<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58458-002-02
</NDCCode>
<PackageDescription>
1 VIAL, GLASS in 1 CARTON (58458-002-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
58458-0002-02
</NDC11Code>
<ProductNDC>
58458-002
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Azacitidine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Azacitidine
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS; SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20250730
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217453
</ApplicationNumber>
<LabelerName>
Reliance Life Sciences Private Limited
</LabelerName>
<SubstanceName>
AZACITIDINE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250730
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>