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NDC 00597-0355-53 Pradaxa 75 mg/1 Details
Pradaxa 75 mg/1
Pradaxa is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals Inc.. The primary component is DABIGATRAN ETEXILATE MESYLATE.
MedlinePlus Drug Summary
Dabigatran is used to treat deep vein thrombosis (DVT; a blood clot, usually in the leg) and pulmonary embolism (PE; a blood clot in the lung) in adults and children 3 months of age and older who have been treated with an injectable anticoagulant ('blood thinner'). It is also used to reduce the risk of a DVT and PE from happening again after initial treatment is completed in adults and children 3 months of age and older. Dabigatran is used to help prevent DVT and PE in adults who have had hip replacement surgery. Dabigatran is also used to help prevent strokes or serious blood clots in adults who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant medications called direct thrombin inhibitors. It works by preventing blood clots from forming in the body.
Related Packages: 00597-0355-53Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dabigatran
Product Information
| NDC | 00597-0355 |
|---|---|
| Product ID | 0597-0355_00778be6-a0f3-4092-9023-4c4bdcdb7286 |
| Associated GPIs | 83337030200120 |
| GCN Sequence Number | 063997 |
| GCN Sequence Number Description | dabigatran etexilate mesylate CAPSULE 75 MG ORAL |
| HIC3 | M9T |
| HIC3 Description | THROMBIN INHIBITORS, SELECTIVE, DIRECT, REVERSIBLE |
| GCN | 99708 |
| HICL Sequence Number | 035604 |
| HICL Sequence Number Description | DABIGATRAN ETEXILATE MESYLATE |
| Brand/Generic | Brand |
| Proprietary Name | Pradaxa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dabigatran etexilate mesylate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 75 |
| Active Ingredient Units | mg/1 |
| Substance Name | DABIGATRAN ETEXILATE MESYLATE |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals Inc. |
| Pharmaceutical Class | Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022512 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00597-0355-53 (00597035553)
| NDC Package Code | 0597-0355-53 |
|---|---|
| Billing NDC | 00597035553 |
| Package | 12 BLISTER PACK in 1 CARTON (0597-0355-53) / 1 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2017-07-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |