<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70069-431-05
</NDCCode>
<PackageDescription>
5 VIAL in 1 CARTON (70069-431-05) / 2 mL in 1 VIAL (70069-431-01)
</PackageDescription>
<NDC11Code>
70069-0431-05
</NDC11Code>
<ProductNDC>
70069-431
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dicyclomine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dicyclomine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR
</RouteName>
<StartMarketingDate>
20241105
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214332
</ApplicationNumber>
<LabelerName>
Somerset Therapeutics, LLC
</LabelerName>
<SubstanceName>
DICYCLOMINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-11-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241105
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>