"0054-0188-13" National Drug Code (NDC)

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate 30 TABLET in 1 BOTTLE (0054-0188-13)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0188-13
Package Description30 TABLET in 1 BOTTLE (0054-0188-13)
Product NDC0054-0188
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 Date20140627
Marketing Category NameANDA
Application NumberANDA203326
ManufacturerHikma Pharmaceuticals USA Inc.
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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