<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0722-7184-01
</NDCCode>
<PackageDescription>
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0722-7184-01)
</PackageDescription>
<NDC11Code>
00722-7184-01
</NDC11Code>
<ProductNDC>
0722-7184
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Codeine And Chlorpheniramine Maleate Er
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Codeine And Chlorpheniramine Maleate Er
</NonProprietaryName>
<DosageFormName>
TABLET, EXTENDED RELEASE
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20150901
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA206323
</ApplicationNumber>
<LabelerName>
Nexgen Pharma, Inc.
</LabelerName>
<SubstanceName>
CODEINE PHOSPHATE; CHLORPHENIRAMINE MALEATE
</SubstanceName>
<StrengthNumber>
54.3; 8
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-09-21
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag>
E
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20181231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage/>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>