"70518-4571-0" National Drug Code (NDC)

Buprenorphine Hydrochloride 30 POUCH in 1 BOX (70518-4571-0) / 1 TABLET in 1 POUCH (70518-4571-1)
(REMEDYREPACK INC.)

NDC Code70518-4571-0
Package Description30 POUCH in 1 BOX (70518-4571-0) / 1 TABLET in 1 POUCH (70518-4571-1)
Product NDC70518-4571
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBuprenorphine Hydrochloride
Non-Proprietary NameBuprenorphine Hydrochloride
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20260210
Marketing Category NameANDA
Application NumberANDA090622
ManufacturerREMEDYREPACK INC.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Strength8
Strength Unitmg/1
Pharmacy ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII

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