<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70842-225-01
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (70842-225-01) / 40 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
70842-0225-01
</NDC11Code>
<ProductNDC>
70842-225
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Kimyrsa
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Oritavancin Diphosphate
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20210323
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA214155
</ApplicationNumber>
<LabelerName>
Melinta Therapeutics, LLC
</LabelerName>
<SubstanceName>
ORITAVANCIN DIPHOSPHATE
</SubstanceName>
<StrengthNumber>
1200
</StrengthNumber>
<StrengthUnit>
mg/40mL
</StrengthUnit>
<Pharm_Classes>
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20210323
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>