{
"NDC": {
"NDCCode": "0517-2901-10",
"PackageDescription": "10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL",
"NDC11Code": "00517-2901-10",
"ProductNDC": "0517-2901",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gvoke Vialdx",
"ProprietaryNameSuffix": null,
"NonProprietaryName": "Glucagon Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250819",
"EndMarketingDate": null,
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212097",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "GLUCAGON",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]",
"DEASchedule": null,
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250819",
"EndMarketingDatePackage": null,
"SamplePackage": "N"
}
}