<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84549-464-01
</NDCCode>
<PackageDescription>
10 mL in 1 VIAL, MULTI-DOSE (84549-464-01)
</PackageDescription>
<NDC11Code>
84549-0464-01
</NDC11Code>
<ProductNDC>
84549-464
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Nalbuphine Hydrochloride
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Nalbuphine Hydrochloride
</NonProprietaryName>
<DosageFormName>
INJECTION, SOLUTION
</DosageFormName>
<RouteName>
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20050719
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA070915
</ApplicationNumber>
<LabelerName>
ProPharma Distribution
</LabelerName>
<SubstanceName>
NALBUPHINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
10
</StrengthNumber>
<StrengthUnit>
mg/mL
</StrengthUnit>
<Pharm_Classes>
Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-20
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250827
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>