{"effective_time":"20240812","id":"b7b4c7bb-e9d3-4441-a7d5-b949b1656e36","openfda":{"application_number":["ANDA209668"],"brand_name":["Teriflunomide"],"generic_name":["TERIFLUNOMIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000185502","N0000185501"],"package_ndc":["70771-1010-3","70771-1010-7","70771-1010-8","70771-1011-3","70771-1011-7","70771-1011-8"],"pharm_class_epc":["Pyrimidine Synthesis Inhibitor [EPC]"],"pharm_class_moa":["Dihydroorotate Dehydrogenase Inhibitors [MoA]"],"product_ndc":["70771-1010","70771-1011"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["1310525","1310533"],"spl_id":["b7b4c7bb-e9d3-4441-a7d5-b949b1656e36"],"spl_set_id":["58991a51-d40e-476f-8f5f-ac89e68e7107"],"substance_name":["TERIFLUNOMIDE"],"unii":["1C058IKG3B"],"upc":["0370710111533"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1010-3 Teriflunomide Tablets, 7 mg 30 Tablets Rx only NDC 70771-1011-3 Teriflunomide Tablets, 14 mg 30 Tablets Rx only 7 mg 14 mg"],"set_id":"58991a51-d40e-476f-8f5f-ac89e68e7107","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["Teriflunomide Teriflunomide TERIFLUNOMIDE TERIFLUNOMIDE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE WHITE TO OFF WHITE ROUND 1114 Teriflunomide Teriflunomide TERIFLUNOMIDE TERIFLUNOMIDE CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE BLUE TO LIGHT BLUE ROUND 1115"],"spl_unclassified_section":[""],"version":"3"}