<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
33342-461-82
</NDCCode>
<PackageDescription>
1 BLISTER PACK in 1 CARTON (33342-461-82) / 252 CAPSULE in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
33342-0461-82
</NDC11Code>
<ProductNDC>
33342-461
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pirfenidone Capsule, 267 Mg
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pirfenidone Capsule, 267 Mg
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20200720
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212748
</ApplicationNumber>
<LabelerName>
Macleods Pharmaceuticals Limited
</LabelerName>
<SubstanceName>
PIRFENIDONE
</SubstanceName>
<StrengthNumber>
267
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Pyridone [EPC], Pyridones [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-04-08
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200720
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>