<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
66993-189-97
</NDCCode>
<PackageDescription>
1 TRAY in 1 CARTON (66993-189-97) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER
</PackageDescription>
<NDC11Code>
66993-0189-97
</NDC11Code>
<ProductNDC>
66993-189
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Umeclidinium Ellipta
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Umeclidinium
</NonProprietaryName>
<DosageFormName>
AEROSOL, POWDER
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260406
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA205382
</ApplicationNumber>
<LabelerName>
Prasco Laboratories
</LabelerName>
<SubstanceName>
UMECLIDINIUM BROMIDE
</SubstanceName>
<StrengthNumber>
62.5
</StrengthNumber>
<StrengthUnit>
ug/1
</StrengthUnit>
<Pharm_Classes>
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-04-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260406
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>