<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
75834-171-19
</NDCCode>
<PackageDescription>
25 VIAL in 1 CARTON (75834-171-19) > 10 mL in 1 VIAL (75834-171-01)
</PackageDescription>
<NDC11Code>
75834-0171-19
</NDC11Code>
<ProductNDC>
75834-171
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Calcium Gluconate
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Calcium Gluconate
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20221024
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA213071
</ApplicationNumber>
<LabelerName>
Nivagen Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
CALCIUM GLUCONATE MONOHYDRATE
</SubstanceName>
<StrengthNumber>
98
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2026-01-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20221024
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>