<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
16110-245-00
</NDCCode>
<PackageDescription>
48000 TABLET, COATED in 1 BAG (16110-245-00)
</PackageDescription>
<NDC11Code>
16110-0245-00
</NDC11Code>
<ProductNDC>
16110-245
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sarecycline Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20190104
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Almirall, LLC
</LabelerName>
<SubstanceName>
SARECYCLINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
60
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-05-19
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
04-JAN-19
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>