{"effective_time":"20241204","id":"5adaa941-43ea-41a8-944f-598d38132c99","openfda":{"application_number":["ANDA211567"],"brand_name":["Ramelteon"],"generic_name":["RAMELTEON"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175743","N0000000250"],"package_ndc":["70771-1495-3","70771-1495-1","70771-1495-5"],"pharm_class_epc":["Melatonin Receptor Agonist [EPC]"],"pharm_class_moa":["Melatonin Receptor Agonists [MoA]"],"product_ndc":["70771-1495"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["577348"],"spl_id":["5adaa941-43ea-41a8-944f-598d38132c99"],"spl_set_id":["14ba7994-476a-4978-8cac-29989335a63c"],"substance_name":["RAMELTEON"],"unii":["901AS54I69"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1495-3 Ramelteon Tablets, 8 mg 30 Tablets Rx only Ramelteon Tablets"],"set_id":"14ba7994-476a-4978-8cac-29989335a63c","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["Ramelteon Ramelteon RAMELTEON RAMELTEON ANHYDROUS LACTOSE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYPROMELLOSE 2910 (3 MPA.S) POLYETHYLENE GLYCOL 6000 POVIDONE SILICON DIOXIDE SODIUM STEARYL FUMARATE STARCH, CORN TITANIUM DIOXIDE light yellow to beige coloured 1344"],"spl_unclassified_section":[""],"version":"6"}