<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
42023-259-00
</NDCCode>
<PackageDescription>
1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1 CARTON (42023-259-01) / 2.8 mL in 1 VIAL, MULTI-DOSE
</PackageDescription>
<NDC11Code>
42023-0259-00
</NDC11Code>
<ProductNDC>
42023-259
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Leuprolide Acetate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Leuprolide Acetate
</NonProprietaryName>
<DosageFormName>
INJECTION
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20260630
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217437
</ApplicationNumber>
<LabelerName>
Endo USA, Inc.
</LabelerName>
<SubstanceName>
LEUPROLIDE ACETATE
</SubstanceName>
<StrengthNumber>
1
</StrengthNumber>
<StrengthUnit>
mg/.2mL
</StrengthUnit>
<Pharm_Classes>
Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-07-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260630
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>