<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
59676-577-30
</NDCCode>
<PackageDescription>
30 TABLET, FOR SUSPENSION in 1 BOTTLE (59676-577-30)
</PackageDescription>
<NDC11Code>
59676-0577-30
</NDC11Code>
<ProductNDC>
59676-577
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Prezcobix Ped
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Darunavir Ethanolate And Cobicistat
</NonProprietaryName>
<DosageFormName>
TABLET, FOR SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260227
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA220092
</ApplicationNumber>
<LabelerName>
Janssen Products, LP
</LabelerName>
<SubstanceName>
DARUNAVIR ETHANOLATE; COBICISTAT
</SubstanceName>
<StrengthNumber>
90; 600
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-08-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260227
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>