<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70095-136-03
</NDCCode>
<PackageDescription>
1 CARTON in 1 CARTON (70095-136-03) / 21 BLISTER PACK in 1 CARTON (70095-136-02) / 1 INSERT in 1 BLISTER PACK (70095-136-01)
</PackageDescription>
<NDC11Code>
70095-0136-03
</NDC11Code>
<ProductNDC>
70095-136
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Progesterone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Progesterone
</NonProprietaryName>
<DosageFormName>
INSERT
</DosageFormName>
<RouteName>
VAGINAL
</RouteName>
<StartMarketingDate>
20260427
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA022057
</ApplicationNumber>
<LabelerName>
Sun Pharmaceutical Industries, Inc.
</LabelerName>
<SubstanceName>
PROGESTERONE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Progesterone [CS], Progesterone [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-04-30
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260427
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>