<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68084-965-19
</NDCCode>
<PackageDescription>
20 BLISTER PACK in 1 CARTON (68084-965-19) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-965-18)
</PackageDescription>
<NDC11Code>
68084-0965-19
</NDC11Code>
<ProductNDC>
68084-965
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Valganciclovir
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Valganciclovir
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20150107
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA203511
</ApplicationNumber>
<LabelerName>
American Health Packaging
</LabelerName>
<SubstanceName>
VALGANCICLOVIR HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
450
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-09-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240922
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>