{
"NDC": {
"NDCCode": "83198-202-81",
"PackageDescription": "1 POWDER, FOR SOLUTION in 1 POUCH (83198-202-81) ",
"NDC11Code": "83198-0202-81",
"ProductNDC": "83198-202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sapropterin Dihydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Sapropterin Dihydrochloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20240130",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216432",
"LabelerName": "Hopewell Pharma Ventures, Inc.",
"SubstanceName": "SAPROPTERIN DIHYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Phenylalanine Hydroxylase Activator [EPC], Phenylalanine Hydroxylase Activators [MoA]",
"DEASchedule": null,
"Status": "Deprecated",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240130",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}