"0904-7253-04" National Drug Code (NDC)

Dabigatran Etexilate 3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)
(Major Pharmaceuticals)

NDC Code0904-7253-04
Package Description3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)
Product NDC0904-7253
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDabigatran Etexilate
Non-Proprietary NameDabigatran Etexilate
Dosage FormCAPSULE, COATED PELLETS
UsageORAL
Start Marketing Date20250515
Marketing Category NameANDA
Application NumberANDA208040
ManufacturerMajor Pharmaceuticals
Substance NameDABIGATRAN ETEXILATE MESYLATE
Strength75
Strength Unitmg/1
Pharmacy ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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