<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
87706-866-01
</NDCCode>
<PackageDescription>
1 VIAL, SINGLE-DOSE in 1 CARTON (87706-866-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (87706-866-00)
</PackageDescription>
<NDC11Code>
87706-0866-01
</NDC11Code>
<ProductNDC>
87706-866
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Zaynich
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zidebactam Dihydrate And Cefepime Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260529
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA220787
</ApplicationNumber>
<LabelerName>
Wockhardt Suisse USA LLC
</LabelerName>
<SubstanceName>
CEFEPIME HYDROCHLORIDE; ZIDEBACTAM DIHYDRATE
</SubstanceName>
<StrengthNumber>
2; 1
</StrengthNumber>
<StrengthUnit>
g/1; g/1
</StrengthUnit>
<Pharm_Classes>
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-06-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260529
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>