{
"NDC": {
"NDCCode": "80725-810-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10) ",
"NDC11Code": "80725-0810-10",
"ProductNDC": "80725-810",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrea",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Hydroxyurea",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250911",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016295",
"LabelerName": "Waylis Therapeutics LLC",
"SubstanceName": "HYDROXYUREA",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite [EPC], Urea [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250911",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}