"58284-216-01" National Drug Code (NDC)

Brixadi 1 SYRINGE, GLASS in 1 CARTON (58284-216-01) / .32 mL in 1 SYRINGE, GLASS
(Braeburn Inc.)

NDC Code58284-216-01
Package Description1 SYRINGE, GLASS in 1 CARTON (58284-216-01) / .32 mL in 1 SYRINGE, GLASS
Product NDC58284-216
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBrixadi
Non-Proprietary NameBuprenorphine
Dosage FormINJECTION
UsageSUBCUTANEOUS
Start Marketing Date20230606
Marketing Category NameNDA
Application NumberNDA210136
ManufacturerBraeburn Inc.
Substance NameBUPRENORPHINE
Strength16
Strength Unitmg/.32mL
Pharmacy ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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