Dabigatran Etexilate is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Dabigatran Etexilate Mesylate.
| Product ID | 67877-474_0e0421ac-0136-46bc-a0c1-d9188c9a4a68 |
| NDC | 67877-474 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dabigatran Etexilate |
| Generic Name | Dabigatran Etexilate |
| Dosage Form | Capsule, Coated Pellets |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-03-13 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208040 |
| Labeler Name | Ascend Laboratories, LLC |
| Substance Name | DABIGATRAN ETEXILATE MESYLATE |
| Active Ingredient Strength | 75 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2022-06-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208040 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-03-13 |
| Marketing End Date | 2020-03-13 |
| Ingredient | Strength |
|---|---|
| DABIGATRAN ETEXILATE MESYLATE | 75 mg/1 |
| SPL SET ID: | 3a8ec82a-c367-40dc-9302-e1896fcb05ea |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 31722-621 | Dabigatran Etexilate | Dabigatran Etexilate |
| 31722-622 | Dabigatran Etexilate | Dabigatran Etexilate |
| 67877-474 | Dabigatran Etexilate | Dabigatran Etexilate |
| 67877-475 | Dabigatran Etexilate | Dabigatran Etexilate |
| 0597-0425 | Pradaxa | dabigatran etexilate |
| 0597-0430 | Pradaxa | dabigatran etexilate |
| 0597-0435 | Pradaxa | dabigatran etexilate |
| 0597-0440 | Pradaxa | dabigatran etexilate |
| 0597-0445 | Pradaxa | dabigatran etexilate |
| 0597-0450 | Pradaxa | dabigatran etexilate |