<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63552-191-00
</NDCCode>
<PackageDescription>
208 VIAL in 1 CASE (63552-191-00) / 1.3 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
63552-0191-00
</NDC11Code>
<ProductNDC>
63552-191
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Difelikefalin Acetate
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20210111
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Patheon Manufacturing Services LLC
</LabelerName>
<SubstanceName>
DIFELIKEFALIN ACETATE
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
ug/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2024-11-05
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
11-JAN-21
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>