The short version
Just 3 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Dabigatran Etexilate
Dabigatran Etexilate · DABIGATRAN ETEXILATE MESYLATE 110 mg/1 · Capsule, Coated Pellets · Oral · Ascend Laboratories, LLC
NDC 67877-0624-31 · 10 BLISTER PACK in 1 CARTON / 6 CAPSULE, COATED PELLETS in 1 BLISTER PACK · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for dabigatran etexilate (oral solid) in the next 90 days
sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Regulatory
- Application
- ANDA208040
- TE code
- AB
- Approval date
- Mar 11, 2020
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · OngoingDec 12, 2024Ascend Laboratories, LLC — CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- Class II · OngoingDec 12, 2024Ascend Laboratories, LLC — CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- Class II · OngoingMar 14, 2023Ascend Laboratories, LLC — CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
- Class II · OngoingMar 14, 2023Ascend Laboratories, LLC — CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Manufacturers of Dabigatran Etexilate (Capsule, Coated Pellets)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| A-S Medication Solutions | DABIGATRAN ETEXILATE MESYLATE 75 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| A-S Medication Solutions | DABIGATRAN ETEXILATE MESYLATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | DABIGATRAN ETEXILATE MESYLATE 75 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | DABIGATRAN ETEXILATE MESYLATE 110 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Ascend Laboratories, LLC | DABIGATRAN ETEXILATE MESYLATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | DABIGATRAN ETEXILATE MESYLATE 75 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | DABIGATRAN ETEXILATE MESYLATE 110 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Major Pharmaceuticals | DABIGATRAN ETEXILATE MESYLATE 150 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Dabigatran Etexilate — NDC 67877-0624-31," retrieved September 3, 2026, https://drugdashboards.com/drug/67877062431.
Free to cite with attribution — see how the data is put together.