<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68543-2637-9
</NDCCode>
<PackageDescription>
24050 CAPSULE, DELAYED RELEASE PELLETS in 1 DRUM (68543-2637-9)
</PackageDescription>
<NDC11Code>
68543-2637-09
</NDC11Code>
<ProductNDC>
68543-2637
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pancrelipase
</NonProprietaryName>
<DosageFormName>
CAPSULE, DELAYED RELEASE PELLETS
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20240722
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Fournier Laboratories Ireland LTD
</LabelerName>
<SubstanceName>
PANCRELIPASE LIPASE
</SubstanceName>
<StrengthNumber>
36000
</StrengthNumber>
<StrengthUnit>
[USP'U]/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2024-07-27
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
22-JUL-24
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>