<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82546-200-09
</NDCCode>
<PackageDescription>
9 BLISTER PACK in 1 CARTON (82546-200-09) / 1 TABLET, COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
82546-0200-09
</NDC11Code>
<ProductNDC>
82546-200
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pivya
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pivmecillinam
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250531
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA216483
</ApplicationNumber>
<LabelerName>
UTILITY therapeutics Ltd
</LabelerName>
<SubstanceName>
PIVMECILLINAM HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
185
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2025-06-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250531
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>