<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80830-2468-2
</NDCCode>
<PackageDescription>
10 BOTTLE, PLASTIC in 1 CARTON (80830-2468-2) / 100 mL in 1 BOTTLE, PLASTIC (80830-2468-1)
</PackageDescription>
<NDC11Code>
80830-2468-02
</NDC11Code>
<ProductNDC>
80830-2468
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Iohexol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Iohexol
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRA-ARTICULAR; INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL
</RouteName>
<StartMarketingDate>
20251113
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217737
</ApplicationNumber>
<LabelerName>
Amneal Pharmaceuticals Private Limited
</LabelerName>
<SubstanceName>
IOHEXOL
</SubstanceName>
<StrengthNumber>
300
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-27
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251113
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>