{ "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": 18509 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10016812", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140318", "receiptdateformat": "102", "receiptdate": "20140318", "fulfillexpeditecriteria": "1", "companynumb": "PHHY2014US029457", "duplicate": "1", "reportduplicate": { "duplicatesource": "SANDOZ", "duplicatenumb": "PHHY2014US029457" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "31", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Death", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Mixed hepatocellular cholangiocarcinoma", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Malignant neoplasm progression", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Infusion related reaction", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Tachycardia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vomiting", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CISPLATIN", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "009", "drugdosagetext": "25 MG/M2, ON DAY 1 AND DAY 8 OF A 21-DAY CYCLE", "drugindication": "MIXED HEPATOCELLULAR CHOLANGIOCARCINOMA", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA074656", "NDA018057", "ANDA075036", "ANDA207323", "ANDA206774", "ANDA218868", "ANDA074735" ], "brand_name": [ "CISPLATIN" ], "generic_name": [ "CISPLATIN" ], "manufacturer_name": [ "Teva Parenteral Medicines, Inc.", "WG Critical Care, LLC", "Hikma Pharmaceuticals USA Inc.", "Sagent Pharmaceuticals", "BluePoint Laboratories", "Accord Healthcare Inc.", "Apotex Corp.", "FOSUN PHARMA USA INC", "Fresenius Kabi USA, LLC", "Gland Pharma Limited" ], "product_ndc": [ "0703-5747", "0703-5748", "44567-530", "0143-9504", "0143-9505", "25021-253", "44567-509", "44567-510", "44567-511", "68001-283", "16729-288", "60505-6279", "72266-252", "72266-253", "63323-103", "68083-162", "68083-163", "68001-608", "68001-609", "65219-359" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "CISPLATIN" ], "rxcui": [ "309311", "1736854" ], "spl_id": [ "adf5773e-9095-4cb4-a90f-72cbf82f4493", "a66eda32-1164-439a-ac8e-73138365ec06", "b463892e-6ca3-4c57-ae72-bdd3a7370a08", "bf489cd3-17a3-4398-ba7e-2cb9e87b9c13", "dd45d777-d4c1-40ee-b4f0-c9e001a15a8c", "11314cd7-5167-4699-e063-6394a90a93b8", "2860827e-1817-2b85-e063-6394a90a127e", "0e147fbc-5660-4d80-b834-f069e8487f59", "189a1ee6-231d-7e56-e063-6394a90abc01", "24604fc6-875c-4f70-973a-9cca93f9a7a7", "89007399-3c34-40d2-8068-a0b8e09cbef8", "0c3ef530-de61-73f7-e063-6294a90a9973", "a91e4890-e792-422b-92f3-8eb99c31aeb7" ], "spl_set_id": [ "a440f077-46f6-4688-a209-65bce38d1c92", "508496cb-3441-46b3-a4fe-e0d440e6adc6", "76aea034-6d58-4390-a164-36aa09c1f101", "00396546-6a80-4b9f-a5f8-c22c1d1bb173", "2bf8d2fb-80c8-401d-8e9b-d58463f5e954", "a60c5173-6bc0-4c9d-9674-b3f4d68f79ba", "b2b029f5-0d7e-4e7f-accc-b722aec34c68", "8d170f6f-37d7-41ce-aae2-33307a6ef3ae", "0219eae9-82b4-b779-e063-6394a90a311e", "de6302d5-85f0-4116-a709-57826c2c84fe", "a32820f7-9ff6-4c13-a96a-4483a943fe82", "0372598e-4837-43c6-b56f-63527ac94559", "851e111b-d7c9-4781-849b-3d036e13ce3f" ], "package_ndc": [ "0703-5747-11", "0703-5748-11", "44567-530-01", "0143-9505-01", "0143-9504-01", "25021-253-50", "25021-253-51", "44567-509-01", "44567-510-01", "44567-511-01", "68001-283-24", "68001-283-27", "68001-283-33", "68001-283-32", "16729-288-11", "16729-288-38", "60505-6279-0", "72266-252-01", "72266-253-01", "63323-103-51", "63323-103-65", "63323-103-64", "68083-162-01", "68083-163-01", "68001-608-24", "68001-609-33", "65219-359-50" ], "nui": [ "N0000175413", "N0000175073" ], "pharm_class_epc": [ "Platinum-based Drug [EPC]" ], "unii": [ "Q20Q21Q62J" ] } }, { "drugcharacterization": "1", "medicinalproduct": "GEMCITABINE", "drugstructuredosagenumb": "1000", "drugstructuredosageunit": "009", "drugdosagetext": "1000 MG/M2, ON DAY 1 AND DAY 8 OF A 21-DAY CYCLE", "drugindication": "MIXED HEPATOCELLULAR CHOLANGIOCARCINOMA", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA212129", "ANDA210991", "ANDA213175", "NDA200795", "ANDA079183", "ANDA090799", "ANDA202485", "ANDA091365", "ANDA078339", "ANDA209077", "ANDA205242", "NDA219920", "NDA209604" ], "brand_name": [ "GEMCITABINE", "AVGEMSI" ], "generic_name": [ "GEMCITABINE HYDROCHLORIDE", "GEMCITABINE" ], "manufacturer_name": [ "Meitheal Pharmaceuticals Inc.", "Armas Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Hospira, Inc.", "Fresenius Kabi USA, LLC", "Sagent Pharmaceuticals", "Dr. Reddy's Laboratories Limited", "NorthStar Rx LLC", "Mylan Institutional LLC", "Avyxa Pharma, LLC", "BluePoint Laboratories" ], "product_ndc": [ "71288-117", "72485-223", "0143-9340", "0143-9341", "0143-9342", "0409-0181", "0409-0183", "0409-0182", "0409-0187", "63323-102", "63323-125", "25021-234", "25021-235", "71288-113", "71288-114", "72485-221", "55111-686", "55111-687", "63323-126", "0409-0185", "0409-0186", "25021-239", "16714-909", "16714-930", "67457-616", "67457-617", "67457-618", "72485-222", "83831-123", "83831-122", "83831-124", "68001-342", "68001-348", "68001-350", "68001-359" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "GEMCITABINE HYDROCHLORIDE" ], "rxcui": [ "1720960", "1720975", "1720977", "1719005", "1719000", "1719003", "2719761", "2719763", "1998783" ], "spl_id": [ "c5bbcd6c-28a2-4db0-86dd-4c9ce60a434f", "470dbc2b-c18a-403d-b815-3c6e296a7f41", "e9bd951d-0a47-409c-aa7c-2df9157d94e2", "3a284abb-8c57-47dc-a138-5a6e6ab92b05", "9788e02c-b92a-4ec3-a747-1574a3a76918", "4c447f74-d06c-459b-ba63-6b72aaf4fd2e", "595a8cf5-412a-482d-8d77-979741ee4912", "be3f7738-022f-4b20-94f3-40f5337997c1", "b696b925-51e8-48a8-881e-ae0a0373b3c2", "52a15e83-e33d-42e7-9270-636b5b59d63b", "12d7e1d6-334a-7d1c-2db2-ea73c496d9ff", "ce96743d-23fc-4de4-9df1-b650d64f4cbc", "111b13bb-6793-4b33-b845-0dc9b46837de", "9c9d382b-8f9a-4fbe-a231-44d73ec83b61", "adf9b715-8cef-4a0d-ba30-d948b2b04272", "3907fd14-53af-499a-8334-94adb74142e0", "93d514c4-a877-475d-91e0-9cfb232d55ca", "3f1b1931-04c8-45ba-afbb-4daf5e05a69f", "303c41a6-c142-4cd2-b133-9e610845d5bf", "049982fe-a321-b868-e063-6294a90ae861" ], "spl_set_id": [ "73ae04d8-38f9-4d3d-b0c2-71d22af1fc86", "518b9c2e-fdbe-46de-9859-02314c220d58", "d80176fe-3e8b-48be-87c2-9c603013b3fa", "dc02a23b-3ff9-4441-aa91-8e9e629a7315", "a625c92b-c569-4b98-8d2e-2b3f5e12b34f", "d1f3951c-d13f-4662-ad4b-ecfc07f59104", "44bcc16c-341d-49e8-a1c6-95d084667aca", "c0b1b715-9ff8-43ca-9e49-465f1f380084", "a5949d02-29eb-4626-ad35-b7614bb0fa95", "57b80f66-208d-4903-9443-e4c9239e3207", "eafcebc8-ddef-bb6b-fd0a-9d8b9962cdc4", "c550dd16-a5e8-44be-87f2-210c15bbb513", "d16907e7-a8c8-4039-ace4-cf4e24ba68c0", "e18ed1cb-7dd0-4001-bfda-17d1f4587fb8", "22af3507-4b4f-4cad-9d61-89ffc4aabbc7", "5af49a48-f1c0-467d-b5da-ac9f1ae8e34c", "06dd9d40-74fc-4409-93b1-a46be7126331", "5b6be4b4-1f0a-4da2-b5d2-2592f401f90b", "e11eeff7-bcaf-4bf1-8da8-88138e01af84", "4031017d-d768-46de-8081-476bcb883f5e" ], "package_ndc": [ "71288-117-06", "71288-117-28", "71288-117-54", "72485-223-20", "0143-9340-01", "0143-9341-01", "0143-9342-01", "0409-0181-01", "0409-0183-01", "0409-0182-01", "0409-0187-01", "63323-102-94", "63323-125-94", "25021-234-10", "25021-235-50", "25021-235-51", "71288-117-91", "71288-117-92", "71288-117-93", "71288-113-10", "71288-114-50", "72485-221-02", "55111-686-07", "55111-687-25", "63323-102-13", "63323-125-53", "63323-126-03", "0409-0185-01", "0409-0186-01", "0409-0181-25", "0409-0182-25", "0409-0183-25", "25021-239-05", "25021-239-26", "25021-239-52", "16714-909-01", "16714-930-01", "67457-616-10", "67457-617-30", "67457-618-10", "72485-222-10", "83831-122-01", "83831-123-01", "83831-124-01", "68001-342-34", "68001-348-36", "68001-350-68", "68001-359-37" ], "unii": [ "U347PV74IL" ] } }, { "drugcharacterization": "1", "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": "75327", "drugindication": "MIXED HEPATOCELLULAR CHOLANGIOCARCINOMA", "actiondrug": "1", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA089717", "ANDA040056", "ANDA040335", "ANDA203800", "ANDA074544", "ANDA071198", "ANDA071199", "ANDA200753", "ANDA200855", "ANDA213929", "ANDA089384", "ANDA207241", "NDA220406", "ANDA216590", "ANDA040258", "ANDA218200", "ANDA072733", "ANDA072734", "ANDA072735", "ANDA072736", "ANDA209110", "ANDA040286", "ANDA207226", "ANDA217021", "ANDA211132" ], "brand_name": [ "LEUCOVORIN CALCIUM", "VYKOURA" ], "generic_name": [ "LEUCOVORIN CALCIUM" ], "manufacturer_name": [ "BluePoint Laboratories", "Mylan Institutional LLC", "Epic Pharma LLC", "Teva Pharmaceuticals USA, Inc.", "Sagent Pharmaceuticals", "Leading Pharma, LLC", "Hikma Pharmaceuticals USA Inc.", "Fresenius Kabi USA, LLC", "Avyxa Pharma, LLC", "Meitheal Pharmaceuticals Inc.", "Gland Pharma Limited", "GLENMARK PHARMACEUTICALS INC., USA", "Slate Run Pharmaceuticals, LLC", "Ingenus Pharmaceuticals, LLC" ], "product_ndc": [ "68001-416", "68001-417", "68001-418", "67457-528", "67457-529", "67457-530", "42806-133", "42806-358", "42806-134", "42806-359", "0555-0484", "0555-0485", "25021-813", "25021-814", "25021-815", "25021-816", "69315-184", "69315-185", "69315-186", "69315-187", "0143-9552", "0143-9555", "0143-9554", "0143-9553", "63323-631", "83831-147", "83831-148", "83831-149", "68001-648", "68001-649", "68001-650", "63323-710", "71288-160", "71288-161", "71288-162", "71288-163", "71288-164", "68083-587", "0143-9368", "0054-4496", "0054-4497", "0054-4498", "0054-4499", "0054-8496", "68462-767", "25021-828", "63323-711", "70436-116", "70436-117", "70436-118", "70436-120", "70436-119", "50742-181", "50742-182", "50742-183", "50742-184" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS", "ORAL" ], "substance_name": [ "LEUCOVORIN CALCIUM" ], "rxcui": [ "237788", "1803932", "1803937", "197860", "197861", "197862", "197863", "1803930", "2099993", "2104714", "2735355", "2735359", "2735364", "2735365", "2735366", "2055036" ], "spl_id": [ "d5ee26ca-d963-687f-e053-2a95a90a2a50", "2890b03c-dbef-4db8-8b07-c042d7765677", "9db189e6-7ecc-465c-8197-c454350a45dc", "3ba61b64-dd4e-44d7-8348-85a193c7c267", "ff2ba160-e2f9-4ab9-9e67-2409f02c923e", "f6c54ab5-7d54-4530-955d-206903b9dcad", "e2d1484b-2920-45ab-9207-4caa5285fef4", "d1c72e5d-c25e-4b9c-b3dc-a8d0b746db3f", "c655613e-4381-461e-8e2d-4121be761c04", "3ff11eb8-de81-1e0d-e063-6394a90a0f7c", "b70ccebd-b847-41ff-8c30-9779461465e0", "077a459b-e884-4452-aed3-0857a38ce26f", "0ac32e99-c204-4104-8d83-4a24c0baccf1", "0000f768-a8cc-46ba-95a1-88b0ebd09be7", "3ea4147c-f529-42ad-8672-4d36ab4c2b37", "79d023ab-7d77-48c1-8f47-ea322fd58c2b", "4619074b-a86b-41a6-bd98-76d15166764c", "2497bd71-0f85-48ec-9353-d591e1c728f8", "a0d41f71-6197-4c9a-8cd2-217945cb722b", "2a4aaed3-885e-bc10-e063-6294a90a61af", "93e939b7-2201-442a-a2be-7c5804f8be6f" ], "spl_set_id": [ "e9b47126-8b52-43ff-85c4-33d32b3d8326", "1cb701ca-2478-4268-9d69-80293965d59d", "2627a485-05b5-4dab-ac20-dc840e5c469d", "94669fc8-3c1c-4228-be27-09a1cd468c36", "9d0e5356-ff39-4a8e-944c-e808a21ef4b2", "c8102043-79f2-421a-b849-94bac19007a6", "cc52077f-5663-4f79-a273-0aecf655e038", "d5d4f0fd-7520-43a9-9acc-f7e117e1f6ee", "d122b875-435e-4e00-b945-7a0546df95c2", "f579879c-7d53-4663-8ad8-84b8b645cda5", "ab691d4e-e0d1-4ba1-9c7a-1cdcfcc3c17c", "9df20901-6980-4d4e-89ec-40f3c1f91852", "968b192b-72f3-41b0-a1f5-bab8a96d3419", "f198ab39-9394-4280-be44-93a88264a450", "33663425-4731-4977-9127-9e59b6b91497", "79d023ab-7d77-48c1-8f47-ea322fd58c2b", "c0cbcbf6-6fd2-4cf3-877a-bb0fe3df4e59", "e3b957dc-a542-4f69-b8a0-7df401ee706f", "4b72d1fd-f389-45d9-b43b-510b45c92263", "d8bdd60c-9a1c-4ef4-ba6b-b911849128f1", "7409cdee-9093-47af-a4c4-2c55ce1b6361" ], "package_ndc": [ "68001-416-36", "68001-417-37", "68001-418-38", "67457-528-10", "67457-529-20", "67457-530-35", "42806-358-30", "42806-358-01", "42806-133-21", "42806-133-24", "42806-134-24", "42806-359-25", "0555-0484-01", "0555-0484-02", "0555-0485-27", "25021-813-10", "25021-814-30", "25021-815-30", "25021-816-30", "69315-184-03", "69315-184-01", "69315-185-12", "69315-185-24", "69315-186-24", "69315-187-25", "0143-9555-01", "0143-9554-01", "0143-9553-01", "0143-9552-01", "63323-631-10", "83831-147-05", "83831-148