<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68788-0633-5
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (68788-0633-5) > 5 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
68788-0633-05
</NDC11Code>
<ProductNDC>
68788-0633
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Gentamicin Sulfate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Gentamicin Sulfate
</NonProprietaryName>
<DosageFormName>
SOLUTION/ DROPS
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20130314
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA064048
</ApplicationNumber>
<LabelerName>
Preferred Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
GENTAMICIN SULFATE
</SubstanceName>
<StrengthNumber>
3
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2020-06-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20201231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20130314
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>