Pradaxa - 0597-0135-54 - (dabigatran etexilate mesylate)

Alphabetical Index


Drug Information of Pradaxa

Product NDC: 0597-0135
Proprietary Name: Pradaxa
Non Proprietary Name: dabigatran etexilate mesylate
Active Ingredient(s): 150    mg/1 & nbsp;   dabigatran etexilate mesylate
Administration Route(s): ORAL
Dosage Form(s): CAPSULE
Coding System: National Drug Codes(NDC)

Labeler Information of Pradaxa

Product NDC: 0597-0135
Labeler Name: Boehringer Ingelheim Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022512
Marketing Category: NDA
Start Marketing Date: 20101026

Package Information of Pradaxa

Package NDC: 0597-0135-54
Package Description: 1 BOTTLE in 1 CARTON (0597-0135-54) > 60 CAPSULE in 1 BOTTLE

NDC Information of Pradaxa

NDC Code 0597-0135-54
Proprietary Name Pradaxa
Package Description 1 BOTTLE in 1 CARTON (0597-0135-54) > 60 CAPSULE in 1 BOTTLE
Product NDC 0597-0135
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name dabigatran etexilate mesylate
Dosage Form Name CAPSULE
Route Name ORAL
Start Marketing Date 20101026
Marketing Category Name NDA
Labeler Name Boehringer Ingelheim Pharmaceuticals Inc.
Substance Name DABIGATRAN ETEXILATE MESYLATE
Strength Number 150
Strength Unit mg/1
Pharmaceutical Classes

Complete Information of Pradaxa


General Information