<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
72690-010-05
</NDCCode>
<PackageDescription>
150 mL in 1 BOTTLE, PLASTIC (72690-010-05)
</PackageDescription>
<NDC11Code>
72690-0010-05
</NDC11Code>
<ProductNDC>
72690-010
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Gloperba
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Colchicine
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20190801
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA210942
</ApplicationNumber>
<LabelerName>
ROMEG Therapeutics, LLC
</LabelerName>
<SubstanceName>
COLCHICINE
</SubstanceName>
<StrengthNumber>
.6
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2021-01-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20201231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20190801
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>