<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0121-2106-02
</NDCCode>
<PackageDescription>
1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01)
</PackageDescription>
<NDC11Code>
00121-2106-02
</NDC11Code>
<ProductNDC>
0121-2106
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Leuprolide Acetate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Leuprolide Acetate
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20250201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217957
</ApplicationNumber>
<LabelerName>
PAI Holdings, LLC dba PAI Pharma
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-02-04
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>