<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0173-0956-76
</NDCCode>
<PackageDescription>
10 BLISTER PACK in 1 CARTON (0173-0956-76) / 8 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
00173-0956-76
</NDC11Code>
<ProductNDC>
0173-0956
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Utebzi
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Tebipenem Pivoxil
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20261001
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA215960
</ApplicationNumber>
<LabelerName>
GlaxoSmithKline LLC
</LabelerName>
<SubstanceName>
TEBIPENEM PIVOXIL HYDROBROMIDE
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-10-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20261001
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>