"68055-416-01" National Drug Code (NDC)

Baclofen 1 AMPULE in 1 PACKAGE (68055-416-01) > 20 mL in 1 AMPULE
(Sintetica S.A.)

NDC Code68055-416-01
Package Description1 AMPULE in 1 PACKAGE (68055-416-01) > 20 mL in 1 AMPULE
Product NDC68055-416
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
Strength40
Strength Unitmg/20mL
Pharmacy ClassesGABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]

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