<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70069-641-25
</NDCCode>
<PackageDescription>
25 VIAL in 1 CARTON (70069-641-25) / 1 mL in 1 VIAL (70069-641-01)
</PackageDescription>
<NDC11Code>
70069-0641-25
</NDC11Code>
<ProductNDC>
70069-641
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Atropine Sulfate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Atropine Sulfate
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20240704
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA215969
</ApplicationNumber>
<LabelerName>
Somerset Therapeutics, LLC
</LabelerName>
<SubstanceName>
ATROPINE SULFATE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-07-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240704
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>