"68055-346-10" National Drug Code (NDC)

Baclofen 10 AMPULE in 1 PACKAGE (68055-346-10) > 1 mL in 1 AMPULE
(Sintetica S.A.)

NDC Code68055-346-10
Package Description10 AMPULE in 1 PACKAGE (68055-346-10) > 1 mL in 1 AMPULE
Product NDC68055-346
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBaclofen
Non-Proprietary NameBaclofen
Dosage FormINJECTION
UsageINTRATHECAL
Start Marketing Date20160509
Marketing Category NameANDA
Application NumberANDA091193
ManufacturerSintetica S.A.
Substance NameBACLOFEN
Strength.05
Strength Unitmg/mL
Pharmacy ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]

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