<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
45802-453-84
</NDCCode>
<PackageDescription>
1 TUBE in 1 CARTON (45802-453-84) / 45 g in 1 TUBE
</PackageDescription>
<NDC11Code>
45802-0453-84
</NDC11Code>
<ProductNDC>
45802-453
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Adapalene
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Adapalene
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20101026
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA020748
</ApplicationNumber>
<LabelerName>
Padagis Israel Pharmaceuticals Ltd
</LabelerName>
<SubstanceName>
ADAPALENE
</SubstanceName>
<StrengthNumber>
.1
</StrengthNumber>
<StrengthUnit>
g/100g
</StrengthUnit>
<Pharm_Classes>
Retinoid [EPC], Retinoids [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2023-08-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20101027
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>