<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71288-035-52
</NDCCode>
<PackageDescription>
12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51)
</PackageDescription>
<NDC11Code>
71288-0035-52
</NDC11Code>
<ProductNDC>
71288-035
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Contepo
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fosfomycin Disodium
</NonProprietaryName>
<DosageFormName>
INJECTION, POWDER, FOR SOLUTION
</DosageFormName>
<RouteName>
INTRAVENOUS
</RouteName>
<StartMarketingDate>
20251022
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA212271
</ApplicationNumber>
<LabelerName>
Meitheal Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
FOSFOMYCIN SODIUM
</SubstanceName>
<StrengthNumber>
6
</StrengthNumber>
<StrengthUnit>
g/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251022
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>