<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
60505-6124-1
</NDCCode>
<PackageDescription>
10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6124-1) / 20 mL in 1 VIAL, SINGLE-DOSE (60505-6124-0)
</PackageDescription>
<NDC11Code>
60505-6124-01
</NDC11Code>
<ProductNDC>
60505-6124
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ceftaroline Fosamil
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ceftaroline Fosamil
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260212
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA208075
</ApplicationNumber>
<LabelerName>
Apotex Corp.
</LabelerName>
<SubstanceName>
CEFTAROLINE FOSAMIL
</SubstanceName>
<StrengthNumber>
400
</StrengthNumber>
<StrengthUnit>
mg/20mL
</StrengthUnit>
<Pharm_Classes>
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260212
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>