<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
49502-378-15
</NDCCode>
<PackageDescription>
1 BOTTLE, GLASS in 1 CARTON (49502-378-15) / 150 mL in 1 BOTTLE, GLASS
</PackageDescription>
<NDC11Code>
49502-0378-15
</NDC11Code>
<ProductNDC>
49502-378
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ermeza
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Levothyroxine Sodium
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20221214
</StartMarketingDate>
<EndMarketingDate>
20260731
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA215809
</ApplicationNumber>
<LabelerName>
Viatris Specialty LLC
</LabelerName>
<SubstanceName>
LEVOTHYROXINE SODIUM
</SubstanceName>
<StrengthNumber>
30
</StrengthNumber>
<StrengthUnit>
ug/mL
</StrengthUnit>
<Pharm_Classes>
Thyroxine [CS], l-Thyroxine [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20221214
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20260731
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>