<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
67046-1619-3
</NDCCode>
<PackageDescription>
30 CAPSULE in 1 BLISTER PACK (67046-1619-3)
</PackageDescription>
<NDC11Code>
67046-1619-03
</NDC11Code>
<ProductNDC>
67046-1619
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Hydroxyurea
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hydroxyurea
</NonProprietaryName>
<DosageFormName>
CAPSULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20251202
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218021
</ApplicationNumber>
<LabelerName>
Coupler LLC
</LabelerName>
<SubstanceName>
HYDROXYUREA
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Antimetabolite [EPC], Urea [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251202
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>