<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
31722-480-30
</NDCCode>
<PackageDescription>
30 POUCH in 1 CARTON (31722-480-30) / 1 FILM, SOLUBLE in 1 POUCH (31722-480-31)
</PackageDescription>
<NDC11Code>
31722-0480-30
</NDC11Code>
<ProductNDC>
31722-480
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Buprenorphine And Naloxone
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Buprenorphine And Naloxone
</NonProprietaryName>
<DosageFormName>
FILM, SOLUBLE
</DosageFormName>
<RouteName>
BUCCAL; SUBLINGUAL
</RouteName>
<StartMarketingDate>
20260501
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
ANDA
</MarketingCategoryName>
<ApplicationNumber>
ANDA219850
</ApplicationNumber>
<LabelerName>
Camber Pharmaceuticals, Inc.
</LabelerName>
<SubstanceName>
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
4; 1
</StrengthNumber>
<StrengthUnit>
mg/1; mg/1
</StrengthUnit>
<Pharm_Classes>
Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Active
</Status>
<LastUpdate>
2026-05-01
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260501
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>