<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0121-1102-55
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (0121-1102-55) / 300 mg in 1 VIAL
</PackageDescription>
<NDC11Code>
00121-1102-55
</NDC11Code>
<ProductNDC>
0121-1102
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pentamidine Isethionate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pentamidine Isethionate
</NonProprietaryName>
<DosageFormName>
INHALANT
</DosageFormName>
<RouteName>
RESPIRATORY (INHALATION)
</RouteName>
<StartMarketingDate>
20260612
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA206667
</ApplicationNumber>
<LabelerName>
PAI Holdings, LLC dba PAI Pharma
</LabelerName>
<SubstanceName>
PENTAMIDINE DIISETHIONATE
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/300mg
</StrengthUnit>
<Pharm_Classes>
Antiprotozoal [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-06-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260612
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>