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NDC 00597-0435-96 Pradaxa 40 mg/1 Details
Pradaxa 40 mg/1
Pradaxa is a ORAL PELLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is DABIGATRAN ETEXILATE MESYLATE.
Product Information
| NDC | 00597-0435 |
|---|---|
| Product ID | 0597-0435_e80e64c0-c622-4e33-86b7-66f8c2ae3722 |
| Associated GPIs | |
| GCN Sequence Number | 082442 |
| GCN Sequence Number Description | dabigatran etexilate mesylate PELET PACK 40 MG ORAL |
| HIC3 | M9T |
| HIC3 Description | THROMBIN INHIBITORS, SELECTIVE, DIRECT, REVERSIBLE |
| GCN | 49867 |
| 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 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | PELLET |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| 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 | NDA214358 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00597-0435-96 (00597043596)
| NDC Package Code | 0597-0435-96 |
|---|---|
| Billing NDC | 00597043596 |
| Package | 1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG |
| Marketing Start Date | 2022-03-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |