"0115-1011-01" National Drug Code (NDC)

Baclofen 100 TABLET in 1 BOTTLE (0115-1011-01)
(Amneal Pharmaceuticals of New York LLC)

NDC Code0115-1011-01
Package Description100 TABLET in 1 BOTTLE (0115-1011-01)
Product NDC0115-1011
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBaclofen
Non-Proprietary NameBaclofen
Dosage FormTABLET
UsageORAL
Start Marketing Date20210601
Marketing Category NameANDA
Application NumberANDA077971
ManufacturerAmneal Pharmaceuticals of New York LLC
Substance NameBACLOFEN
Strength5
Strength Unitmg/1
Pharmacy ClassesGABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]

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