<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71428-009-46
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (71428-009-46) / 460 mL in 1 BOTTLE
</PackageDescription>
<NDC11Code>
71428-0009-46
</NDC11Code>
<ProductNDC>
71428-009
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Rufinamide
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Rufinamide
</NonProprietaryName>
<DosageFormName>
SUSPENSION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20230207
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA214009
</ApplicationNumber>
<LabelerName>
Glasshouse Pharmaceuticals Limited Canada
</LabelerName>
<SubstanceName>
RUFINAMIDE
</SubstanceName>
<StrengthNumber>
40
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2024-01-02
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20231231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20230207
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>