"58284-100-14" National Drug Code (NDC)

Probuphine 4 POUCH in 1 CARTON (58284-100-14) > 1 IMPLANT in 1 POUCH
(Braeburn Pharmaceuticals)

NDC Code58284-100-14
Package Description4 POUCH in 1 CARTON (58284-100-14) > 1 IMPLANT in 1 POUCH
Product NDC58284-100
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameProbuphine
Non-Proprietary NameBuprenorphine Hydrochloride
Dosage FormIMPLANT
UsageSUBCUTANEOUS
Start Marketing Date20160609
Marketing Category NameNDA
Application NumberNDA204442
ManufacturerBraeburn Pharmaceuticals
Substance NameBUPRENORPHINE HYDROCHLORIDE
Strength80
Strength Unitmg/1
Pharmacy ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII

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