NDC 0904-7253
Dabigatran Etexilate 75 mg capsule, coated pellets
On the label: Major Pharmaceuticals.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it, tests it and packages it | No problems foundAug 30, 2019 · 6 inspections |
Recalls
- Jul 16, 2026 · Class III · Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots: Lot: 25141583, Exp. April 30, 2027. - Jul 16, 2026 · Class III · Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots: Lot: 25141585, Exp. April 30, 2027. - Jul 16, 2026 · Class III · Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots: Lot: 25141586, Exp. April 30, 2027. - Jun 30, 2026 · Class III · Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Lots: Lot: 25141707, Exp 4/30/2027. - Jun 30, 2026 · Class III · Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Lots: Lot: 25141584, Exp 4/30/2027.
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 23, 2025
- Package NDCs
0904-7253-040904-7253-350904-7253-68- Official label
- DailyMed (National Library of Medicine), updated Jun 12, 2025
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