{"effective_time":"20260126","id":"494dbaab-6ded-549d-e063-6394a90a4022","openfda":{"application_number":["NDA201532"],"brand_name":["Halaven"],"generic_name":["ERIBULIN MESYLATE"],"is_original_packager":[true],"manufacturer_name":["BSP Pharmaceuticals SpA"],"package_ndc":["43624-002-01"],"product_ndc":["43624-002"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS"],"rxcui":["1045456","1045460"],"spl_id":["494dbaab-6ded-549d-e063-6394a90a4022"],"spl_set_id":["8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6"],"substance_name":["ERIBULIN MESYLATE"],"unii":["AV9U0660CW"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - SHIPPER LABEL Eisai Manufacturing Limited ​Allegato DQA-035/XXXX​ New Chemical Entity Demand Chain Unit European Knowledge Centre Mosquito Way-Hatfield, Herts, AL 109SN United Kingdom ​​ HALAVEN® (eribulin mesylate) Injection, for intravenous use- 0.5mg/ml, 2 ml Store at 15° - 25°C (59° - 77°F). DO NOT FREEZE QTY: 00XXX EXP: MM-YYYY LOT: F1XXYZZZ (22) 900XXX MMYYYY F1XXYZZZ 7 NDC 43624-002-01 ( 0X) 50X XXXXX 00X X X0 XXX Manufactured by : BSP Pharmaceuticals SpA-Latina Scalo, Italy. ​ Image (eribulin mesylate) Injection1 mg/2 mL(0.5 mg/mL)For Intravenous Use"],"set_id":"8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6","spl_product_data_elements":["Halaven eribulin mesylate WATER ERIBULIN MESYLATE ERIBULIN ALCOHOL clear, colorless, sterile solution for intravenous administration"],"spl_unclassified_section":["Halaven® (eribulin mesylate) Injection, for intravenous use 1 mg/2 mL (0.5 mg/mL)"],"version":"58"}