<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
33342-431-12
</NDCCode>
<PackageDescription>
10 BLISTER PACK in 1 CARTON (33342-431-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
33342-0431-12
</NDC11Code>
<ProductNDC>
33342-431
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ticagrelor
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ticagrelor
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251028
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212258
</ApplicationNumber>
<LabelerName>
Macleods Pharmaceuticals Limited
</LabelerName>
<SubstanceName>
TICAGRELOR
</SubstanceName>
<StrengthNumber>
60
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-29
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251028
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>