"0597-0108-54" National Drug Code (NDC)

Pradaxa 1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE
(Boehringer Ingelheim Pharmaceuticals Inc.)

NDC Code0597-0108-54
Package Description1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE
Product NDC0597-0108
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePradaxa
Non-Proprietary NameDabigatran Etexilate Mesylate
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20151123
Marketing Category NameNDA
Application NumberNDA022512
ManufacturerBoehringer Ingelheim Pharmaceuticals Inc.
Substance NameDABIGATRAN ETEXILATE MESYLATE
Strength110
Strength Unitmg/1
Pharmacy ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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