<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0574-4072-05
</NDCCode>
<PackageDescription>
1 BOTTLE, DROPPER in 1 CARTON (0574-4072-05) > 5 mL in 1 BOTTLE, DROPPER
</PackageDescription>
<NDC11Code>
00574-4072-05
</NDC11Code>
<ProductNDC>
0574-4072
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Garamycin Gentamicin Sulfate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Gentamicin Sulfate
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
OPHTHALMIC
</RouteName>
<StartMarketingDate>
20140605
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA065121
</ApplicationNumber>
<LabelerName>
Paddock Laboratories, LLC
</LabelerName>
<SubstanceName>
GENTAMICIN SULFATE
</SubstanceName>
<StrengthNumber>
3
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2017-01-18
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>