<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
76126-054-05
</NDCCode>
<PackageDescription>
1 VIAL in 1 CARTON (76126-054-05) > 5 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
76126-0054-05
</NDC11Code>
<ProductNDC>
76126-054
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Zoledronic Acid
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zoledronic Acid
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION, CONCENTRATE
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20130305
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA202650
</ApplicationNumber>
<LabelerName>
AGILA SPECIALTIES PRIVATE LIMITED
</LabelerName>
<SubstanceName>
ZOLEDRONIC ACID
</SubstanceName>
<StrengthNumber>
4
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Bisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2014-06-23
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>