<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70010-028-22
</NDCCode>
<PackageDescription>
60000 TABLET in 1 DRUM (70010-028-22)
</PackageDescription>
<NDC11Code>
70010-0028-22
</NDC11Code>
<ProductNDC>
70010-028
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ramelteon
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20201001
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Granules Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
RAMELTEON
</SubstanceName>
<StrengthNumber>
8
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-03-12
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
01-OCT-20
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>