<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
63629-4399-2
</NDCCode>
<PackageDescription>
20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4399-2)
</PackageDescription>
<NDC11Code>
63629-4399-02
</NDC11Code>
<ProductNDC>
63629-4399
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Cetirizine Hcl And Pseudoephedrine Hcl
</ProprietaryName>
<ProprietaryNameSuffix>
Er
</ProprietaryNameSuffix>
<NonProprietaryName>
Cetirizine Hcl And Pseudoephedrine Hcl
</NonProprietaryName>
<DosageFormName>
TABLET, FILM COATED, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20080305
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA077991
</ApplicationNumber>
<LabelerName>
Bryant Ranch Prepack
</LabelerName>
<SubstanceName>
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
5; 120
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Deprecated
</Status>
<LastUpdate>
2018-11-28
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20080305
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>