<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0517-2901-01
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
00517-2901-01
</NDC11Code>
<ProductNDC>
0517-2901
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Gvoke Vialdx
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glucagon Injection
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250819
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA212097
</ApplicationNumber>
<LabelerName>
American Regent, Inc.
</LabelerName>
<SubstanceName>
GLUCAGON
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/.2mL
</StrengthUnit>
<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]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250819
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>