<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
0054-0843-63
</NDCCode>
<PackageDescription>
473 mL in 1 BOTTLE (0054-0843-63)
</PackageDescription>
<NDC11Code>
00054-0843-63
</NDC11Code>
<ProductNDC>
0054-0843
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Hydrocodone Bitartrate And Acetaminophen
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Hydrocodone Bitartrate And Acetaminophen
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
ORAL
</RouteName>
<StartMarketingDate>
20250602
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA040881
</ApplicationNumber>
<LabelerName>
Hikma Pharmaceuticals USA Inc.
</LabelerName>
<SubstanceName>
ACETAMINOPHEN; HYDROCODONE BITARTRATE
</SubstanceName>
<StrengthNumber>
300; 10
</StrengthNumber>
<StrengthUnit>
mg/15mL; mg/15mL
</StrengthUnit>
<Pharm_Classes>
Opioid Agonist [EPC], Opioid Agonists [MoA]
</Pharm_Classes>
<DEASchedule>
CII
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2025-06-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250616
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>