"59385-016-30" National Drug Code (NDC)

Bunavail 30 POUCH in 1 BOX (59385-016-30) > 1 FILM in 1 POUCH (59385-016-01)
(BioDelivery Sciences International, Inc.)

NDC Code59385-016-30
Package Description30 POUCH in 1 BOX (59385-016-30) > 1 FILM in 1 POUCH (59385-016-01)
Product NDC59385-016
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBunavail
Non-Proprietary NameBuprenorphine And Naloxone
Dosage FormFILM
UsageBUCCAL
Start Marketing Date20140930
End Marketing Date20210731
Marketing Category NameNDA
Application NumberNDA205637
ManufacturerBioDelivery Sciences International, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Strength6.3; 1
Strength Unitmg/1; mg/1
Pharmacy ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII

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