{ "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. 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"spl_set_id": [ "f56aec67-c662-477c-b866-bfc23e8809cf" ], "package_ndc": [ "47783-101-01" ], "nui": [ "N0000192750", "N0000184151" ], "pharm_class_epc": [ "Plasma Kallikrein Inhibitor [EPC]" ], "pharm_class_moa": [ "Kallikrein Inhibitors [MoA]" ], "unii": [ "5Q6TZN2HNM" ] } }, { "drugcharacterization": "1", "medicinalproduct": "KALBITOR", "drugauthorizationnumb": "125277", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugdosagetext": "30 MILLIGRAM", "drugdosageform": "Solution for injection", "actiondrug": "4", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "ECALLANTIDE" }, "openfda": { "application_number": [ "BLA125277" ], "brand_name": [ "KALBITOR" ], "generic_name": [ "ECALLANTIDE" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "47783-101" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ECALLANTIDE" ], "rxcui": [ "884698", "884702" ], "spl_id": [ "1992039f-246f-4057-899b-987d45df152f" ], "spl_set_id": [ "f56aec67-c662-477c-b866-bfc23e8809cf" ], "package_ndc": [ "47783-101-01" ], "nui": [ "N0000192750", "N0000184151" ], "pharm_class_epc": [ "Plasma Kallikrein Inhibitor [EPC]" ], "pharm_class_moa": [ "Kallikrein Inhibitors [MoA]" ], "unii": [ "5Q6TZN2HNM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ICATIBANT ACETATE", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "activesubstance": { "activesubstancename": "ICATIBANT ACETATE" }, "openfda": { "application_number": [ "NDA022150" ], "brand_name": [ "FIRAZYR" ], "generic_name": [ "ICATIBANT ACETATE" ], "manufacturer_name": [ "Takeda Pharmaceuticals America, Inc." ], "product_ndc": [ "54092-702" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ICATIBANT ACETATE" ], "rxcui": [ "1148141", "1148145" ], "spl_id": [ "19b83a10-9f38-4d0d-ae46-0f5b28168873" ], "spl_set_id": [ "ed6657ca-ab68-477a-9968-e12dc928b540" ], "package_ndc": [ "54092-702-02", "54092-702-03", "54092-702-01" ], "unii": [ "325O8467XK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "EPINEPHRINE", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "EPINEPHRINE" }, "openfda": { "application_number": [ "ANDA217192", "NDA211363", "ANDA211880", "NDA220626", "ANDA219239", "NDA204640", "NDA205029", "ANDA217485", "NDA019430", "ANDA218144", "NDA215425", "NDA020800", "NDA218475", "NDA214697", "ANDA213708", "ANDA207568", "ANDA218208", "NDA201739", "NDA204200", "ANDA220562", "ANDA090589" ], "brand_name": [ "EPINEPHRINE", "EPINEPHRINE 1553", "ADRENALIN", "EPIPEN", "EPIPEN JR", "NEFFY", "ADRENALINUM", "AUVI-Q" ], "generic_name": [ "EPINEPHRINE", "ADRENALINUM" ], "manufacturer_name": [ "American Regent, Inc.", "Professional Complementary Health Formulas", "International Medication Systems, Limited", "Baxter Healthcare Corporation", "Gland Pharma Limited", "Par Health USA, LLC", "BPI Labs, LLC", "Amneal Pharmaceuticals LLC", "Viatris Specialty LLC", "GLENMARK PHARMACEUTICALS INC., USA", "Fresenius Kabi USA, LLC", "Deseret Biologicals, Inc.", "Amneal Pharmaceuticals of New York LLC", "ARS Pharmaceuticals Operations, Inc.", "Boiron", "Amneal Pharmaceuticals Private Limited", "kaleo, Inc", "Hikma Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc.", "CIVICA, INC." ], "product_ndc": [ "0517-3030", "63083-1553", "76329-3318", "76329-9060", "43066-801", "43066-803", "68083-633", "68083-685", "42023-168", "54288-119", "54288-120", "54288-152", "70121-1660", "49502-500", "49502-501", "68462-933", "68083-591", "63323-698", "43742-1243", "0115-1694", "0115-1695", "0338-0006", "0338-0024", "82580-010", "82580-020", "63323-696", "54288-103", "0517-1171", "0220-0078", "80830-1659", "60842-021", "60842-023", "60842-022", "68462-760", "68462-761", "42023-159", "54288-117", "54288-600", "0220-0076", "0143-9476", "0093-5985", "0093-5986", "72572-238", "49502-101", "49502-102" ], "product_type": [ "HUMAN PRESCRIPTION DRUG", "HUMAN OTC DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "ORAL", "INTRAOCULAR", "NASAL" ], "substance_name": [ "EPINEPHRINE", "EPINEPHRINE BITARTRATE" ], "rxcui": [ "310132", "727373", "1660014", "1490057", "727316", "727347", "727386", "1870207", "1870225", "1870230", "2695029", "2707568", "2693442", "2693448", "2709207", "2709209", "1305268", "1305269", "1870205", "1870232", "1991328", "1991329", "1660016", "2637533" ], "spl_id": [ "495f1aad-cf64-41ab-9f9e-59f6ebeb44aa", "45ccdc05-7de3-4a1b-a2c9-274a39b0db41", "fde15adc-52e9-4f6e-8437-5a450934b280", "79307d47-34e5-4073-a52d-ee1404727a97", "ef556382-9d19-4f0e-9dbe-fcecc772a3e2", "a7f9fba5-54b0-4001-ba9b-86468e159db7", "949de41f-6427-4b8d-bb4b-c2dab1436309", "cb28673a-ca0d-498d-94c4-cc2f34c3108b", "b142feb8-f509-4fab-90ad-824623d0301e", 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"3b7a4364-668d-4eb2-a20c-04adc35aabe4", "7499cbca-b8fe-4fc3-a318-13859ab989a7", "3fd8dd51-0aeb-43dd-9de0-c11b0330b15e", "83fa46ed-ce86-5054-e053-2991aa0ab381", "1e8ebac1-5b32-47f9-a930-86a98a24dccc", "04f07f15-55e2-411b-abb8-07eab37f5664", "4a79ad00-405b-4454-a692-7f1daac4adec", "778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836" ], "package_ndc": [ "0517-3030-01", "63083-1553-1", "76329-3318-1", "76329-9060-0", "43066-803-01", "43066-803-25", "43066-801-01", "43066-801-02", "68083-633-01", "68083-685-01", "42023-168-99", "54288-120-01", "54288-119-10", "54288-119-25", "54288-152-01", "70121-1660-2", "49502-500-01", "49502-500-02", "49502-500-92", "49502-501-01", "49502-501-02", "49502-501-92", "68462-933-01", "68462-933-10", "42023-168-89", "68083-591-10", "63323-698-30", "43742-1243-1", "0115-1695-30", "0115-1695-49", "0115-1694-30", "0115-1694-49", "0338-0006-20", "0338-0024-20", "82580-020-02", "82580-010-02", "63323-696-02", "63323-696-25", "54288-103-10", "0517-1171-01", "0517-1171-10", "0220-0078-41", "80830-1659-1", "80830-1659-2", "60842-023-02", "60842-023-01", "60842-022-02", "60842-022-01", "60842-021-02", "60842-021-01", "68462-760-10", "68462-761-30", "42023-159-01", "42023-159-25", "42023-168-01", "54288-117-01", "54288-117-10", "54288-600-01", "0220-0076-41", "0143-9476-01", "0143-9476-25", "0093-5986-19", "0093-5986-27", "0093-5985-19", "0093-5985-27", "72572-238-01", "49502-102-01", "49502-102-02", "49502-101-01", "49502-101-02" ], "nui": [ "N0000000209", "N0000000245", "N0000175552", "N0000175555", "N0000175570", "M0003647" ], "pharm_class_moa": [ "Adrenergic alpha-Agonists [MoA]", "Adrenergic beta-Agonists [MoA]" ], "pharm_class_epc": [ "alpha-Adrenergic Agonist [EPC]", "beta-Adrenergic Agonist [EPC]", "Catecholamine [EPC]" ], "pharm_class_cs": [ "Catecholamines [CS]" ], "unii": [ "YKH834O4BH", "30Q7KI53AK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ANDEMBRY", "drugseparatedosagenumb": "1", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "GARADACIMAB-GXII" }, "openfda": { "application_number": [ "BLA761367" ], "brand_name": [ "ANDEMBRY" ], "generic_name": [ "GARADACIMAB" ], "manufacturer_name": [ "CSL" ], "product_ndc": [ "63833-925" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "GARADACIMAB" ], "rxcui": [ "2717175", "2717182" ], "spl_id": [ "a15c0e04-117a-434d-8b34-b664701b787f" ], "spl_set_id": [ "07b0b671-db81-49f0-a402-0c0219db7fa2" ], "package_ndc": [ "63833-925-20", "63833-925-01" ], "unii": [ "32W6AJL0DY" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ANDEMBRY", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "802", "drugdosagetext": "UNK UNK, MONTHLY", "activesubstance": { "activesubstancename": "GARADACIMAB-GXII" }, "openfda": { "application_number": [ "BLA761367" ], "brand_name": [ "ANDEMBRY" ], "generic_name": [ "GARADACIMAB" ], "manufacturer_name": [ "CSL" ], "product_ndc": [ "63833-925" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "GARADACIMAB" ], "rxcui": [ "2717175", "2717182" ], "spl_id": [ "a15c0e04-117a-434d-8b34-b664701b787f" ], "spl_set_id": [ "07b0b671-db81-49f0-a402-0c0219db7fa2" ], "package_ndc": [ "63833-925-20", "63833-925-01" ], "unii": [ "32W6AJL0DY" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20250108" } } } ] }