<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71357-009-10
</NDCCode>
<PackageDescription>
10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (71357-009-10) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (71357-009-01)
</PackageDescription>
<NDC11Code>
71357-0009-10
</NDC11Code>
<ProductNDC>
71357-009
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sodium Acetate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Acetate Injection, Usp, 400 Meq/100 Ml
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION, CONCENTRATE
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20241206
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214805
</ApplicationNumber>
<LabelerName>
MILLA PHARMACEUTICALS INC.
</LabelerName>
<SubstanceName>
SODIUM ACETATE
</SubstanceName>
<StrengthNumber>
400
</StrengthNumber>
<StrengthUnit>
meq/100mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-12-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241206
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>