<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65219-292-77
</NDCCode>
<PackageDescription>
1 TRAY in 1 CARTON (65219-292-77) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (65219-290-02) * 1 mL in 1 SYRINGE (65219-286-01)
</PackageDescription>
<NDC11Code>
65219-0292-77
</NDC11Code>
<ProductNDC>
65219-292
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cetrorelix Acetate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Cetrorelix Acetate
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20240731
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA218150
</ApplicationNumber>
<LabelerName>
FRESENIUS KABI USA, LLC
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-07-31
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240731
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>