{"effective_time":"20220505","id":"a7ff2205-566b-4fb5-8f33-bf73377ee093","openfda":{"application_number":["ANDA210204"],"brand_name":["BORTEZOMIB"],"generic_name":["BORTEZOMIB"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175604","N0000175075"],"package_ndc":["70771-1708-1"],"pharm_class_epc":["Proteasome Inhibitor [EPC]"],"pharm_class_moa":["Proteasome Inhibitors [MoA]"],"product_ndc":["70771-1708"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAVENOUS","SUBCUTANEOUS"],"rxcui":["402243"],"spl_id":["a7ff2205-566b-4fb5-8f33-bf73377ee093"],"spl_set_id":["582c7c0d-fa25-4586-8157-a1e2653d72d9"],"substance_name":["BORTEZOMIB"],"unii":["69G8BD63PP"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1708-1 Bortezomib for Injection 3.5 mg/vial For Intravenous or Subcutaneous Use One Single-dose Vial Rx only NDC 70771-1708-1 Bortezomib for Injection – Carton label 3.5 mg/vial For Intravenous or Subcutaneous Use Reconstitution Information SUBCUTANEOUS INJECTION ONLY 0.9% NaCl Add 1.4 mL 0.9% Sodium Chloride To make 2.5 mg/mL final concentration INTRAVENOUS INJECTION ONLY 0.9% NaCl Add 3.5 mL 0.9% Sodium Chloride To make 1 mg/mL final concentration One Single-dose Vial Rx only Reconstitution Information – Inside Flap (All cartons) SUBCUTANEOUS INJECTION ONLY 0.9% NaCl Add 1.4 mL 0.9% Sodium Chloride To make 2.5 mg/mL final concentration INTRAVENOUS INJECTION ONLY 0.9% NaCl Add 3.5 mL 0.9% Sodium Chloride To make 1 mg/mL final concentration vial label carton label Inside Flap image"],"set_id":"582c7c0d-fa25-4586-8157-a1e2653d72d9","spl_product_data_elements":["BORTEZOMIB BORTEZOMIB BORTEZOMIB BORTEZOMIB MANNITOL"],"spl_unclassified_section":["SPL UNCLASSIFIED"],"version":"1"}