"0597-0435-96" National Drug Code (NDC)

Pradaxa 1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG
(Boehringer Ingelheim Pharmaceuticals, Inc.)

NDC Code0597-0435-96
Package Description1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG
Product NDC0597-0435
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NamePradaxa
Non-Proprietary NameDabigatran Etexilate
Dosage FormPELLET
UsageORAL
Start Marketing Date20220316
Marketing Category NameNDA
Application NumberNDA214358
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameDABIGATRAN ETEXILATE MESYLATE
Strength40
Strength Unitmg/1
Pharmacy ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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