"46708-634-06" National Drug Code (NDC)

Dabigatran Etexilate 10 BLISTER PACK in 1 CARTON (46708-634-06) / 6 CAPSULE in 1 BLISTER PACK
(Alembic Pharmaceuticals Limited)

NDC Code46708-634-06
Package Description10 BLISTER PACK in 1 CARTON (46708-634-06) / 6 CAPSULE in 1 BLISTER PACK
Product NDC46708-634
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDabigatran Etexilate
Non-Proprietary NameDabigatran Etexilate
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20240614
Marketing Category NameANDA
Application NumberANDA215233
ManufacturerAlembic Pharmaceuticals Limited
Substance NameDABIGATRAN ETEXILATE MESYLATE
Strength75
Strength Unitmg/1
Pharmacy ClassesDirect Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]

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