<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0074-0501-01
</NDCCode>
<PackageDescription>
7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSE
</PackageDescription>
<NDC11Code>
00074-0501-01
</NDC11Code>
<ProductNDC>
0074-0501
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Vyalev
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Foscarbidopa/foslevodopa
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20220412
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA216962
</ApplicationNumber>
<LabelerName>
AbbVie Inc.
</LabelerName>
<SubstanceName>
FOSCARBIDOPA; FOSLEVODOPA
</SubstanceName>
<StrengthNumber>
12; 240
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-10-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220412
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>