{
"NDC": {
"NDCCode": "70954-912-10",
"PackageDescription": "473 mL in 1 BOTTLE (70954-912-10) ",
"NDC11Code": "70954-0912-10",
"ProductNDC": "70954-912",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260115",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219648",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260115",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}