<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63323-321-12
</NDCCode>
<PackageDescription>
10 VIAL in 1 TRAY (63323-321-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-321-02)
</PackageDescription>
<NDC11Code>
63323-0321-12
</NDC11Code>
<ProductNDC>
63323-321
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Polymyxin B
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Polymyxin B Sulfate
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
</RouteName>
<StartMarketingDate>
20091117
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA065372
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</LabelerName>
<SubstanceName>
POLYMYXIN B SULFATE
</SubstanceName>
<StrengthNumber>
500000
</StrengthNumber>
<StrengthUnit>
[USP'U]/1
</StrengthUnit>
<Pharm_Classes>
Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2021-06-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20091117
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>