<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
16590-002-05
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (16590-002-05) > 5 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
16590-0002-05
</NDC11Code>
<ProductNDC>
16590-002
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Acular
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ketorolac Tromethamine
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
19921201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA019700
</ApplicationNumber>
<LabelerName>
STAT Rx USA LLC
</LabelerName>
<SubstanceName>
KETOROLAC TROMETHAMINE
</SubstanceName>
<StrengthNumber>
5
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2018-02-07
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
E
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20171231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>