<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63323-180-01
</NDCCode>
<PackageDescription>
25 VIAL in 1 TRAY (63323-180-01) / 1 mL in 1 VIAL (63323-180-00)
</PackageDescription>
<NDC11Code>
63323-0180-01
</NDC11Code>
<ProductNDC>
63323-180
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Pyridoxine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pyridoxine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
19720814
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA080618
</ApplicationNumber>
<LabelerName>
Fresenius Kabi USA, LLC
</LabelerName>
<SubstanceName>
PYRIDOXINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-10-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20000905
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>