<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0527-6010-06
</NDCCode>
<PackageDescription>
1 INHALER in 1 CARTON (0527-6010-06) / 60 POWDER in 1 INHALER
</PackageDescription>
<NDC11Code>
00527-6010-06
</NDC11Code>
<ProductNDC>
0527-6010
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Fluticasone Propionate And Salmeterol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fluticasone Propionate And Salmeterol
</NonProprietaryName>
<DosageFormName>
POWDER
</DosageFormName>
<RouteName>
RESPIRATORY (INHALATION)
</RouteName>
<StartMarketingDate>
20260112
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214464
</ApplicationNumber>
<LabelerName>
Lannett Company, Inc.
</LabelerName>
<SubstanceName>
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
</SubstanceName>
<StrengthNumber>
100; 50
</StrengthNumber>
<StrengthUnit>
ug/1; ug/1
</StrengthUnit>
<Pharm_Classes>
Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260112
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>