<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
64566-0016-1
</NDCCode>
<PackageDescription>
1 BAG in 1 BOX (64566-0016-1) / 18000 CAPSULE in 1 BAG
</PackageDescription>
<NDC11Code>
64566-0016-01
</NDC11Code>
<ProductNDC>
64566-0016
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Isotretinoin
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20240901
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Catalent France Beinheim SA
</LabelerName>
<SubstanceName>
ISOTRETINOIN
</SubstanceName>
<StrengthNumber>
30
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2024-09-03
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
01-SEP-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>