<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82804-175-28
</NDCCode>
<PackageDescription>
1 BLISTER PACK in 1 BAG (82804-175-28) / 28 TABLET in 1 BLISTER PACK
</PackageDescription>
<NDC11Code>
82804-0175-28
</NDC11Code>
<ProductNDC>
82804-175
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Norethindrone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Norethindrone
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20201111
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA091325
</ApplicationNumber>
<LabelerName>
Proficient Rx LP
</LabelerName>
<SubstanceName>
NORETHINDRONE
</SubstanceName>
<StrengthNumber>
.35
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Progesterone Congeners [CS], Progestin [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20201111
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>