<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68094-073-58
</NDCCode>
<PackageDescription>
50 BAG in 1 CASE (68094-073-58) / 1 SYRINGE, PLASTIC in 1 BAG / 5 mL in 1 SYRINGE, PLASTIC (68094-073-01)
</PackageDescription>
<NDC11Code>
68094-0073-58
</NDC11Code>
<ProductNDC>
68094-073
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Glycopyrrolate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycopyrrolate
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250707
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA204438
</ApplicationNumber>
<LabelerName>
Precision Dose, Inc.
</LabelerName>
<SubstanceName>
GLYCOPYRROLATE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250707
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>