<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
60687-417-71
</NDCCode>
<PackageDescription>
5 TRAY in 1 CASE (60687-417-71) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-417-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-417-44)
</PackageDescription>
<NDC11Code>
60687-0417-71
</NDC11Code>
<ProductNDC>
60687-417
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Hydrocodone Bitartrate And Acetaminophen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hydrocodone Bitartrate And Acetaminophen
</NonProprietaryName>
<DosageFormName>
SOLUTION
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20190619
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA211023
</ApplicationNumber>
<LabelerName>
American Health Packaging
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; HYDROCODONE BITARTRATE
</SubstanceName>
<StrengthNumber>
325; 7.5
</StrengthNumber>
<StrengthUnit>
mg/15mL; mg/15mL
</StrengthUnit>
<Pharm_Classes>
Opioid Agonist [EPC], Opioid Agonists [MoA]
</Pharm_Classes>
<DEASchedule>
CII
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2025-12-06
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20190619
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>