<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42571-477-47
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (42571-477-47) / 100 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
42571-0477-47
</NDC11Code>
<ProductNDC>
42571-477
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Valganciclovir
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Valganciclovir
</NonProprietaryName>
<DosageFormName>
POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260601
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218838
</ApplicationNumber>
<LabelerName>
Micro Labs Limited
</LabelerName>
<SubstanceName>
VALGANCICLOVIR HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/mL
</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>
2026-06-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260601
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>