Refludan - 50419-150-57 - (lepirudin)

Alphabetical Index


Drug Information of Refludan

Product NDC: 50419-150
Proprietary Name: Refludan
Non Proprietary Name: lepirudin
Active Ingredient(s): 50    mg/mL & nbsp;   lepirudin
Administration Route(s): INTRAVENOUS
Dosage Form(s): POWDER
Coding System: National Drug Codes(NDC)

Labeler Information of Refludan

Product NDC: 50419-150
Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020807
Marketing Category: NDA
Start Marketing Date: 20070309

Package Information of Refludan

Package NDC: 50419-150-57
Package Description: 10 VIAL in 1 BOX (50419-150-57) > 1 mL in 1 VIAL

NDC Information of Refludan

NDC Code 50419-150-57
Proprietary Name Refludan
Package Description 10 VIAL in 1 BOX (50419-150-57) > 1 mL in 1 VIAL
Product NDC 50419-150
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name lepirudin
Dosage Form Name POWDER
Route Name INTRAVENOUS
Start Marketing Date 20070309
Marketing Category Name NDA
Labeler Name Bayer HealthCare Pharmaceuticals Inc.
Substance Name LEPIRUDIN
Strength Number 50
Strength Unit mg/mL
Pharmaceutical Classes Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]

Complete Information of Refludan


General Information