{
"NDC": {
"NDCCode": "71863-119-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (71863-119-60) / 60 CAPSULE in 1 BOTTLE",
"NDC11Code": "71863-0119-60",
"ProductNDC": "71863-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitisinone",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Nitisinone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240115",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216201",
"LabelerName": "Eton Pharmaceuticals, Inc.",
"SubstanceName": "NITISINONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240115",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}