<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
62332-635-06
</NDCCode>
<PackageDescription>
10 BLISTER PACK in 1 CARTON (62332-635-06) / 6 CAPSULE in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
62332-0635-06
</NDC11Code>
<ProductNDC>
62332-635
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dabigatran Etexilate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dabigatran Etexilate
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20240813
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA215233
</ApplicationNumber>
<LabelerName>
Alembic Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
DABIGATRAN ETEXILATE MESYLATE
</SubstanceName>
<StrengthNumber>
110
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240813
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>