{"effective_time":"20260406","id":"e0ce1921-cd6e-4663-acd0-ae34bd8222fa","openfda":{"application_number":["ANDA211582"],"brand_name":["Dapagliflozin"],"generic_name":["DAPAGLIFLOZIN"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000187059","N0000187058"],"package_ndc":["70771-1714-3","70771-1714-9","70771-1715-3","70771-1715-9"],"pharm_class_epc":["Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"],"pharm_class_moa":["Sodium-Glucose Transporter 2 Inhibitors [MoA]"],"product_ndc":["70771-1714","70771-1715"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["1488569","1488574"],"spl_id":["e0ce1921-cd6e-4663-acd0-ae34bd8222fa"],"spl_set_id":["db668c5c-2d49-41c8-8ffd-c2b2652b621a"],"substance_name":["DAPAGLIFLOZIN"],"unii":["1ULL0QJ8UC"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Dapagliflozin Tablets, 5 mg NDC 70771-1714-3 Bottles of 30 tablets Rx only Dapagliflozin Tablets, 10 mg NDC 70771-1715-3 Bottles of 30 tablets Rx only 5 mg 10 mg"],"set_id":"db668c5c-2d49-41c8-8ffd-c2b2652b621a","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["Dapagliflozin Dapagliflozin DAPAGLIFLOZIN DAPAGLIFLOZIN ANHYDROUS LACTOSE CROSPOVIDONE HYPROMELLOSE 2910 (3 MPA.S) MICROCRYSTALLINE CELLULOSE POLOXAMER 407 POLYETHYLENE GLYCOL 6000 SILICON DIOXIDE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE off-white 1380 Dapagliflozin Dapagliflozin DAPAGLIFLOZIN DAPAGLIFLOZIN ANHYDROUS LACTOSE CROSPOVIDONE HYPROMELLOSE 2910 (3 MPA.S) MICROCRYSTALLINE CELLULOSE POLOXAMER 407 POLYETHYLENE GLYCOL 6000 SILICON DIOXIDE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE off-white 1381"],"spl_unclassified_section":[""],"version":"6"}