<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70710-2172-1
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CARTON (70710-2172-1) / .05 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
70710-2172-01
</NDC11Code>
<ProductNDC>
70710-2172
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nufymco
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ranibizumab-leyk
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVITREAL
</RouteName>
<StartMarketingDate>
20260611
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
BLA
</MarketingCategoryName>
<ApplicationNumber>
BLA761473
</ApplicationNumber>
<LabelerName>
Zydus Pharmaceuticals USA Inc.
</LabelerName>
<SubstanceName>
RANIBIZUMAB
</SubstanceName>
<StrengthNumber>
.3
</StrengthNumber>
<StrengthUnit>
mg/.05mL
</StrengthUnit>
<Pharm_Classes>
Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-06-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260611
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>