<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
43386-510-87
</NDCCode>
<PackageDescription>
7 BOTTLE, UNIT-DOSE in 1 CARTON (43386-510-87) > 60 mL in 1 BOTTLE, UNIT-DOSE (43386-510-81)
</PackageDescription>
<NDC11Code>
43386-0510-87
</NDC11Code>
<ProductNDC>
43386-510
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Mesalamine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Mesalamine
</NonProprietaryName>
<DosageFormName>
ENEMA
</DosageFormName>
<RouteName>
RECTAL
</RouteName>
<StartMarketingDate>
20091216
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA019618
</ApplicationNumber>
<LabelerName>
GAVIS Pharmaceuticals, LLC
</LabelerName>
<SubstanceName>
MESALAMINE
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
g/60mL
</StrengthUnit>
<Pharm_Classes>
Aminosalicylate [EPC],Aminosalicylic Acids [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-02-13
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
E
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20171231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>