<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
48792-7893-1
</NDCCode>
<PackageDescription>
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (48792-7893-1)
</PackageDescription>
<NDC11Code>
48792-7893-01
</NDC11Code>
<ProductNDC>
48792-7893
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Ranolazine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Ranolazine
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20200331
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA211865
</ApplicationNumber>
<LabelerName>
Sunshine Lake Pharma Co., Ltd.
</LabelerName>
<SubstanceName>
RANOLAZINE
</SubstanceName>
<StrengthNumber>
500
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Anti-anginal [EPC],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2021-11-10
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20221231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20200331
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>