<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70518-3731-2
</NDCCode>
<PackageDescription>
100 POUCH in 1 BOX (70518-3731-2) / 1 CAPSULE in 1 POUCH (70518-3731-1)
</PackageDescription>
<NDC11Code>
70518-3731-02
</NDC11Code>
<ProductNDC>
70518-3731
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Mycobutin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Rifabutin
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20230514
</StartMarketingDate>
<EndMarketingDate>
20241023
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA050689
</ApplicationNumber>
<LabelerName>
REMEDYREPACK INC.
</LabelerName>
<SubstanceName>
RIFABUTIN
</SubstanceName>
<StrengthNumber>
150
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2024-10-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20231021
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20241023
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>