<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0173-0922-38
</NDCCode>
<PackageDescription>
8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38)
</PackageDescription>
<NDC11Code>
00173-0922-38
</NDC11Code>
<ProductNDC>
0173-0922
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Blujepa
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Gepotidacin
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250325
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA218230
</ApplicationNumber>
<LabelerName>
GlaxoSmithKline LLC
</LabelerName>
<SubstanceName>
GEPOTIDACIN MESYLATE
</SubstanceName>
<StrengthNumber>
750
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Cholinesterase Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Topoisomerase 2 Inhibitors [MoA], Topoisomerase 4 Inhibitors [MoA], Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251211
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>