{"effective_time":"20241025","id":"c45924d5-c45b-4f31-afa5-0cbc090d2816","openfda":{"application_number":["ANDA078877"],"brand_name":["topiramate"],"generic_name":["TOPIRAMATE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000008486","N0000185506","N0000182140"],"package_ndc":["65841-651-14","65841-651-16","65841-651-01","65841-651-05","65841-651-10","65841-652-17","65841-652-14","65841-652-16","65841-652-01","65841-652-05","65841-652-10","65841-846-14"],"pharm_class_moa":["Cytochrome P450 3A4 Inducers [MoA]","Cytochrome P450 2C19 Inhibitors [MoA]"],"pharm_class_pe":["Decreased Central Nervous System Disorganized Electrical Activity [PE]"],"product_ndc":["65841-651","65841-652","65841-846"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["205315","205316","252413"],"spl_id":["c45924d5-c45b-4f31-afa5-0cbc090d2816"],"spl_set_id":["6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b"],"substance_name":["TOPIRAMATE"],"unii":["0H73WJJ391"],"upc":["0368382005144","0368382004147"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-651-14 in bottle of 60 capsules Topiramate Capsules USP, 15 mg 60 capsules Rx only NDC 65841-652-14 in bottle of 60 capsules Topiramate Capsules USP, 25 mg 60 capsules Rx only NDC 65841-100-14 in bottle of 60 capsules Topiramate Capsules USP, 50 mg 60 capsules Rx only Topiramate Capsules (Sprinkle), 15 mg Topiramate Capsules (Sprinkle), 25 mg 50 mg label"],"set_id":"6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WATER FERROSOFERRIC OXIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC WHITE CAPSULE ZA63;15mg topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WATER FERROSOFERRIC OXIDE SHELLAC POTASSIUM HYDROXIDE PROPYLENE GLYCOL WHITE CAPSULE ZA64;25mg topiramate topiramate TOPIRAMATE TOPIRAMATE HYPROMELLOSES CELLULOSE ACETATE GELATIN POVIDONE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE WATER PROPYLENE GLYCOL POTASSIUM HYDROXIDE SHELLAC FERROSOFERRIC OXIDE WHITE CAPSULE 50mg"],"version":"11"}