<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0074-3878-10
</NDCCode>
<PackageDescription>
10 VIAL, SINGLE-DOSE in 1 CARTON (0074-3878-10) / 12 mL in 1 VIAL, SINGLE-DOSE (0074-3878-01)
</PackageDescription>
<NDC11Code>
00074-3878-10
</NDC11Code>
<ProductNDC>
0074-3878
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Emblaveo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Aztreonam And Avibactam
</NonProprietaryName>
<DosageFormName>
POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250207
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA217906
</ApplicationNumber>
<LabelerName>
AbbVie Inc.
</LabelerName>
<SubstanceName>
AVIBACTAM; AZTREONAM
</SubstanceName>
<StrengthNumber>
42.3; 127
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Monobactam Antibacterial [EPC], Monobactams [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-05-29
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250207
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>