<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63187-777-05
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (63187-777-05) > 5 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
63187-0777-05
</NDC11Code>
<ProductNDC>
63187-777
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ketorolac Tromethamine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ketorolac Tromethamine
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20091207
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA076109
</ApplicationNumber>
<LabelerName>
Proficient Rx LP
</LabelerName>
<SubstanceName>
KETOROLAC TROMETHAMINE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2022-11-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20161101
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>