<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70069-048-20
</NDCCode>
<PackageDescription>
20 VIAL, GLASS in 1 CARTON (70069-048-20) / 100 mL in 1 VIAL, GLASS
</PackageDescription>
<NDC11Code>
70069-0048-20
</NDC11Code>
<ProductNDC>
70069-048
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sodium Acetate Anhydrous
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Acetate Anhydrous
</NonProprietaryName>
<DosageFormName>
SOLUTION, CONCENTRATE
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20251023
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA219826
</ApplicationNumber>
<LabelerName>
Somerset Therapeutics, LLC
</LabelerName>
<SubstanceName>
SODIUM ACETATE ANHYDROUS
</SubstanceName>
<StrengthNumber>
164
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-10-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251023
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>