<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68094-064-20
</NDCCode>
<PackageDescription>
1 PACKET in 1 CARTON (68094-064-20) / 1 GRANULE in 1 PACKET (68094-064-01)
</PackageDescription>
<NDC11Code>
68094-0064-20
</NDC11Code>
<ProductNDC>
68094-064
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Fosfomycin Tromethamine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Fosfomycin Tromethamine
</NonProprietaryName>
<DosageFormName>
GRANULE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20260215
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA217187
</ApplicationNumber>
<LabelerName>
Precision Dose, Inc.
</LabelerName>
<SubstanceName>
FOSFOMYCIN TROMETHAMINE
</SubstanceName>
<StrengthNumber>
3
</StrengthNumber>
<StrengthUnit>
g/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260215
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>