<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
66993-475-02
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (66993-475-02) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
</PackageDescription>
<NDC11Code>
66993-0475-02
</NDC11Code>
<ProductNDC>
66993-475
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nisoldipine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nisoldipine
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20120227
</StartMarketingDate>
<EndMarketingDate>
20270531
</EndMarketingDate>
<MarketingCategoryName>
NDA AUTHORIZED GENERIC
</MarketingCategoryName>
<ApplicationNumber>
NDA020356
</ApplicationNumber>
<LabelerName>
Prasco Laboratories
</LabelerName>
<SubstanceName>
NISOLDIPINE
</SubstanceName>
<StrengthNumber>
34
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Calcium Channel Antagonists [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-11-14
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20120227
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20270531
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>