{"effective_time":"20171204","id":"c25575a4-1e28-4d35-8acf-2e2d8743be37","openfda":{},"package_label_principal_display_panel":["PRINCIPLE DISPLAY PANEL NDC 49401-101-01 Benlysta ® (belimumab) for Injection 120 mg/vial For Intravenous Infusion after dilution only. Single-dose vial. Discard unused portion Reconstitution: Reconstitute with 1.5 mL of Sterile Water for Injection, USP. After reconstitution, the concentration of BENLYSTA is 80 mg/mL. Dilute: Further dilute in 250 mL of one of the following solutions before use: • 0.9% Sodium Chloride Injection, USP • 0.45% Sodium Chloride Injection, USP • Lactated Ringer’s Injection, USP Federal Law requires dispensing of BENLYSTA ® with the Medication Guide provided with this carton. Rx only ©2016 the GSK group of companies Rev. 6/16 10000000141921 Benlysta 120 mg per vial carton","PRINCIPAL DISPLAY PANEL NDC 49401-102-01 Benlysta ® (belimumab) for Injection 400 mg/vial For Intravenous Infusion after dilution only. Single-dose vial. Discard unused portion Reconstitution: Reconstitute with 4.8 mL of Sterile Water for Injection, USP. After reconstitution, the concentration of BENLYSTA is 80 mg/mL. Dilute: Further dilute in 250 mL of one of the following solutions before use: • 0.9% Sodium Chloride Injection, USP • 0.45% Sodium Chloride Injection, USP • Lactated Ringer’s Injection, USP Federal Law requires dispensing of BENLYSTA ® with the Medication Guide provided with this carton. Rx only ©2016 the GSK group of companies Rev. 7/16 10000000141890 Benlysta 400 mg per vial carton"],"set_id":"6fbb0330-d529-4cce-9b4a-006a89e30c6a","spl_product_data_elements":["BENLYSTA belimumab BELIMUMAB BELIMUMAB SODIUM CITRATE, UNSPECIFIED FORM POLYSORBATE 80 CITRIC ACID MONOHYDRATE SUCROSE BENLYSTA belimumab BELIMUMAB BELIMUMAB CITRIC ACID MONOHYDRATE SODIUM CITRATE, UNSPECIFIED FORM SUCROSE POLYSORBATE 80"],"version":"3"}