<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68083-567-25
</NDCCode>
<PackageDescription>
25 VIAL in 1 CARTON (68083-567-25) / 2 mL in 1 VIAL
</PackageDescription>
<NDC11Code>
68083-0567-25
</NDC11Code>
<ProductNDC>
68083-567
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Thiamine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Thiamine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS
</RouteName>
<StartMarketingDate>
20250224
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217800
</ApplicationNumber>
<LabelerName>
Gland Pharma Limited
</LabelerName>
<SubstanceName>
THIAMINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
200
</StrengthNumber>
<StrengthUnit>
mg/2mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-02-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250224
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>