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Pradaxa
Pradaxa - 0597-0107-54 - (dabigatran etexilate mesylate)
Drug Information of Pradaxa
| Product NDC: | 0597-0107 |
| Proprietary Name: | Pradaxa |
| Non Proprietary Name: | dabigatran etexilate mesylate |
| Active Ingredient(s): | 75 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: | 0597-0107 |
| Labeler Name: | Boehringer Ingelheim Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022512 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20101108 |
Package Information of Pradaxa
| Package NDC: | 0597-0107-54 |
| Package Description: | 1 BOTTLE in 1 CARTON (0597-0107-54) > 60 CAPSULE in 1 BOTTLE |
NDC Information of Pradaxa
| NDC Code | 0597-0107-54 |
| Proprietary Name | Pradaxa |
| Package Description | 1 BOTTLE in 1 CARTON (0597-0107-54) > 60 CAPSULE in 1 BOTTLE |
| Product NDC | 0597-0107 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | dabigatran etexilate mesylate |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20101108 |
| Marketing Category Name | NDA |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals Inc. |
| Substance Name | DABIGATRAN ETEXILATE MESYLATE |
| Strength Number | 75 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |
