Data / Drug companies / Dabigatran etexilate
Dabigatran etexilate: 17 companies and 48 products in the FDA NDC directory
Dabigatran etexilate is listed in the FDA National Drug Code Directory by 17 companies, with 48 products in commercial distribution. 42 of the products (87.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; capsule, coated pellets; pellet, and the newest product started marketing on July 14, 2026.
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- Companies listing it
- 17
- Products
- 48
- Generic (ANDA) products
- 42 (87.5%)
- Application numbers
- 9
- Routes
- Oral
- Brand names
- Dabigatran, Pradaxa
- openFDA record search
- api.fda.gov
Companies that list dabigatran etexilate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | 6 | pellet | New drug applications (NDA) | March 16, 2022 |
| A-S Medication Solutions | 5 | capsule; capsule, coated pellets | Generic drugs (ANDA) | May 22, 2024 |
| Alembic Pharmaceuticals Inc. | 3 | capsule | Generic drugs (ANDA) | August 13, 2024 |
| Alembic Pharmaceuticals Limited | 3 | capsule | Generic drugs (ANDA) | August 13, 2024 |
| Apotex Corp. | 3 | capsule | Generic drugs (ANDA) | February 13, 2024 |
| Ascend Laboratories, LLC | 3 | capsule, coated pellets | Generic drugs (ANDA) | September 12, 2025 |
| Aurobindo Pharma Limited | 3 | capsule | Generic drugs (ANDA) | May 14, 2025 |
| Camber Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | August 13, 2024 |
| Dr. Reddy's Laboratories Inc. | 3 | capsule | Generic drugs (ANDA) | February 28, 2025 |
| Major Pharmaceuticals | 3 | capsule, coated pellets | Generic drugs (ANDA) | June 23, 2025 |
| Novadoz Pharmaceuticals LLC | 3 | capsule | Generic drugs (ANDA) | August 12, 2024 |
| American Health Packaging | 2 | capsule | Generic drugs (ANDA) | July 14, 2026 |
| AvKARE | 2 | capsule | Generic drugs (ANDA) | November 27, 2024 |
| Mylan Pharmaceuticals Inc. | 2 | capsule | Generic drugs (ANDA) | February 25, 2025 |
| XLCare Pharmaceuticals, Inc. | 2 | capsule | Generic drugs (ANDA) | August 1, 2023 |
| AvPAK | 1 | capsule | Generic drugs (ANDA) | July 12, 2025 |
| NorthStar RxLLC | 1 | capsule | Generic drugs (ANDA) | December 1, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 34 | 70.8% |
| Capsule, coated pellets | 8 | 16.7% |
| Pellet | 6 | 12.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 42 | 87.5% |
| New drug applications (NDA) | 6 | 12.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Direct Thrombin Inhibitor | 48 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.