{"effective_time":"20230928","id":"432dc54b-f28b-48c9-b417-2fbae070f41b","openfda":{"application_number":["ANDA208949"],"brand_name":["Topiramate"],"generic_name":["TOPIRAMATE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000008486","N0000185506","N0000182140"],"package_ndc":["70771-1656-9","70771-1656-3","70771-1657-3","70771-1657-9","70771-1658-3","70771-1658-9","70771-1659-3","70771-1659-9","70771-1660-3","70771-1660-9"],"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":["70771-1656","70771-1657","70771-1658","70771-1659","70771-1660"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["1494769","1812419","1812421","1812425","1812427"],"spl_id":["432dc54b-f28b-48c9-b417-2fbae070f41b"],"spl_set_id":["57b5d67b-b29b-4c18-a53d-51d5374f3be3"],"substance_name":["TOPIRAMATE"],"unii":["0H73WJJ391"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1656-3 Topiramate extended-release Capsules 25 mg Rx only 30 Capsules NDC 70771-1657-3 Topiramate extended-release Capsules 50 mg Rx only 30 Capsules NDC 70771-1658-3 Topiramate extended-release Capsules 100 mg Rx only 30 Capsules NDC 70771-1659-3 Topiramate extended-release Capsules 150 mg Rx only 30 Capsules NDC 70771-1660-3 Topiramate extended-release Capsules 200 mg Rx only 30 Capsules 25 mg label 50 mg label 100 mg label 150 mg label 200 mg label"],"set_id":"57b5d67b-b29b-4c18-a53d-51d5374f3be3","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER FLESH OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1039 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER IVORY OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1040 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER MEDIUM ORANGE OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1041 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER WHITE OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1042 Topiramate Topiramate TOPIRAMATE TOPIRAMATE ETHYLCELLULOSE (10 MPA.S) ETHYLCELLULOSE (45 MPA.S) FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED HYPROMELLOSE 2910 (15 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE WATER LIGHT GREEN OPAQUE CAP WHITE OPAQUE BODY CAPSULE 1043"],"spl_unclassified_section":[""],"version":"3"}