<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50742-359-21
</NDCCode>
<PackageDescription>
1 CARTON in 1 CARTON (50742-359-21) / 21 BLISTER PACK in 1 CARTON (50742-359-07) / 1 INSERT in 1 BLISTER PACK (50742-359-03)
</PackageDescription>
<NDC11Code>
50742-0359-21
</NDC11Code>
<ProductNDC>
50742-359
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Progesterone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Progesterone
</NonProprietaryName>
<DosageFormName>
INSERT
</DosageFormName>
<RouteName>
VAGINAL
</RouteName>
<StartMarketingDate>
20261016
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA219588
</ApplicationNumber>
<LabelerName>
Ingenus Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
PROGESTERONE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Progesterone [CS], Progesterone [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-10-23
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20261016
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>