{
"NDC": {
"NDCCode": "78206-193-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (78206-193-01) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "78206-0193-01",
"ProductNDC": "78206-193",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bildyos",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Denosumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250911",
"EndMarketingDate": null,
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761444",
"LabelerName": "Organon LLC",
"SubstanceName": "DENOSUMAB",
"StrengthNumber": "60",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250911",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}