{"effective_time":"20220826","id":"6908877d-222b-43e6-a7e9-f264fae84be4","openfda":{"application_number":["ANDA215234"],"brand_name":["FULVESTRANT"],"generic_name":["FULVESTRANT"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175582","N0000000145","N0000000168"],"package_ndc":["70771-1626-2","70771-1626-8"],"pharm_class_epc":["Estrogen Receptor Antagonist [EPC]"],"pharm_class_moa":["Estrogen Receptor Antagonists [MoA]","Selective Estrogen Receptor Modulators [MoA]"],"product_ndc":["70771-1626"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["INTRAMUSCULAR"],"rxcui":["727762"],"spl_id":["6908877d-222b-43e6-a7e9-f264fae84be4"],"spl_set_id":["151b948a-3106-497a-b1c7-479307faeb89"],"substance_name":["FULVESTRANT"],"unii":["22X328QOC4"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1626-2 Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Both single-dose prefilled syringes must be administered to receive the 500 mg dose. PROTECT FROM LIGHT Rx only Made in India NDC 70771-1626-8 Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only This carton contains a total of 500 mg fulvestrant in TWO single-dose prefilled syringes each containing 250 mg/5 mL, and two Safety Glide™ shielding intramuscular injection needles. Discard each syringe after use. Both single-dose prefilled syringes must be administered to receive the 500 mg dose. STORAGE: REFRIGERATE 2° to 8°C (36° to 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE. Contains 2 Single-Dose Prefilled Syringes Rx only pfs mfg label carton mfg label"],"set_id":"151b948a-3106-497a-b1c7-479307faeb89","spl_product_data_elements":["FULVESTRANT fulvestrant FULVESTRANT FULVESTRANT ALCOHOL BENZYL ALCOHOL BENZYL BENZOATE CASTOR OIL"],"spl_unclassified_section":[""],"version":"2"}