<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
69238-1595-2
</NDCCode>
<PackageDescription>
1 BOTTLE, PLASTIC in 1 CARTON (69238-1595-2) / 225 mL in 1 BOTTLE, PLASTIC
</PackageDescription>
<NDC11Code>
69238-1595-02
</NDC11Code>
<ProductNDC>
69238-1595
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Mycophenolate Mofetil
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Mycophenolate Mofetil
</NonProprietaryName>
<DosageFormName>
POWDER, FOR SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20211105
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214871
</ApplicationNumber>
<LabelerName>
Amneal Pharmaceuticals NY LLC
</LabelerName>
<SubstanceName>
MYCOPHENOLATE MOFETIL
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Antimetabolite Immunosuppressant [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-22
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20211105
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>