{
"NDC": {
"NDCCode": "71288-441-10",
"PackageDescription": "1 VIAL in 1 CARTON (71288-441-10) / 10 mL in 1 VIAL",
"NDC11Code": "71288-0441-10",
"ProductNDC": "71288-441",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desmopressin Acetate",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Desmopressin Acetate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20260213",
"EndMarketingDate": null,
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074888",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "DESMOPRESSIN ACETATE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260213",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}