{ "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": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 68095 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10003305", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2014069067", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014069067" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "48", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug hypersensitivity", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LIPITOR", "drugauthorizationnumb": "020702", "drugdosagetext": "UNK", "drugdosageform": "FILM-COATED TABLET", "actiondrug": "5", "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": [ "e0f7e582-ef7c-4498-9871-55e4f48345ad" ], "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": "1", "medicinalproduct": "LISINOPRIL", "drugdosagetext": "UNK", "actiondrug": "5", "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", "0591-0405", "0591-0406", "0591-0407", "0591-0408", "0591-0885", "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", "02e12641-9edf-4791-8684-5f148f3ed574", "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": "1", "medicinalproduct": "LOSARTAN POTASSIUM", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "ANDA091541", "ANDA217396", "ANDA078243", "ANDA090428", "ANDA203835", "ANDA090083", "NDA020386", "ANDA090382", "ANDA203030", "ANDA215959", "NDA218772", "ANDA090544", "ANDA078232", "ANDA202230", "ANDA091497", "ANDA201170" ], "brand_name": [ "LOSARTAN POTASSIUM", "COZAAR", "LOSARTAN POTASSIUM 25 MG", "LOSARTAN POTASSIUM 50 MG", "LOSARTAN POTASSIUM 100 MG", "ARBLI", "LOSARTAN POTASSIUM TABLETS, 25 MG", "LOSARTAN POTASSIUM TABLETS, 50 MG", "LOSARTAN POTASSIUM TABLETS, 100 MG" ], "generic_name": [ "LOSARTAN POTASSIUM", "LOSARTAN" ], "manufacturer_name": [ "Micro Labs Limited", "Novadoz Pharmaceuticals LLC", "Quallent Pharmaceuticals Health LLC", "Alembic Pharmaceuticals Limited", "Camber Pharmaceuticals, Inc.", "Zydus Lifesciences Limited", "NorthStar RxLLC", "Aurobindo Pharma Limited", "Organon LLC", "Strides Pharma Science Limited", "Unichem Pharmaceuticals (USA), Inc.", "Granules Pharmaceuticals Inc.", "Scienture LLC", "Zydus Pharmaceuticals USA Inc.", "Alembic Pharmaceuticals Inc.", "AiPing Pharmaceutical, Inc.", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals, Inc.", "Macleods Pharmaceuticals Limited", "Granules India Ltd", "Solco Healthcare US, LLC", "Jubilant Cadista Pharmaceuticals Inc." ], "product_ndc": [ "42571-110", "42571-111", "42571-112", "72205-141", "72205-142", "72205-143", "82009-042", "82009-043", "82009-044", "46708-445", "46708-446", "46708-447", "31722-700", "31722-701", "31722-702", "65841-729", "65841-730", "65841-731", "72603-340", "72603-341", "72603-342", "65862-201", "65862-202", "65862-203", "78206-121", "78206-122", "78206-123", "64380-933", "64380-934", "64380-935", "29300-144", "29300-145", "29300-146", "70010-741", "70010-742", "70010-743", "83245-053", "68382-135", "68382-136", "68382-137", "62332-027", "62332-028", "62332-029", "11788-100", "11788-101", "11788-102", "68180-210", "68180-211", "68180-212", "68180-376", "68180-377", "68180-378", "68180-307", "68180-308", "68180-309", "72865-141", "72865-142", "72865-143", "33342-044", "33342-045", "33342-046", "62207-741", "62207-742", "62207-743", "43547-360", "43547-361", "43547-362", "59746-333", "59746-334", "59746-335" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LOSARTAN POTASSIUM" ], "rxcui": [ "979480", "979485", "979492", "979482", "979487", "979494", "2709039", "2709046" ], "spl_id": [ "38dcaa90-daef-cef7-e063-6294a90ab743", "965852b8-5563-4f23-8cd1-a2f82cf16d3f", "55d92567-c635-4877-91cb-dd142c71c4fb", "cedeb352-a540-4778-84e6-304f898fe17f", "40b34aeb-20b5-4200-e063-6394a90a96e9", "36fa833c-716f-4b69-9326-3c54753240dc", "40ccc1d7-14c6-e682-e063-6394a90a1d37", "1942e030-0f36-4f65-9f60-4898439afc61", "998b309b-7dde-4d62-b902-010dd83108fe", "bf3fbbc7-ee52-466f-b5aa-3c6f8cebed32", "cedb47f7-7b7e-464f-b1ed-2a3afdb074d4", "451da3de-077d-522d-e063-6394a90a3537", "0d6183d3-e8e3-416e-a359-9348c61ac736", "0a4867c6-b625-44bf-ad89-79eaf2e490df", "a12a7eb0-196c-4ddc-ba64-2909f65b6f19", "0768a3af-f3b0-406b-bedb-c4c4bf11d1d4", "38431fb6-7157-4be5-929a-0c65b7a29c55", "f26f9307-2adc-692c-e053-2995a90a83a3", "81824d1f-61f4-457c-8723-cd43d5429029", "39e0a359-f9d7-c3fb-e063-6394a90a86a8", "098aef71-90f1-40ee-b574-03dcbbad51a4", "cfcfa1c5-48d3-4370-aa10-e1d054c1844f" ], "spl_set_id": [ "f2f2b6c6-0ab1-483f-b4a2-78dfe3200153", "5edb843a-66ed-4950-9ed0-393e6a5d7c99", "1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f", "eeb77c84-38d3-432d-914a-54b312b374bd", "cafd54e8-42a8-474c-8ea8-49ec74c2b0d3", "9ccd6823-e813-472c-99cd-c6ef25e74bed", "394398e1-119e-4943-b414-27261f5d4842", "31366b4b-dfd6-4fda-babe-2cb3d2c14a2b", "9949448f-c3b9-44ee-94ed-c1aca8c90f39", "a8817f22-8478-49b9-8354-ab27ca222c6b", "92691768-b5e6-4527-98dc-d86c58f6f13e", "ca012edc-923d-4ada-a261-db82b71b3c4f", "afd2d1ba-e7af-4e4e-8b7e-a9f72612fc97", "3233c707-70b6-4c29-8210-913eeb2a38ed", "1dadbe02-289c-4312-9e65-40f3314dcc31", "1ae817aa-5221-4387-a457-306785140741", "e5886220-43b7-46e1-9034-5242ba245bd1", "20421665-0401-4f6e-9e1d-232c654efb0f", "85d69d02-c5ef-467e-94aa-903100218795", "f9953f51-f30a-952d-e053-6394a90abf5f", "fa0cf2c2-6238-4edd-94e2-b670b98a0da4", "1bf520a2-a50e-a6ae-0fdf-9be4e69729c0" ], "package_ndc": [ "42571-110-30", "42571-110-90", "42571-110-10", "42571-111-30", "42571-111-90", "42571-111-10", "42571-112-30", "42571-112-90", "42571-112-10", "72205-141-90", "72205-141-99", "72205-142-30", "72205-142-90", "72205-142-99", "72205-143-30", "72205-143-90", "72205-143-99", "82009-042-10", "82009-043-10", "82009-044-10", "46708-445-30", "46708-445-90", "46708-445-91", "46708-445-31", "46708-446-30", "46708-446-90", "46708-446-91", "46708-446-31", "46708-447-30", "46708-447-90", "46708-447-91", "46708-447-31", "31722-700-30", "31722-700-60", "31722-700-90", "31722-700-05", "31722-700-10", "31722-701-30", "31722-701-60", "31722-701-90", "31722-701-05", "31722-701-10", "31722-702-30", "31722-702-60", "31722-702-90", "31722-702-05", "31722-702-10", "65841-729-16", "65841-729-01", "65841-729-10", "65841-729-24", "65841-729-06", "65841-730-06", "65841-730-16", "65841-730-01", "65841-730-10", "65841-730-24", "65841-731-06", "65841-731-16", "65841-731-01", "65841-731-10", "65841-731-30", "65841-731-77", "72603-340-01", "72603-340-02", "72603-341-01", "72603-341-02", "72603-342-01", "72603-342-02", "65862-201-30", "65862-201-90", "65862-201-05", "65862-201-99", "65862-202-30", "65862-202-90", "65862-202-99", "65862-203-30", "65862-203-90", "65862-203-99", "78206-121-01", "78206-122-01", "78206-122-02", "78206-123-01", "78206-123-02", "64380-933-04", "64380-933-05", "64380-933-08", "64380-934-04", "64380-934-05", "64380-934-08", "64380-935-04", "64380-935-05", "64380-935-08", "29300-144-13", "29300-144-19", "29300-144-01", "29300-144-10", "29300-145-13", "29300-145-19", "29300-145-01", "29300-145-10", "29300-146-13", "29300-146-19", "29300-146-01", "29300-146-10", "70010-741-03", "70010-741-09", "70010-741-10", "70010-742-03", "70010-742-09", "70010-742-10", "70010-743-03", "70010-743-09", "70010-743-10", "83245-053-06", "68382-135-16", "68382-135-01", "68382-135-10", "68382-135-24", "68382-135-06", "68382-136-06", "68382-136-16", "68382-136-01", "68382-136-10", "68382-136-24", "68382-137-06", "68382-137-16", "68382-137-01", "68382-137-10", "68382-137-30", "68382-137-77", "62332-027-30", "62332-027-90", "62332-027-91", "62332-027-31", "62332-028-30", "62332-028-90", "62332-028-91", "62332-028-31", "62332-029-30", "62332-029-90", "62332-029-91", "62332-029-31", "11788-100-30", "11788-100-90", "11788-100-10", "11788-101-30", "11788-101-90", "11788-101-10", "11788-102-30", "11788-102-90", "11788-102-10", "68180-210-09", "68180-210-03", "68180-210-01", "68180-210-06", "68180-211-06", "68180-211-09", "68180-211-03", "68180-211-01", "68180-212-06", "68180-212-03", "68180-212-09", "68180-212-01", "68180-376-03", "68180-376-06", "68180-376-01", "68180-376-09", "68180-377-03", "68180-377-01", "68180-377-09", "68180-377-06", "68180-378-09", "68180-378-03", "68180-378-06", "68180-378-01", "68180-307-01", "68180-307-02", "68180-307-09", "68180-307-06", "68180-308-06", "68180-308-09", "68180-308-02", "68180-308-01", "68180-309-06", "68180-309-09", "68180-309-02", "68180-309-01", "72865-141-30", "72865-141-90", "72865-141-10", "72865-142-30", "72865-142-90", "72865-142-10", "72865-143-30", "72865-143-90", "72865-143-10", "33342-044-10", "33342-044-12", "33342-044-07", "33342-044-44", "33342-045-10", "33342-045-12", "33342-045-07", "33342-045-44", "33342-046-10", "33342-046-12", "33342-046-07", "33342-046-44", "62207-741-54", "62207-741-49", "62207-742-54", "62207-742-49", "62207-743-54", "62207-743-49", "43547-360-09", "43547-360-50", "43547-360-11", "43547-361-03", "43547-361-09", "43547-361-50", "43547-361-11", "43547-362-03", "43547-362-09", "43547-362-50", "43547-362-11", "59746-333-30", "59746-333-90", "59746-333-01", "59746-333-10", "59746-334-30", "59746-334-90", "59746-334-01", "59746-334-10", "59746-335-30", "59746-335-90", "59746-335-01", "59746-335-10" ], "unii": [ "3ST302B24A" ] } }, { "drugcharacterization": "1", "medicinalproduct": "METOPROLOL TARTRATE", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "ANDA204205", "ANDA077761", "ANDA078085", "NDA219373", "ANDA200981", "ANDA077739", "ANDA078950", "ANDA074453", "ANDA091045", "ANDA202871", "NDA218698", "NDA017963", "ANDA076704" ], "brand_name": [ "METOPROLOL TARTRATE", "LOPRESSOR", "METOPROLOL" ], "generic_name": [ "METOPROLOL TARTRATE", "METOROPROLOL TARTRATE", "METOPROLOL" ], "manufacturer_name": [ "Almaject, Inc.", "Hikma Pharmaceuticals USA Inc.", "Hospira, Inc.", "VALIDUS PHARMACEUTICALS LLC", "TRUPHARMA LLC", "Exelan Pharmaceuticals, Inc.", "Aurobindo Pharma Limited", "FOSUN PHARMA USA INC", "Rising Pharma Holdings, Inc.", "Baxter Healthcare Corporation", "Westminster Pharmaceuticals, LLC", "Advagen Pharma Limited", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "TruPharma LLC", "Sagent Pharmaceuticals", "Validus Pharmaceuticals LLC", "Gland Pharma Limited", "Civica, Inc.", "Advagen Pharma Ltd", "Mylan Pharmaceuticals Inc.", "Alembic Pharmaceuticals Limited" ], "product_ndc": [ "72611-740", "0143-9660", "0143-9873", "0409-2016", "30698-464", "52817-250", "52817-251", "52817-252", "52817-253", "52817-254", "76282-794", "76282-795", "76282-796", "59651-758", "59651-760", "72266-122", "57237-100", "57237-101", "57237-102", "36000-033", "69367-354", "69367-355", "72888-004", "72888-101", "72888-005", "72888-023", "72888-006", "63323-660", "62332-112", "62332-113", "62332-114", "65219-665", "30698-460", "52817-358", "52817-362", "52817-359", "52817-361", "52817-360", "0409-1778", "25021-303", "30698-458", "30698-459", "72888-197", "68083-131", "65862-062", "65862-063", "65862-064", "72572-420", "72888-208", "72888-209", "72888-210", "72888-211", "72888-212", "0378-0018", "0378-4593", "0378-0032", "0378-4594", "0378-0047", "46708-290", "46708-291", "46708-292" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "ORAL" ], "substance_name": [ "METOPROLOL TARTRATE" ], "rxcui": [ "866508", "2712147", "2712152", "866511", "866514", "866924", "1606347", "1606349", "2723025", "2723027", "866513", "866516" ], "spl_id": [ "ede4ae40-88e0-0536-3e01-2f2ac0b5ae3c", "6a34f3f1-4b17-4864-97ec-405fffb45f20", "99c56211-4024-48e5-b46d-840a88f4b16d", "352cee93-db0d-1c05-e063-6294a90a7533", "2261de1d-98d7-8d12-e063-6394a90a33b1", "562ee54a-9c4d-4677-9b0b-bc3bdd2809bd", "2d3b41ae-f657-4459-bdee-e76e644ec167", "4303a757-2cec-f9c6-e063-6294a90a0fc6", "a688acb3-72c6-4fcf-b225-648ae694279f", "5d975af3-d078-4130-9448-ed77123f1aac", "451f6d3f-6a31-fb28-e063-6294a90a06a0", "48450d44-3cc6-45be-e063-6394a90aac70", "4066607a-15cb-42ac-999e-5254907dda5a", "c7738f42-299e-4bea-af50-778e069352f0", "ccb1a15e-c943-4042-ae46-550bdabfc96b", "494efa43-aa90-d6f4-e063-6294a90a11ac", "294dc99d-4a6d-22b6-e063-6394a90a06aa", "3f4f1186-294b-4192-b024-83f7615f8bf3", "b0c162ae-0af5-4443-9136-edf762c90e11", "28c4fc69-5609-49ec-8fe5-4d7bc8f88288", "4984fefe-6924-2aa6-e063-6394a90a1853", "32f3e39e-0df1-4cd0-96f1-14d69d7b827d", "d265c99d-8e77-4a78-b542-15e957d9d335", "08b65561-0817-44e6-a23b-b68ab6ee2666", "3e9a73a5-7f4a-1caa-e063-6394a90a89bc", "57d60035-d408-4f98-932e-2cbbeae5326c", "f31d2aef-f902-4984-803c-5bdb015e9253" ], "spl_set_id": [ "f0370951-ab26-d4d1-b857-57518f3c4175", "c7ec36bb-bc6f-42de-9974-a50ac13e9410", "f65e93ec-4db6-44fa-bff1-8ae89aa8243f", "9f448171-9588-4a54-88b3-5d870060ce86", "92ab5942-823d-43aa-8e7a-56844ab8946f", "f54b250d-bd15-483b-b191-a664291382c1", "ac4ac150-d3e6-4bd1-8a4a-7d63fade3e49", "1e787808-b3e0-417a-b333-80619d15432b", "30b2b576-4939-4903-be59-dbd1624a5eb6", "09566368-f91d-43a3-b683-30c844fb125a", "4d352c34-47f8-4662-9ac5-d5a32bd1660f", "a401fe31-d51a-49d9-a062-c9d22088db56", "be1c686e-37a5-4a53-945b-68a6ead35134", "24837d82-0f3f-4482-9af0-31e5f675c30f", "ccb1a15e-c943-4042-ae46-550bdabfc96b", "b5f4fed2-369c-4808-a682-8a5b8cfdbb4f", "52c822f2-4a71-4ab2-a470-58074622846a", "7c1f998a-233d-4feb-6ea2-457702abd0d2", "f3817543-544a-4afa-ac7c-c1b48c1307c2", "0283bc9d-6998-493a-824a-d4c85f704111", "d62a972a-bc45-4582-9701-bed27a1a9e4d", "e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe", "2b705cb6-cb75-4c2a-907a-4bd45d18bc2c", "8dae76a2-32e7-40a2-bb70-9c6380b9b330", "3ecff825-34ea-4535-b935-627bf2c13d93", "809c6386-0039-42ff-a03e-e42733e229b8", "cb76a73f-549a-4170-b96a-f93ed7e09464" ], "package_ndc": [ "72611-740-01", "72611-740-10", "0143-9873-10", "0143-9873-25", "0143-9660-01", "0143-9660-10", "0409-2016-05", "0409-2016-10", "30698-464-30", "30698-464-31", "52817-250-10", "52817-250-00", "52817-251-10", "52817-252-10", "52817-252-00", "52817-253-10", "52817-254-10", "52817-254-00", "76282-794-01", "76282-794-10", "76282-795-01", "76282-795-10", "76282-796-01", "76282-796-10", "59651-758-01", "59651-760-01", "72266-122-01", "72266-122-10", "72266-122-25", "57237-100-01", "57237-100-99", "57237-101-01", "57237-101-99", "57237-102-01", "57237-102-99", "36000-033-10", "69367-354-01", "69367-354-10", "69367-355-01", "69367-355-10", "72888-004-01", "72888-004-05", "72888-004-00", "72888-101-01", "72888-101-05", "72888-005-01", "72888-005-05", "72888-005-00", "72888-023-01", "72888-023-05", "72888-006-01", "72888-006-05", "72888-006-00", "63323-660-01", "63323-660-05", "62332-112-30", "62332-112-31", "62332-112-91", "62332-113-30", "62332-113-31", "62332-113-91", "62332-114-30", "62332-114-31", "62332-114-91", "65219-665-01", "65219-665-05", "30698-460-03", "30698-460-01", "30698-460-10", "52817-362-10", "52817-362-00", "52817-359-10", "52817-359-50", "52817-361-10", "52817-361-00", "52817-360-10", "52817-360-00", "52817-358-10", "52817-358-50", "0409-1778-15", "0409-1778-05", "25021-303-05", "30698-458-01", "30698-459-01", "72888-197-30", "72888-197-03", "72888-197-00", "68083-131-01", "65862-062-01", "65862-062-99", "65862-063-60", "65862-063-01", "65862-063-99", "65862-064-60", "65862-064-01", "65862-064-99", "72572-420-01", "72572-420-10", "72888-208-01", "72888-208-05", "72888-208-00", "72888-208-02", "72888-209-01", "72888-209-05", "72888-210-01", "72888-210-05", "72888-210-00", "72888-210-02", "72888-211-01", "72888-211-05", "72888-212-01", "72888-212-05", "72888-212-00", "0378-0018-01", "0378-0018-05", "0378-4593-01", "0378-0032-01", "0378-0032-10", "0378-4594-01", "0378-0047-01", "0378-0047-10", "46708-290-30", "46708-290-31", "46708-290-91", "46708-290-10", "46708-290-71", "46708-291-30", "46708-291-31", "46708-291-91", "46708-291-10", "46708-292-30", "46708-292-31", "46708-292-91", "46708-292-10" ], "unii": [ "W5S57Y3A5L" ] } }, { "drugcharacterization": "1", "medicinalproduct": "MINOCYCLINE", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "NDA212379", "NDA213690" ], "brand_name": [ "AMZEEQ", "ZILXI" ], "generic_name": [ "MINOCYCLINE" ], "manufacturer_name": [ "Journey Medical Corporation" ], "product_ndc": [ "69489-201", "69489-212" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "MINOCYCLINE HYDROCHLORIDE" ], "rxcui": [ "2257673", "2257678", "2375333", "2375338" ], "spl_id": [ "28ee8ff9-b982-4e9d-e063-6294a90a900c", "e5d4b4fa-1951-4fa8-9677-acb97b10c087" ], "spl_set_id": [ "cc251492-977b-4eb1-a088-a90831324bad", "cbffa96e-2446-43cf-ba5e-38c645302afd" ], "package_ndc": [ "69489-201-30", "69489-201-03", "69489-212-30", "69489-212-07", "69489-212-03" ], "unii": [ "0020414E5U" ] } }, { "drugcharacterization": "1", "medicinalproduct": "BACTRIM", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "NDA017377" ], "brand_name": [ "BACTRIM" ], "generic_name": [ "SULFAMETHOXAZOLE AND TRIMETHOPRIM" ], "manufacturer_name": [ "Sun Pharmaceutical Industries, Inc" ], "product_ndc": [ "49708-145", "49708-146" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SULFAMETHOXAZOLE", "TRIMETHOPRIM" ], "rxcui": [ "198334", "198335", "208416", "849580" ], "spl_id": [ "2a76a544-1f84-4b42-e063-6394a90a08d5" ], "spl_set_id": [ "f59d0c04-9c66-4d53-a0e1-cb55570deb62" ], "package_ndc": [ "49708-146-01", "49708-145-01" ], "nui": [ "N0000175489", "N0000000191", "N0000187062", "N0000187061", "N0000175504", "M0020790", "N0000185504" ], "pharm_class_epc": [ "Dihydrofolate Reductase Inhibitor Antibacterial [EPC]", "Sulfonamide Antimicrobial [EPC]" ], "pharm_class_moa": [ "Dihydrofolate Reductase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]" ], "pharm_class_cs": [ "Sulfonamides [CS]" ], "unii": [ "AN164J8Y0X", "JE42381TNV" ] } } ] } } ] }