<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
12516-4600-1
</NDCCode>
<PackageDescription>
320 POUCH in 1 BOX (12516-4600-1) / 2 INHALER in 1 POUCH / 120 AEROSOL, METERED in 1 INHALER
</PackageDescription>
<NDC11Code>
12516-4600-01
</NDC11Code>
<ProductNDC>
12516-4600
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycopyrrolate And Formoterol Fumarate
</NonProprietaryName>
<DosageFormName>
AEROSOL, METERED
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20161003
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Bespak HC Limited
</LabelerName>
<SubstanceName>
FORMOTEROL FUMARATE; GLYCOPYRROLATE
</SubstanceName>
<StrengthNumber>
4.8; 9
</StrengthNumber>
<StrengthUnit>
ug/1; ug/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-12-31
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
03-OCT-16
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>