<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84312-001-10
</NDCCode>
<PackageDescription>
10 VIAL, SINGLE-DOSE in 1 CARTON (84312-001-10) / 10 mL in 1 VIAL, SINGLE-DOSE (84312-001-01)
</PackageDescription>
<NDC11Code>
84312-0001-10
</NDC11Code>
<ProductNDC>
84312-001
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Zevtera
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ceftobiprole Medocaril Sodium
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA218275
</ApplicationNumber>
<LabelerName>
Basilea Pharmaceutica International AG, Allschwil
</LabelerName>
<SubstanceName>
CEFTOBIPROLE MEDOCARIL SODIUM
</SubstanceName>
<StrengthNumber>
667
</StrengthNumber>
<StrengthUnit>
mg/10mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2025-05-14
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>