<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
49349-013-02
</NDCCode>
<PackageDescription>
30 TABLET, SUGAR COATED in 1 BLISTER PACK (49349-013-02)
</PackageDescription>
<NDC11Code>
49349-0013-02
</NDC11Code>
<ProductNDC>
49349-013
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Rifater
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Rifampin, Isoniazid, Pyrazinamide
</NonProprietaryName>
<DosageFormName>
TABLET, SUGAR COATED
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20100915
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA050705
</ApplicationNumber>
<LabelerName>
REMEDYREPACK INC.
</LabelerName>
<SubstanceName>
RIFAMPIN; ISONIAZID; PYRAZINAMIDE
</SubstanceName>
<StrengthNumber>
120; 50; 300
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Rifamycin Antibacterial [EPC],Rifamycins [Chemical/Ingredient],Antimycobacterial [EPC],Antimycobacterial [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2016-12-02
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>