{"effective_time":"20241028","id":"996040a7-8eaa-4dcc-ba36-5c37d4db8113","indications_and_usage":["INDICATIONS AND USAGE Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction."],"openfda":{"application_number":["ANDA203521"],"brand_name":["Tranexamic Acid"],"generic_name":["TRANEXAMIC ACID"],"is_original_packager":[true],"manufacturer_name":["Emcure Pharmaceuticals Limited"],"nui":["N0000175634","N0000175632"],"package_ndc":["14593-318-01"],"pharm_class_epc":["Antifibrinolytic Agent [EPC]"],"pharm_class_pe":["Decreased Fibrinolysis [PE]"],"product_ndc":["14593-318"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"rxcui":["238720"],"spl_id":["996040a7-8eaa-4dcc-ba36-5c37d4db8113"],"spl_set_id":["ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a"],"substance_name":["TRANEXAMIC ACID"],"unii":["6T84R30KC1"],"upc":["0314593318016"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 14593-318-01 Tranexamic Acid Injection, USP 1000 mg/10 mL (100 mg/mL) Intravenous Use Only Rx only 10 mL Single-Dose Vial label"],"set_id":"ceea739a-21dd-4c3a-9ef6-2b7ab2bdd95a","spl_product_data_elements":["Tranexamic Acid Tranexamic Acid TRANEXAMIC ACID TRANEXAMIC ACID WATER"],"version":"1"}