NDC 67877-474
Dabigatran Etexilate 75 mg capsule, coated pellets
On the label: Ascend Laboratories, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
Recalls
- Dec 12, 2024 · Class II · Ascend Laboratories, LLC
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Lots: Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026. - Dec 12, 2024 · Class II · Ascend Laboratories, LLC
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Lots: Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026; - Mar 14, 2023 · Class II · Ascend Laboratories, LLC
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Lots: Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024. - Mar 14, 2023 · Class II · Ascend Laboratories, LLC
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Lots: Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Dabigatran: every company that makes it
- Form
- capsule, coated pellets, oral
- Strength
- 75 mg
- Approval
- ANDA ANDA208040
- On the market since
- Jun 20, 2022
- Package NDCs
67877-474-60- Official label
- DailyMed (National Library of Medicine), updated Aug 3, 2026
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