<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82576-080-30
</NDCCode>
<PackageDescription>
30 TABLET, COATED in 1 BOTTLE (82576-080-30)
</PackageDescription>
<NDC11Code>
82576-0080-30
</NDC11Code>
<ProductNDC>
82576-080
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Rezdiffra
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Resmetirom
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20240314
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA217785
</ApplicationNumber>
<LabelerName>
Madrigal Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
RESMETIROM
</SubstanceName>
<StrengthNumber>
80
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], Thyroid Hormone Receptor beta Agonist [EPC], Thyroid Hormone Receptor beta Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240314
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>