<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68083-398-85
</NDCCode>
<PackageDescription>
1000 BOTTLE, PLASTIC in 1 CASE (68083-398-85) / 2.5 mL in 1 BOTTLE, PLASTIC
</PackageDescription>
<NDC11Code>
68083-0398-85
</NDC11Code>
<ProductNDC>
68083-398
</ProductNDC>
<ProductTypeName>
BULK INGREDIENT
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Olopatadine Hydrochloride Ophthalmic
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20260106
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
EXPORT ONLY
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
Gland Pharma Limited
</LabelerName>
<SubstanceName>
OLOPATADINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
7
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2026-02-06
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
06-JAN-26
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>