"85534-0004-0" National Drug Code (NDC)

Baclofen 100 TABLET in 1 BOTTLE (85534-0004-0)
(HAWAII REPACK, INC.)

NDC Code85534-0004-0
Package Description100 TABLET in 1 BOTTLE (85534-0004-0)
Product NDC85534-0004
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBaclofen
Non-Proprietary NameBaclofen
Dosage FormTABLET
UsageORAL
Start Marketing Date20210713
Marketing Category NameANDA
Application NumberANDA214099
ManufacturerHAWAII REPACK, INC.
Substance NameBACLOFEN
Strength20
Strength Unitmg/1
Pharmacy ClassesGABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]

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