"0406-8005-03" National Drug Code (NDC)

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate 30 TABLET in 1 BOTTLE, PLASTIC (0406-8005-03)
(SpecGx LLC)

NDC Code0406-8005-03
Package Description30 TABLET in 1 BOTTLE, PLASTIC (0406-8005-03)
Product NDC0406-8005
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Non-Proprietary NameBuprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20171213
Marketing Category NameANDA
Application NumberANDA207000
ManufacturerSpecGx LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Strength2; .5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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