<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68083-380-01
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CARTON (68083-380-01) > 25 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
68083-0380-01
</NDC11Code>
<ProductNDC>
68083-380
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Allopurinol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Allopurinol
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20220126
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA212363
</ApplicationNumber>
<LabelerName>
Gland Pharma Limited
</LabelerName>
<SubstanceName>
ALLOPURINOL SODIUM
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/25mL
</StrengthUnit>
<Pharm_Classes>
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2022-03-26
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220126
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>