<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68084-915-25
</NDCCode>
<PackageDescription>
30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-915-25) / 1 TABLET in 1 BLISTER PACK (68084-915-95)
</PackageDescription>
<NDC11Code>
68084-0915-25
</NDC11Code>
<ProductNDC>
68084-915
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sirolimus
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sirolimus
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20151105
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA201578
</ApplicationNumber>
<LabelerName>
American Health Packaging
</LabelerName>
<SubstanceName>
SIROLIMUS
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20151105
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>