<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
65145-202-25
</NDCCode>
<PackageDescription>
25 VIAL, SINGLE-DOSE in 1 CARTON (65145-202-25) / 50 mL in 1 VIAL, SINGLE-DOSE (65145-202-01)
</PackageDescription>
<NDC11Code>
65145-0202-25
</NDC11Code>
<ProductNDC>
65145-202
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sodium Phosphates
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Sodium Phosphates
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20260310
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA220683
</ApplicationNumber>
<LabelerName>
Caplin Steriles Limited
</LabelerName>
<SubstanceName>
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
</SubstanceName>
<StrengthNumber>
268; 276
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-03-11
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260310
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>