<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0078-0937-91
</NDCCode>
<PackageDescription>
4 TABLET in 1 BLISTER PACK (0078-0937-91)
</PackageDescription>
<NDC11Code>
00078-0937-91
</NDC11Code>
<ProductNDC>
0078-0937
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Egaten
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Triclabendazole
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20190213
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA208711
</ApplicationNumber>
<LabelerName>
Novartis Pharmaceuticals Corporation
</LabelerName>
<SubstanceName>
TRICLABENDAZOLE
</SubstanceName>
<StrengthNumber>
250
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Anthelmintic [EPC], Anthelmintics [CS], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2A6 Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-03-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20190213
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>