091-04", "71209-092-04", "71209-092-10", "71209-093-04", "71209-093-10", "68180-635-02", "68180-635-09", "68180-635-06", "68180-636-02", "68180-636-09", "68180-636-06", "68180-637-02", "68180-637-09", "68180-637-06", "68180-638-02", "68180-638-09", "68180-638-06", "60505-2578-3", "60505-2578-9", "60505-2578-5", "60505-2578-8", "60505-2578-7", "60505-2578-0", "60505-2579-3", "60505-2579-9", "60505-2579-5", "60505-2579-8", "60505-2579-7", "60505-2579-0", "60505-2580-3", "60505-2580-9", "60505-2580-5", "60505-2580-8", "60505-2580-7", "60505-2580-0", "60505-2671-3", "60505-2671-9", "60505-2671-5", "60505-2671-8", "60505-2671-7", "60505-2671-0", "70377-077-11", "70377-077-13", "70377-077-12", "70377-078-11", "70377-078-13", "70377-078-12", "70377-079-11", "70377-079-12", "70377-079-13", "70377-080-11", "70377-080-12", "70377-080-13", "77771-452-90", "77771-452-05", "77771-453-90", "77771-453-10", "77771-454-90", "77771-454-05", "77771-451-90", "77771-451-10", "0378-3950-77", "0378-3950-05", "0378-3950-09", "0378-3950-07", "0378-3951-77", "0378-3951-05", "0378-3951-09", "0378-3951-07", "0378-3952-77", "0378-3952-05", "0378-3952-09", "0378-3952-07", "0378-3953-77", "0378-3953-05", "0378-3953-09", "0378-3953-07", "70756-247-30", "70756-247-90", "70756-247-51", "70756-247-12", "70756-248-90", "70756-248-51", "70756-248-12", "70756-248-30", "70756-249-30", "70756-249-90", "70756-249-51", "70756-249-12", "70756-250-30", "70756-250-90", "70756-250-51", "43598-830-90", "43598-830-05", "43598-830-79", "43598-830-78", "43598-831-90", "43598-831-05", "43598-831-79", "43598-831-78", "43598-832-90", "43598-832-05", "43598-832-79", "43598-832-78", "43598-833-90", "43598-833-05", "43598-833-79", "43598-833-81", "16714-173-01", "16714-173-02", "16714-173-03", "16714-174-01", "16714-174-02", "16714-174-03", "16714-175-01", "16714-175-02", "16714-175-03", "16714-176-01", "16714-176-02", "16714-176-03", "42385-940-30", "42385-940-90", "42385-940-01", "42385-940-05", "42385-940-11", "42385-940-10", "42385-940-68", "42385-941-30", "42385-941-90", "42385-941-01", "42385-941-05", "42385-941-11", "42385-941-10", "42385-941-68", "42385-942-30", "42385-942-90", "42385-942-01", "42385-942-05", "42385-942-11", "42385-942-10", "42385-942-68", "42385-943-30", "42385-943-90", "42385-943-01", "42385-943-05", "42385-943-11", "42385-943-08", "42385-943-64", "42385-943-10", "42385-943-68", "82137-016-01", "82137-017-01", "82137-018-01", "82137-019-01", "0093-5056-98", "0093-5056-10", "0093-5059-98", "0093-5059-10", "0093-5058-98", "0093-5058-10", "0093-5057-98", "0093-5057-05", "31722-424-90", "31722-424-10", "31722-424-05", "31722-425-90", "31722-425-10", "31722-425-05", "31722-426-90", "31722-426-05", "31722-426-10", "31722-427-90", "31722-427-05", "31722-427-10", "43598-098-90", "43598-098-05", "43598-098-10", "43598-098-78", "43598-098-87", "43598-099-90", "43598-099-05", "43598-099-87", "43598-099-10", "43598-099-78", "43598-101-90", "43598-101-05", "43598-101-87", "43598-101-10", "43598-101-78", "43598-103-90", "43598-103-05", "43598-103-87", "43598-103-10", "43598-103-81", "70710-1777-9", "70710-1777-5", "70710-1777-0", "70710-1775-9", "70710-1775-5", "70710-1775-0", "70710-1772-9", "70710-1772-5", "70710-1772-0", "70710-1770-9", "70710-1770-5", "70710-1770-0" ], "unii": [ "48A5M73Z4Q", "A0JWA85V8F", "YRZ789OWMI" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TRAZODONE", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "TRAZODONE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "ENTOCORT", "drugstructuredosagenumb": "3", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "BUDESONIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "ENTOCORT", "drugstructuredosagenumb": "9", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "9 MILLIGRAM, QD", "drugstartdateformat": "610", "drugstartdate": "202411", "activesubstance": { "activesubstancename": "BUDESONIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "PANTOPRAZOLE MAGNESIUM", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "PANTOPRAZOLE MAGNESIUM" } }, { "drugcharacterization": "2", "medicinalproduct": "ESCITALOPRAM OXALATE", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "ESCITALOPRAM OXALATE" }, "openfda": { "application_number": [ "ANDA090432", "ANDA202221", "ANDA090939", "ANDA079062", "ANDA078604", "ANDA202227", "ANDA205619", "ANDA215177", "ANDA202210", "ANDA202280", "ANDA079121" ], "brand_name": [ "ESCITALOPRAM", "ESCITALOPRAM OXALATE" ], "generic_name": [ "ESCITALOPRAM OXALATE", "ESCITALOPRAM" ], "manufacturer_name": [ "Aurobindo Pharma Limited", "Camber Pharmaceuticals, Inc.", "Quallent Pharmaceuticals Health LLC", "Rising Pharma Holdings, Inc.", "Exelan Pharmaceuticals Inc.", "Amneal Pharmaceuticals LLC", "Ascent Pharmaceuticals, Inc", "Amneal Pharmaceuticals of New York LLC", "Macleods Pharmaceuticals Limited", "Cipla USA Inc.", "Jubilant Cadista Pharmaceuticals Inc.", "Sun Pharmaceutical Industries, Inc.", "NorthStar RxLLC" ], "product_ndc": [ "65862-373", "65862-374", "65862-375", "31722-569", "82009-035", "82009-036", "82009-037", "16571-769", "65862-248", "76282-249", "76282-250", "76282-251", "65162-705", "65162-019", "65162-020", "65162-021", "43602-473", "43602-474", "43602-475", "53746-019", "53746-020", "53746-021", "33342-036", "33342-037", "33342-038", "69097-847", "69097-848", "69097-849", "59746-279", "59746-280", "59746-281", "51672-1348", "72603-149", "72603-150", "72603-151" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESCITALOPRAM OXALATE" ], "rxcui": [ "349332", "351249", "351250", "351285" ], "spl_id": [ "eee33c81-29aa-4666-af3b-fef9c3de6107", "529ec25b-d886-6690-e063-6394a90a2ad3", "8535cead-aff5-4a22-b788-1d5926e02097", "b7140557-3cc1-4c7a-952f-2dca7ae2e9d3", "a8ce07ef-c51d-4af2-bafb-b0a32c090431", "787c121b-d227-4f2f-aa8d-e2dd69790fa6", "d29f980a-e696-4020-8bf9-8f81016c0699", "058fe58a-fa86-459a-b79a-ac337913bc7e", "c891ea0b-ed9d-4e75-a529-2b8a651034d2", "fe4fad91-a1c2-41f2-933d-94bdfb86d38c", "53210109-53db-4d08-8ea4-be60e5597caf", "7e44336f-9692-42ff-af45-f98edd0c803c", "a76a9a9c-0066-4250-9f8e-d5ba78529ed4", "38e51a59-5806-77a6-e063-6394a90af6c6", "cb888b2f-8092-43a1-8542-a10e2b004369" ], "spl_set_id": [ "d5fbc8ce-bd41-4bd0-b413-0dea97e596c3", "82d793ee-4039-45fc-ac83-4bd5235f00aa", "d8e22060-4d06-42bf-a881-caaf65ecc3e3", "79fddc2d-2dc2-444f-8fd3-0337090ee744", "ba60c357-8e61-4a3d-b1dc-25602dbbfc2a", "8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2", "09894a38-4e3a-475d-96cd-c6c8ed87869a", "8704d062-fa91-4224-9dec-41664d20ee6b", "1285841d-d9f8-49c6-9456-bf51c8e37271", "4f941d7a-5abb-4907-a7a1-480245deef87", "24b43cb4-1a26-44a2-b1d8-a40239eb5c7c", "31ce0b82-58fe-44f3-8887-c55d8df1b773", "2db02476-325f-ee47-a7e5-b5aed56c364c", "c871d3fe-5ca2-410c-976d-9ec4b72c878f", "81840aec-96fd-4af2-bd10-3f38d068f39a" ], "package_ndc": [ "65862-373-30", "65862-373-90", "65862-373-01", "65862-373-05", "65862-373-19", "65862-373-10", "65862-374-30", "65862-374-90", "65862-374-01", "65862-374-05", "65862-374-59", "65862-374-10", "65862-375-30", "65862-375-90", "65862-375-01", "65862-375-05", "65862-375-39", "65862-375-10", "31722-569-24", "82009-035-10", "82009-036-10", "82009-037-10", "16571-769-24", "65862-248-24", "76282-249-30", "76282-249-90", "76282-249-01", "76282-249-05", "76282-249-10", "76282-250-30", "76282-250-90", "76282-250-01", "76282-250-05", "76282-250-10", "76282-251-30", "76282-251-90", "76282-251-01", "76282-251-05", "76282-251-10", "65162-705-88", "65162-019-03", "65162-019-09", "65162-019-50", "65162-019-11", "65162-020-03", "65162-020-09", "65162-020-50", "65162-020-11", "65162-021-03", "65162-021-09", "65162-021-50", "65162-021-11", "43602-473-30", "43602-473-10", "43602-474-30", "43602-474-10", "43602-475-30", "43602-475-10", "53746-019-30", "53746-019-90", "53746-019-05", "53746-019-10", "53746-020-30", "53746-020-90", "53746-020-05", "53746-020-10", "53746-021-30", "53746-021-90", "53746-021-05", "53746-021-10", "33342-036-11", "33342-036-12", "33342-036-15", "33342-037-11", "33342-037-12", "33342-037-15", "33342-038-11", "33342-038-12", "33342-038-15", "69097-847-02", "69097-847-05", "69097-847-07", "69097-847-12", "69097-847-15", "69097-848-02", "69097-848-05", "69097-848-07", "69097-848-12", "69097-848-15", "69097-849-02", "69097-849-05", "69097-849-07", "69097-849-12", "69097-849-15", "59746-279-30", "59746-279-01", "59746-279-05", "59746-279-10", "59746-280-30", "59746-280-01", "59746-280-05", "59746-280-10", "59746-281-30", "59746-281-01", "59746-281-05", "59746-281-10", "59746-281-90", "51672-1348-8", "51672-1348-1", "51672-1348-9", "72603-149-01", "72603-150-01", "72603-151-01" ], "unii": [ "5U85DBW7LO" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NABILONE", "drugstructuredosagenumb": "0.25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "activesubstance": { "activesubstancename": "NABILONE" }, "openfda": { "application_number": [ "NDA018677" ], "brand_name": [ "CESAMET" ], "generic_name": [ "NABILONE" ], "manufacturer_name": [ "Bausch Health US LLC" ], "product_ndc": [ "0187-1231" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NABILONE" ], "rxcui": [ "104885", "311891" ], "spl_id": [ "c8ba6520-445a-4934-85f4-6f706cb21585" ], "spl_set_id": [ "83c7ac15-ece9-47de-b83c-d575544fa449" ], "package_ndc": [ "0187-1231-50" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "2N4O9L084N" ] } }, { "drugcharacterization": "2", "medicinalproduct": "BUDESONIDE", "drugstructuredosagenumb": "9", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "9 MILLIGRAM, QD", "drugstartdateformat": "610", "drugstartdate": "202411", "activesubstance": { "activesubstancename": "BUDESONIDE" }, "openfda": { "application_number": [ "ANDA078949", "NDA203634", "ANDA211922", "NDA205613", "ANDA078202", "NDA213976", "ANDA204548", "ANDA206200", "NDA020929", "ANDA205457", "NDA215935", "ANDA206134", "NDA021949", "ANDA077519", "ANDA205710", "ANDA078404", "ANDA208851", "ANDA215328", "ANDA216667", "NDA021324" ], "brand_name": [ "BUDESONIDE", "EOHILIA", "PULMICORT RESPULES", "TARPEYO", "UCERIS", "PULMICORT FLEXHALER", "BUDESONIDE INHALATION SUSPENSION", "BUDESONIDE INHALATION" ], "generic_name": [ "BUDESONIDE" ], "manufacturer_name": [ "Walgreens", "Rugby Laboratories", "Oceanside Pharmaceuticals", "Sun Pharmaceutical Industries, Inc.", "Chartwell RX, LLC", "TAKEDA PHARMACEUTICALS AMERICA, INC.", "Teva Pharmaceuticals USA, Inc.", "Amneal Pharmaceuticals of New York LLC", "AstraZeneca Pharmaceuticals LP", "Actavis Pharma, Inc.", "Calliditas Therapeutics AB", "Apotex Corp.", "Zydus Pharmaceuticals USA Inc.", "Salix Pharmaceuticals, Inc.", "H2-Pharma LLC", "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "Zydus Lifesciences Limited", "Rising Pharma Holdings, Inc.", "CVS Pharmacy", "Cipla USA Inc.", "Exelan Pharmaceuticals, Inc.", "Santarus Inc.", "Northstar Rx LLC.", "Mylan Pharmaceuticals Inc.", "Padagis Israel Pharmaceuticals Ltd", "Aurobindo Pharma Limited", "Amneal Pharmaceuticals LLC", "Nephron Pharmaceuticals Corporation", "Padagis US LLC", "Rubicon Holdings Inc." ], "product_ndc": [ "0363-0048", "0536-1456", "68682-309", "47335-631", "47335-632", "47335-633", "68682-658", "62135-822", "62135-823", "64764-105", "0093-6817", "53746-778", "0186-1988", "0186-1989", "0186-1990", "0591-2510", "81749-004", "60505-6129", "68382-720", "65649-651", "61269-509", "61269-518", "0093-6815", "0093-6816", "49035-703", "70771-1075", "0536-1112", "64980-638", "64980-639", "69842-001", "69097-318", "69097-319", "69097-321", "76282-640", "76282-641", "76282-642", "68012-309", "0115-1687", "0115-1689", "16714-829", "0378-4500", "45802-627", "59651-585", "65162-778", "0487-9601", "0487-9701", "0574-9855", "85612-010", "85612-011" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "NASAL", "ORAL", "RESPIRATORY (INHALATION)", "RECTAL" ], "substance_name": [ "BUDESONIDE" ], "rxcui": [ "1797929", "1366550", "252559", "349094", "351109", "1596779", "2675280", "2675286", "1244214", "616817", "616819", "616830", "2587883", "2587889", "1596778", "966522", "966524", "966527", "966529", "1366556" ], "spl_id": [ "aa57e2f5-f2ba-4341-bb6c-5d664756478a", "5592d8c7-a130-4ec6-8b15-9329daeb91c7", "2553124a-3ed4-365d-e063-6294a90a4224", "c5265800-f7ea-4258-8555-5465104858a0", "cfc0acf9-28d8-4404-81ec-c832914d2ea6", "10690463-7fb3-af77-e063-6294a90ad2de", "6b8f012a-d7af-4200-a5b8-5a56f6962ccd", "e505244f-d53f-4dc0-acd7-45dc98034b97", "6c4112fe-354a-472f-97ba-fa86d405b7f7", "76a8044c-b6f4-4da4-b855-a281fdca66b4", "5b1c0fe2-b58d-43b4-8784-038653663c44", "48e9b876-94c8-7c9f-e063-6294a90adcef", "df59479a-8980-e041-8936-c4fb5926ef88", "08f8aa4f-4543-46d3-91f7-ae943f455648", "205783ee-5004-4fcb-a9d6-ce1ac824357c", "f6ce08aa-a011-4120-a609-d542a4db8c15", "551a929a-3517-4e58-9df6-f9bfb0f2f3be", "fce82ec5-1379-4faa-a710-f989c6c9ca5a", "bfde9c2e-2ff5-4258-91bc-78a48b228d14", "ce26c1bb-c50d-7731-6877-0b8a5fda98df", "56c0116d-714d-2f59-e063-6294a90a5d10", "e78eb875-a802-43b8-8672-cbde17e9b607", "29644146-4bcf-49d0-80b3-e31f4b3a6f54", "c53a81a4-fad8-4587-ac13-cc4de968485e", "250346dc-e6de-b148-e063-6394a90a1ca3", "dbb6c949-66b1-4f60-ab96-442dd8b4ea19", "1780fdb2-9492-4cec-840e-923f19561188", "812acf8d-0936-4ba9-9952-ae9f2266649b", "c51e584e-be7e-4807-aa09-ef3eca459a2f", "ad4a68e7-9200-4f05-8058-714d5d8900f8", "c70c734f-2431-4414-bb94-4adda4985e5d", "ef5a72fa-15a8-427d-83c5-74190a22ecd3", "32635b5d-cc62-710c-e063-6294a90a2802", "d502ff68-2ba4-461c-a739-9012f4f09dec", "3dff07f9-e653-e2a1-e063-6294a90a92ff" ], "spl_set_id": [ "9d519bf3-8d9b-5208-13c5-308edc24aca7", "b83af99e-1619-48ed-a033-e5207033f77e", "a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1", "a39fbcfc-3ffd-44bd-b882-01f8e1844213", "b2cf85c5-3ae0-4f91-9f3a-1d6771e14a73", "374013c9-18c9-4419-b9fb-9bc5c765688e", "56f2023a-69b2-4470-b4ad-af7ec1be527a", "d90ffda1-12c7-4726-90e9-64bb103e84b5", "10336e42-0e9d-45c4-80bc-5149d5ec9e1c", "33cd9834-76df-4f26-3fa2-aab6b9eee8f2", "41d4fd39-81ee-41be-b34d-efb12b3a359d", "938cada4-d6bf-4252-836f-dd40f9eadb4d", "f1aac35a-bc72-dd68-8179-8661354589cb", "29863154-5f98-410e-9bf3-0f08b551edef", "230e4596-2a9b-4d55-b0a0-0cabbcff5289", "10f2ae5b-a6fb-4804-9111-0cd067c2b1b2", "4f126a29-38f7-4c4c-8978-37e72b289902", "d9ba3859-90af-0390-11be-c04834e27d61", "d645a346-c99b-4de7-9bca-69e73266d6b4", "04eb9e98-1323-353f-3fd7-2d317dfac526", "3235e2a4-8e12-2d58-e063-6294a90a4936", "b2650d29-c011-48f1-a7f4-040011d4563d", "c52c5382-1400-44b9-95be-a30e1cf706da", "d9656442-4587-4867-9a8c-5f5b0402936e", "92cbb190-8851-46ed-bfe0-166ca62ef2e9", "e8ef9489-83a2-4817-b21c-ea3fecd8c8dd", "a37866df-df07-4f71-8591-98c2804c4794", "f7265276-e649-4bc4-8ac8-1f5ac2b984e8", "2414058b-5d39-42f2-915f-03a5e1101ab5", "ad4a68e7-9200-4f05-8058-714d5d8900f8", "c70c734f-2431-4414-bb94-4adda4985e5d", "b15102d5-7884-44ed-8340-046d7b516fa8", "f12043df-f9a3-4edb-88f8-dd176c1a141c", "3a18d5a7-04c5-4137-8155-70a8adc0a48b", "ae1105cd-69fc-4c15-937f-c535304341c2" ], "package_ndc": [ "0363-0048-01", "0536-1456-84", "68682-309-30", "47335-631-48", "47335-631-49", "47335-632-48", "47335-632-49", "47335-633-48", "47335-633-49", "68682-658-02", "68682-658-03", "62135-822-84", "62135-823-84", "64764-105-10", "64764-105-60", "64764-105-01", "64764-105-00", "0093-6817-19", "0093-6817-45", "0093-6817-73", "53746-778-10", "0186-1988-04", "0186-1989-04", "0186-1990-04", "0591-2510-30", "81749-004-01", "60505-6129-2", "60505-6129-7", "60505-6129-6", "68382-720-06", "68382-720-16", "68382-720-01", "68382-720-05", "68382-720-10", "68382-720-30", "68382-720-77", "65649-651-02", "65649-651-03", "61269-518-12", "61269-509-06", "0093-6815-55", "0093-6816-55", "49035-703-01", "70771-1075-3", "70771-1075-9", "70771-1075-1", "70771-1075-5", "70771-1075-0", "70771-1075-4", "0536-1112-40", "0536-1112-48", "64980-638-03", "64980-639-03", "69842-001-01", "69097-318-86", "69097-318-87", "69097-318-32", "69097-318-53", "69097-319-86", "69097-319-87", "69097-319-32", "69097-319-53", "69097-321-86", "69097-321-87", "69097-321-32", "69097-321-53", "76282-640-37", "76282-640-38", "76282-641-37", "76282-641-38", "76282-642-37", "76282-642-38", "68012-309-02", "68012-309-30", "68012-309-01", "0115-1687-76", "0115-1687-74", "0115-1689-76", "0115-1689-74", "16714-829-01", "0378-4500-93", "0093-6815-76", "0093-6815-19", "0093-6815-45", "0093-6815-73", "0093-6816-76", "0093-6816-19", "0093-6816-45", "0093-6816-73", "45802-627-01", "45802-627-86", "59651-585-05", "59651-585-30", "65162-778-10", "65162-778-49", "65162-778-18", "65162-778-30", "0487-9701-01", "0487-9701-30", "0487-9601-01", "0487-9601-30", "0574-9855-10", "85612-011-01", "85612-010-01" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "Q3OKS62Q6X" ] } }, { "drugcharacterization": "2", "medicinalproduct": "Cortiment", "drugstructuredosagenumb": "9", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "9 MILLIGRAM, QD", "drugstartdateformat": "610", "drugstartdate": "202411" } ] } } ] }