<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0781-3487-14
</NDCCode>
<PackageDescription>
5 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-14) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3487-70)
</PackageDescription>
<NDC11Code>
00781-3487-14
</NDC11Code>
<ProductNDC>
0781-3487
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Iron Sucrose
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Iron Sucrose
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
INTRAVITREAL
</RouteName>
<StartMarketingDate>
20250922
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212340
</ApplicationNumber>
<LabelerName>
Sandoz Inc
</LabelerName>
<SubstanceName>
IRON SUCROSE
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/10mL
</StrengthUnit>
<Pharm_Classes>
Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-09-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250922
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>