<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
76483-108-02
</NDCCode>
<PackageDescription>
10 VIAL in 1 BOX (76483-108-02) / 10 mL in 1 VIAL (76483-108-01)
</PackageDescription>
<NDC11Code>
76483-0108-02
</NDC11Code>
<ProductNDC>
76483-108
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Calcium Chloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Calcium Chloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260115
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217463
</ApplicationNumber>
<LabelerName>
SQUARE PHARMACEUTICALS PLC.
</LabelerName>
<SubstanceName>
CALCIUM CHLORIDE
</SubstanceName>
<StrengthNumber>
100
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260115
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>