"46708-635-60" National Drug Code (NDC)

Dabigatran Etexilate 60 CAPSULE in 1 BOTTLE (46708-635-60)
(Alembic Pharmaceuticals Limited)

NDC Code46708-635-60
Package Description60 CAPSULE in 1 BOTTLE (46708-635-60)
Product NDC46708-635
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDabigatran Etexilate
Non-Proprietary NameDabigatran Etexilate
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20240813
Marketing Category NameANDA
Application NumberANDA215233
ManufacturerAlembic Pharmaceuticals Limited
Substance NameDABIGATRAN ETEXILATE MESYLATE
Strength110
Strength Unitmg/1
Pharmacy ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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