-35", "83831-149-50", "68001-648-36", "68001-649-37", "68001-650-38", "63323-710-59", "71288-160-10", "71288-161-20", "71288-162-30", "71288-163-30", "71288-164-50", "68083-587-01", "0143-9368-01", "0054-4496-25", "0054-4496-13", "0054-4497-10", "0054-4497-05", "0054-4498-10", "0054-4499-11", "0054-8496-19", "68462-767-35", "25021-828-50", "63323-710-50", "63323-711-00", "63323-631-50", "70436-116-80", "70436-116-82", "70436-117-80", "70436-118-80", "70436-120-80", "70436-119-80", "50742-181-30", "50742-181-01", "50742-182-12", "50742-182-24", "50742-183-24", "50742-184-25" ], "unii": [ "RPR1R4C0P4" ] } }, { "drugcharacterization": "1", "medicinalproduct": "FLUOROURACIL", "drugindication": "MIXED HEPATOCELLULAR CHOLANGIOCARCINOMA", "actiondrug": "1", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA020985", "ANDA202668", "ANDA217676", "ANDA040278", "ANDA210124", "ANDA217295", "NDA016831", "ANDA210123", "ANDA215612", "ANDA076526", "ANDA203609", "ANDA040743", "ANDA040798", "NDA022259", "ANDA090368", "ANDA077524", "ANDA214845", "NDA220201", "ANDA216494", "ANDA040279", "ANDA216942", "ANDA215699", "ANDA202669" ], "brand_name": [ "FLUOROURACIL", "TOLAK", "EFUDEX", "FAVLYXA" ], "generic_name": [ "FLUOROURACIL CREAM, 0.5%", "FLUOROURACIL" ], "manufacturer_name": [ "Dr. Reddy's Laboratories Inc.", "Eugia US LLC", "Alembic Pharmaceuticals Inc.", "Fresenius Kabi USA, LLC", "BluePoint Laboratories", "Mylan Pharmaceuticals Inc.", "Gland Pharma Limited", "Encube Ethicals, Inc.", "Taro Pharmaceuticals U.S.A., Inc.", "Sagent Pharmaceuticals", "Accord Healthcare, Inc.", "Xiromed LLC", "Alembic Pharmaceuticals Limited", "HILL DERMACEUTICALS, INC.", "Dr. Reddy's Labratories Inc.", "Accord Healthcare Inc.", "Bausch Health US, LLC", "Avyxa Pharma, LLC", "Mayne Pharma Inc.", "Meitheal Pharmaceuticals Inc.", "NORTHSTAR RX LLC" ], "product_ndc": [ "75907-169", "55150-496", "55150-497", "62332-779", "63323-117", "68001-525", "62332-751", "0378-4791", "68083-269", "68083-270", "21922-041", "51672-4062", "51672-4063", "25021-215", "16729-276", "70700-188", "70700-189", "70700-186", "70700-187", "46708-779", "28105-421", "51672-4118", "68001-524", "75907-095", "68001-628", "16729-542", "0187-3204", "0187-3202", "0187-3203", "83831-143", "51862-362", "46708-751", "68001-627", "71288-170", "21922-049", "71288-154", "55150-498", "55150-499", "68083-292", "68083-293", "16714-178" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "FLUOROURACIL" ], "rxcui": [ "284191", "1791701", "1791736", "239177", "310380", "310379", "1669868", "1669873", "105583", "213045", "2738666", "2738672" ], "spl_id": [ "39a2cbc0-f588-5397-e063-6394a90a5390", "7784c6bc-2624-42ba-a4ea-c63624eecec9", "15b365c5-47e3-4788-8df8-b0f6f323cd44", "7667002e-a888-47f5-8eec-519bfb2ebfb2", "e1f73bef-26d8-419c-96c1-a8f8aa201c63", "4bbe6cbf-4510-e811-e063-6294a90a0e28", "877caa50-ffd0-4c33-b61d-676c0b6ec82a", "1ff72539-1af5-41bf-8720-1ba12df35abc", "0e5faa31-6fd8-49b5-b838-1278cf068666", "f42c30f3-a83e-4721-8aa1-50d56cb13f4e", "3225bf24-833e-4d6a-bfe8-08df4fecb218", "223c5d8d-c064-4a0a-8490-b1c4aa0e706d", "4a675041-f691-5dcf-e063-6394a90a87c4", "4b35e0c2-3335-94bf-e063-6394a90a9454", "4b35b4f1-4de4-42de-e063-6294a90a10ae", "4a6723ea-dd4c-3f28-e063-6394a90a7378", "b6b0d9e2-c6f0-4523-a33b-b958d32d3a28", "db3a1489-fcb1-4442-b309-4eb8ad9b9f46", "170232f3-4992-1e1a-e063-6394a90a38e9", "4bbe764b-4bfd-3862-e063-6394a90a7cc0", "8ad197d1-c61c-41a1-bba4-ce5b7d1e8696", "984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3", "4e593090-faf2-cd72-e063-6294a90a2957", "23a8557b-45e6-e3cf-e063-6394a90a4b0d", "3375c5f7-9b6f-8ca1-e063-6394a90aaff8", "c8c3a5e0-277e-4d3e-910c-62cbc241cc3a", "d05a8a27-b7f9-40cc-a36a-97209fc998b1", "d10f12a2-7b38-4351-93df-1e8444d2a9e4", "4e58f3fc-4167-e42c-e063-6294a90a9fcb", "cb5958dc-12bd-4172-b45e-34b591eb316c", "0c579d19-82e7-4aac-bcb6-b3a60a3b48a3", "f33d88a4-f57f-45c7-8c13-94d69e4d7931", "d8218f3a-10d0-49d8-aa74-bae082019db2", "0097ac5b-1a37-46b0-8e5b-d8ae2311a25d", "692008d1-c9e5-40d2-a935-cd49e0cb95e5", "4680580c-772c-490d-bde9-c506c961e0b8", "d67aa3a4-76dd-496e-824f-c1a3ba0117a9", "7106b404-bb4d-43e4-9809-17bd2e95a63b" ], "spl_set_id": [ "37dcfb83-0e7d-d23d-9cd5-afa5bdc30628", "199ef964-8a9b-403e-a2ae-759280b3d1d1", "fdee9255-9447-4ae7-951d-b694802b5966", "21af1777-87f7-4e40-9917-f1677e7ff1a5", "beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff", "300304fa-4791-4455-962c-493ae467f504", "6b34cbf2-66f9-48a4-b41f-deb84ba8e8c4", "744737c5-0d96-4214-82ab-6cff016b1ea0", "572b710e-8e2b-46eb-bd80-648ad769d34d", "2c631ce7-ea15-4b51-b5bc-4962e3c315cd", "1b2f6145-b338-42ed-88a7-f4da65c59164", "37e35e8c-5d51-413b-a3a0-b72a18caaf65", "66d451fe-2436-494c-80c5-4528c8e34369", "f4b0cae1-a2fc-2991-d663-3b729503cd1c", "19735014-c6fb-0a05-c330-2e9389c71216", "8eff167f-203a-4a81-b2fc-d8773bc3555e", "b6b0d9e2-c6f0-4523-a33b-b958d32d3a28", "59de2709-00b8-4f0a-867c-f0dfeb947192", "acca0036-f19c-459b-9dfc-9592f1cd588d", "9c42eeff-ab0c-4820-94d7-e1a3df9fda74", "b4328ae3-f48f-40b1-9719-1c1aced7c734", "e137c766-1f7f-0251-90b9-450c3d4d78b9", "c612b05f-f37d-47fa-9c1e-b2d876dd7093", "667d4059-de90-4d3f-86c2-c2573def2ecb", "35de1c1c-bef5-46c5-b6f8-ea032147411c", "1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b", "06475bd8-66d9-4f88-90e4-b367480dab39", "d10f12a2-7b38-4351-93df-1e8444d2a9e4", "cdf07a8b-91ee-424f-8c04-34f53dfb82be", "a0cd6301-c6e0-4b62-8683-39c99913db24", "c45f5286-a52b-43e5-8a6f-d0312e7da0c8", "30294dd2-40fb-420d-b838-376343308895", "a85ab26a-05ea-498f-8f34-564a925fa9d9", "de8a3fce-85a9-4a77-a3cd-e50179b93098", "697816ce-dc05-4943-b7f0-2f0b125e93b7", "ea3497db-23b9-4ace-9a6f-b54853d04a82", "fdf2a165-2ca4-48be-89c1-570e6010b47c", "52ef5f41-2312-4b55-aa86-abd5bb28b9d3" ], "package_ndc": [ "75907-169-11", "55150-496-01", "55150-496-10", "55150-497-01", "55150-497-10", "62332-779-31", "63323-117-58", "63323-117-68", "63323-117-51", "63323-117-61", "68001-525-27", "68001-525-32", "62332-751-50", "0378-4791-06", "68083-269-01", "68083-269-10", "68083-270-01", "68083-270-10", "21922-041-12", "51672-4062-1", "51672-4063-1", "25021-215-98", "25021-215-99", "16729-276-03", "16729-276-68", "16729-276-05", "16729-276-67", "70700-188-22", "70700-189-22", "70700-187-22", "70700-187-23", "70700-186-22", "70700-186-23", "16729-276-11", "16729-276-38", "46708-779-31", "28105-421-40", "51672-4118-5", "51672-4118-2", "51672-4118-6", "68001-524-28", "68001-524-30", "68001-524-29", "68001-524-31", "63323-117-59", "63323-117-69", "75907-095-40", "68001-628-32", "16729-542-35", "0187-3202-10", "0187-3202-02", "0187-3203-10", "0187-3203-02", "0187-3204-47", "83831-143-01", "51862-362-40", "46708-751-50", "68001-627-27", "71288-170-75", "63323-117-00", "63323-117-10", "63323-117-01", "63323-117-20", "21922-049-17", "63323-117-43", "63323-117-18", "63323-117-41", "63323-117-28", "71288-154-76", "55150-498-01", "55150-499-01", "68083-292-01", "68083-293-01", "63323-117-31", "63323-117-19", "16714-178-01" ], "nui": [ "N0000000233", "N0000175595" ], "pharm_class_moa": [ "Nucleic Acid Synthesis Inhibitors [MoA]" ], "pharm_class_epc": [ "Nucleoside Metabolic Inhibitor [EPC]" ], "unii": [ "U3P01618RT" ] } }, { "drugcharacterization": "1", "medicinalproduct": "OXALIPLATIN", "drugindication": "MIXED HEPATOCELLULAR CHOLANGIOCARCINOMA", "actiondrug": "1", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA207325", "ANDA217925", "ANDA203869", "ANDA207474", "ANDA204616", "ANDA217348", "ANDA204368", "ANDA078817", "ANDA078813", "ANDA219765", "ANDA091358", "NDA021759", "ANDA078811", "ANDA205529", "ANDA207385" ], "brand_name": [ "OXALIPLATIN" ], "generic_name": [ "OXALIPLATIN" ], "manufacturer_name": [ "Meitheal Pharmaceuticals Inc.", "FOSUN PHARMA USA INC.", "Gland Pharma Limited", "Camber Pharmaceuticals, Inc.", "Sagent Pharmaceuticals", "Accord Healthcare Inc.", "Qilu Pharmaceutical Co., Ltd.", "Sandoz Inc", "Hospira, Inc.", "Apotex Corp.", "Shandong New Time Pharmaceutical Co., Ltd.", "Mylan Institutional LLC", "BluePoint Laboratories", "Winthrop U.S, a business of sanofi-aventis U.S. LLC", "Fresenius Kabi USA, LLC", "Baxter Healthcare Corporation", "Northstar Rx LLC", "Eugia US LLC", "NorthStar Rx LLC" ], "product_ndc": [ "71288-149", "72266-161", "72266-162", "68083-176", "68083-177", "68083-314", "31722-357", "31722-358", "71288-101", "25021-233", "16729-332", "67184-0501", "67184-0502", "71288-171", "71288-172", "67184-0508", "67184-0509", "67184-0510", "0781-3315", "0781-3317", "61703-363", "60505-6132", "42677-336", "42677-337", "67457-442", "67457-469", "68001-468", "60505-6287", "0955-1731", "0955-1733", "63323-750", "43066-014", "43066-018", "72603-320", "72603-420", "55150-331", "55150-332", "72603-101", "72603-301", "68083-170", "68083-171", "0781-9315", "0781-9317" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "OXALIPLATIN" ], "rxcui": [ "1736776", "1736781", "1797528", "1736784", "1736786" ], "spl_id": [ "fb8d544c-a5df-4648-9422-9d53141d3a70", "2b48f7c2-8c48-6b82-e063-6394a90a3baf", "4ccc9b7c-9bf8-4e27-8c38-f98e80360fcf", "3fee20f4-5fee-8b4e-e063-6294a90a1a0a", "d6861b65-5f18-4217-91b5-132425791d90", "c159050a-e588-4091-b9ee-ea502e1b9529", "0e2ec613-5375-858e-e063-6294a90ab95a", "f9f54aa0-22e3-4958-b368-d89d716ac2fa", "50b4c21f-714a-4a01-bf28-a856b19914d1", "e78605b3-b28b-4634-9a58-d4bda67832ba", "f3766495-fce3-461c-8c95-e890f5e3383f", "ecdfccf3-58e8-47ce-89d3-53a4d3e3af21", "3960461c-958a-43c1-a685-522039b021df", "4f6846af-385e-b624-e063-6394a90a28d7", "01a705c0-0014-4a63-aa66-918cdcc2df67", "a675c4d7-bb27-4a92-8b10-dbae3a4ceb2b", "2ee49254-54a3-0865-e063-6294a90a2974", "e56ed9d9-cd5b-4ba2-82a3-eb805fbc1a5b", "0bef8406-8dab-0ad0-e063-6394a90a60d0", "504bf43e-4c28-4375-a6f4-285b2357f7f7", "e6815a98-0efc-4d69-8612-9e7ab7e78c0a", "9ebe158f-dd21-4bb8-ac13-d18162773cef", "faf81c5b-2d7e-4e6f-825b-f8a8399c0066", "f7b91231-4045-45a6-97c3-72fa9deaccf6", "0d039035-85d1-40d4-8ee6-540026ab7a5c", "ac83b4cd-5026-4dd5-b733-125d28ba3c95" ], "spl_set_id": [ "7e38318e-c569-4ad4-8f10-a235f30444d1", "fad0f147-6595-4412-87a7-2afca0192a96", "a6f89dc3-a594-4b5b-8728-272e20c1ecb5", "b0799e39-7b1e-430a-b159-062b39521001", "873fa936-157a-4f85-bc70-5df31d71d122", "29a5d098-bfa7-4a65-bb4f-5daa1fef1c2f", "4b805925-beb1-2bac-e054-00144ff88e88", "e9e47f3c-9acc-44f5-b0bd-d26fe9d35d64", "ee2e0da9-5ae7-405b-8dd1-635be72bc439", "33d4f4b4-bb4e-46af-9e89-df20154436d0", "ab162009-6f84-4d56-ab56-5e84409ec814", "e51a62ba-d163-4c57-835c-8c86cf097e40", "ee5a5a1d-63f6-4d5a-901b-65be45ec6610", "1ac38523-480b-4c0f-97a1-7dfa1432923c", "da0e8523-609a-4326-96b1-d7de78662d91", "11377169-7986-45b1-8298-6f0533efa3c3", "b6083405-9b45-4d2c-e053-2995a90ad9ef", "bb180ec5-1f75-43c1-9f63-c0657af2ca5f", "70269278-fe61-4800-a064-32cb6845cc28", "e12e2850-4980-48de-af58-15e559fb921f", "21a2bb1d-d91d-4f99-97dd-cc67fe99a090", "7dc8dfb1-dec8-43b3-b2ea-05eac054b2c6", "1bb4febd-0ed4-48c9-ba2a-e22183a2143f", "f299b2d2-86ed-4fb8-822e-65455a0bb75a", "d6178bc6-9dae-413f-8f47-de75d576c5b8", "86f6c19d-30d1-42e3-8d46-5e3f45776e85" ], "package_ndc": [ "71288-149-95", "71288-149-96", "72266-161-01", "72266-162-01", "68083-176-01", "68083-177-01", "68083-314-01", "31722-357-10", "31722-358-20", "71288-101-10", "71288-101-20", "25021-233-10", "25021-233-20", "16729-332-03", "16729-332-05", "16729-332-35", "67184-0501-1", "67184-0502-1", "71288-171-11", "71288-172-21", "67184-0508-1", "67184-0509-1", "67184-0510-1", "0781-3315-70", "0781-3317-80", "61703-363-18", "61703-363-22", "60505-6132-6", "60505-6132-7", "60505-6132-8", "42677-337-01", "42677-337-10", "42677-336-01", "42677-336-10", "67457-469-10", "67457-442-20", "71288-171-91", "71288-172-92", "68001-468-36", "68001-468-37", "60505-6287-2", "60505-6287-4", "0955-1731-10", "0955-1733-20", "63323-750-10", "63323-750-20", "43066-014-01", "43066-018-01", "72603-420-01", "72603-320-01", "55150-331-01", "55150-332-01", "72603-301-01", "72603-101-01", "68083-170-01", "68083-171-01", "0781-9315-70", "0781-9317-80" ], "nui": [ "N0000175413", "N0000175073" ], "pharm_class_epc": [ "Platinum-based Drug [EPC]" ], "unii": [ "04ZR38536J" ] } } ] } } ] }