<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0116-4010-41
</NDCCode>
<PackageDescription>
100 TRAY in 1 CASE (0116-4010-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4010-10)
</PackageDescription>
<NDC11Code>
00116-4010-41
</NDC11Code>
<ProductNDC>
0116-4010
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Amantadine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Amantadine
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20241105
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA075060
</ApplicationNumber>
<LabelerName>
Xttrium Laboratories, Inc
</LabelerName>
<SubstanceName>
AMANTADINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
50
</StrengthNumber>
<StrengthUnit>
mg/5mL
</StrengthUnit>
<Pharm_Classes>
Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-11-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20251231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20241105
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>