<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
81298-2390-1
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (81298-2390-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
</PackageDescription>
<NDC11Code>
81298-2390-01
</NDC11Code>
<ProductNDC>
81298-2390
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Dalbavancin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dalbavancin Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260303
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218602
</ApplicationNumber>
<LabelerName>
Long Grove Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
DALBAVANCIN HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260303
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>