<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
80830-2305-2
</NDCCode>
<PackageDescription>
25 VIAL, SINGLE-DOSE in 1 CARTON (80830-2305-2) / 50 mL in 1 VIAL, SINGLE-DOSE (80830-2305-1)
</PackageDescription>
<NDC11Code>
80830-2305-02
</NDC11Code>
<ProductNDC>
80830-2305
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sodium Bicarbonate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Bicarbonate
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260113
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217523
</ApplicationNumber>
<LabelerName>
Amneal Pharmaceuticals Private Limited
</LabelerName>
<SubstanceName>
SODIUM BICARBONATE
</SubstanceName>
<StrengthNumber>
84
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Alkalinizing Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-22
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260113
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>