<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0006-5083-01
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (0006-5083-01) / 4.8 mL in 1 VIAL (0006-5083-99)
</PackageDescription>
<NDC11Code>
00006-5083-01
</NDC11Code>
<ProductNDC>
0006-5083
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Keytruda Qlex
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pembrolizumab And Berahyaluronidase Alfa-pmph
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20250919
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761467
</ApplicationNumber>
<LabelerName>
Merck Sharp & Dohme LLC
</LabelerName>
<SubstanceName>
BERAHYALURONIDASE ALFA; PEMBROLIZUMAB
</SubstanceName>
<StrengthNumber>
2000; 165
</StrengthNumber>
<StrengthUnit>
U/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-05
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250919
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>