"0517-0725-05" National Drug Code (NDC)

Buprenorphine Hydrochloride 5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01)
(American Regent, Inc.)

NDC Code0517-0725-05
Package Description5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01)
Product NDC0517-0725
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Hydrochloride
Non-Proprietary NameBuprenorphine Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAMUSCULAR; INTRAVENOUS
Start Marketing Date20100813
Marketing Category NameANDA
Application NumberANDA078331
ManufacturerAmerican Regent, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Strength.324
Strength Unitmg/mL
Pharmacy ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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