<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68001-565-28
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (68001-565-28) / 10 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
68001-0565-28
</NDC11Code>
<ProductNDC>
68001-565
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cyclophosphamide
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cyclophosphamide
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20230410
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA212501
</ApplicationNumber>
<LabelerName>
BluePoint Laboratories
</LabelerName>
<SubstanceName>
CYCLOPHOSPHAMIDE ANHYDROUS
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-08-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20230410
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>