{
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"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (67046-1619-3) ",
"NDC11Code": "67046-1619-03",
"ProductNDC": "67046-1619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyurea",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Hydroxyurea",
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"RouteName": "ORAL",
"StartMarketingDate": "20251202",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218021",
"LabelerName": "Coupler LLC",
"SubstanceName": "HYDROXYUREA",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite [EPC], Urea [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251202",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}