{
"NDC": {
"NDCCode": "70710-2180-8",
"PackageDescription": "1 BOTTLE in 1 CARTON (70710-2180-8) / 250 TABLET in 1 BOTTLE",
"NDC11Code": "70710-2180-08",
"ProductNDC": "70710-2180",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Phenylbutyrate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Sodium Phenylbutyrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220418",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "SODIUM PHENYLBUTYRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}