{
"NDC": {
"NDCCode": "84386-085-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (84386-085-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "84386-0085-03",
"ProductNDC": "84386-085",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perampanel",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20261002",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220492",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261002",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}