<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
66758-252-01
</NDCCode>
<PackageDescription>
100 TABLET in 1 BOTTLE (66758-252-01)
</PackageDescription>
<NDC11Code>
66758-0252-01
</NDC11Code>
<ProductNDC>
66758-252
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Focalin
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Dexmethylphenidate Hydrochloride
</NonProprietaryName>
<DosageFormName>
TABLET
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20011130
</StartMarketingDate>
<EndMarketingDate>
20270930
</EndMarketingDate>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA021278
</ApplicationNumber>
<LabelerName>
Sandoz Inc
</LabelerName>
<SubstanceName>
DEXMETHYLPHENIDATE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
</Pharm_Classes>
<DEASchedule>
CII
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2025-12-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20240712
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20270430
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>