<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
66220-637-31
</NDCCode>
<PackageDescription>
168 h in 1 POUCH (66220-637-31)
</PackageDescription>
<NDC11Code>
66220-0637-31
</NDC11Code>
<ProductNDC>
66220-637
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Sancuso
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Granisetron
</NonProprietaryName>
<DosageFormName>
PATCH
</DosageFormName>
<RouteName>
TRANSDERMAL
</RouteName>
<StartMarketingDate>
20240716
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA022198
</ApplicationNumber>
<LabelerName>
Cumberland Pharmaceuticals Inc.
</LabelerName>
<SubstanceName>
GRANISETRON
</SubstanceName>
<StrengthNumber>
3.1
</StrengthNumber>
<StrengthUnit>
mg/24h
</StrengthUnit>
<Pharm_Classes>
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-11-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240716
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>