<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
52544-064-31
</NDCCode>
<PackageDescription>
3 BLISTER PACK in 1 CARTON (52544-064-31) / 1 KIT in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
52544-0064-31
</NDC11Code>
<ProductNDC>
52544-064
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Layolis Fe
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Norethindrone, Ethinyl Estradiol, And Ferrous Fumarate
</NonProprietaryName>
<DosageFormName>
KIT
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20111223
</StartMarketingDate>
<EndMarketingDate>
20260331
</EndMarketingDate>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA022573
</ApplicationNumber>
<LabelerName>
Actavis Pharma, Inc.
</LabelerName>
<SubstanceName/>
<StrengthNumber/>
<StrengthUnit/>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20111223
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20260331
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>