<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
58284-100-14
</NDCCode>
<PackageDescription>
4 POUCH in 1 CARTON (58284-100-14) > 1 IMPLANT in 1 POUCH
</PackageDescription>
<NDC11Code>
58284-0100-14
</NDC11Code>
<ProductNDC>
58284-100
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Probuphine
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Buprenorphine Hydrochloride
</NonProprietaryName>
<DosageFormName>
IMPLANT
</DosageFormName>
<RouteName>
SUBCUTANEOUS
</RouteName>
<StartMarketingDate>
20160609
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
NDA
</MarketingCategoryName>
<ApplicationNumber>
NDA204442
</ApplicationNumber>
<LabelerName>
Braeburn Pharmaceuticals
</LabelerName>
<SubstanceName>
BUPRENORPHINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
80
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes>
Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
</Pharm_Classes>
<DEASchedule>
CIII
</DEASchedule>
<Status>
Deprecated
</Status>
<LastUpdate>
2019-06-13
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20191231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20160609
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>