<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71288-206-02
</NDCCode>
<PackageDescription>
10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01)
</PackageDescription>
<NDC11Code>
71288-0206-02
</NDC11Code>
<ProductNDC>
71288-206
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Alprostadil
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Alprostadil
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION, CONCENTRATE
</DosageFormName>
<RouteName>
INTRAVASCULAR
</RouteName>
<StartMarketingDate>
20240915
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075196
</ApplicationNumber>
<LabelerName>
Meitheal Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
ALPROSTADIL
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
ug/mL
</StrengthUnit>
<Pharm_Classes>
Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-09-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240915
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>