"0378-0266-91" National Drug Code (NDC)

Dabigatran Etexilate 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0266-91)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-0266-91
Package Description60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0266-91)
Product NDC0378-0266
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDabigatran Etexilate
Non-Proprietary NameDabigatran Etexilate
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20250225
Marketing Category NameANDA
Application NumberANDA208067
ManufacturerMylan Pharmaceuticals Inc.
Substance NameDABIGATRAN ETEXILATE MESYLATE
Strength150
Strength Unitmg/1
Pharmacy ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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