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<NDC>
<NDCCode>
67386-130-91
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (67386-130-91) / 1 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
67386-0130-91
</NDC11Code>
<ProductNDC>
67386-130
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Vyepti
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Eptinezumab-jjmr
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20200221
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761119
</ApplicationNumber>
<LabelerName>
Lundbeck Pharmaceuticals LLC
</LabelerName>
<SubstanceName>
EPTINEZUMAB
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Calcitonin Gene-related Peptide Antagonist [EPC], Calcitonin Gene-related Peptide Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20230401
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
Y
</SamplePackage>
</NDC>