"0054-0177-13" National Drug Code (NDC)

Buprenorphine Hcl 30 TABLET in 1 BOTTLE (0054-0177-13)
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0177-13
Package Description30 TABLET in 1 BOTTLE (0054-0177-13)
Product NDC0054-0177
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Hcl
Non-Proprietary NameBuprenorphine Hcl
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20091008
Marketing Category NameANDA
Application NumberANDA078633
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Strength8
Strength Unitmg/1
Pharmacy ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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