<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
54348-148-09
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BOX (54348-148-09) > 9 TABLET in 1 BOTTLE
</PackageDescription>
<NDC11Code>
54348-0148-09
</NDC11Code>
<ProductNDC>
54348-148
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Misoprostol
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Misoprostol
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20190710
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA091667
</ApplicationNumber>
<LabelerName>
PharmPak, Inc.
</LabelerName>
<SubstanceName>
MISOPROSTOL
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
ug/1
</StrengthUnit>
<Pharm_Classes>
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2022-10-12
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20190710
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>