<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
55488-0544-2
</NDCCode>
<PackageDescription>
500 TABLET in 1 BOTTLE (55488-0544-2)
</PackageDescription>
<NDC11Code>
55488-0544-02
</NDC11Code>
<ProductNDC>
55488-0544
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ticagrelor
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ticagrelor
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251028
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA216187
</ApplicationNumber>
<LabelerName>
Changzhou Pharmaceutical Factory
</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>
2025-11-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251028
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>