{
"NDC": {
"NDCCode": "50580-754-35",
"PackageDescription": "1 BOTTLE in 1 CARTON (50580-754-35) / 35 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50580-0754-35",
"ProductNDC": "50580-754",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zyrtec Allergy",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250215",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019835",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250215",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}