Tracleer - 66215-102-06 - (bosentan)

Alphabetical Index


Drug Information of Tracleer

Product NDC: 66215-102
Proprietary Name: Tracleer
Non Proprietary Name: bosentan
Active Ingredient(s): 125    mg/1 & nbsp;   bosentan
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Tracleer

Product NDC: 66215-102
Labeler Name: Actelion Pharmaceuticals US, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021290
Marketing Category: NDA
Start Marketing Date: 20011120

Package Information of Tracleer

Package NDC: 66215-102-06
Package Description: 1 BOTTLE, PLASTIC in 1 CARTON (66215-102-06) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Information of Tracleer

NDC Code 66215-102-06
Proprietary Name Tracleer
Package Description 1 BOTTLE, PLASTIC in 1 CARTON (66215-102-06) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product NDC 66215-102
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name bosentan
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20011120
Marketing Category Name NDA
Labeler Name Actelion Pharmaceuticals US, Inc.
Substance Name BOSENTAN
Strength Number 125
Strength Unit mg/1
Pharmaceutical Classes Endothelin Receptor Antagonist [EPC],Endothelin Receptor Antagonists [MoA]

Complete Information of Tracleer


General Information