<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43328-020-08
</NDCCode>
<PackageDescription>
8 POUCH in 1 CARTON (43328-020-08) / 1 FILM in 1 POUCH
</PackageDescription>
<NDC11Code>
43328-0020-08
</NDC11Code>
<ProductNDC>
43328-020
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sildenafil
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sildenafil Citrate
</NonProprietaryName>
<DosageFormName>
FILM
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260215
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA210858
</ApplicationNumber>
<LabelerName>
Altergon Italia srl
</LabelerName>
<SubstanceName>
SILDENAFIL CITRATE
</SubstanceName>
<StrengthNumber>
25
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-02-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260215
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>