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