PillDabigatran Etexilate
Dabigatran Etexilate Mesylate
3 active makers
soon
soon
soon
soon
US acquisition costNADAC · per unit
Average across 8 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it3 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Major Pharmaceuticals | unknown | 5 | SUPPLYING |
| Ascend Laboratories, LLC | unknown | 4 | SUPPLYING |
| A-S Medication Solutions | unknown | 2 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Dec 12, 2024RECALLRecall (Class II): Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distr…
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit — Recalling firm: Ascend Laboratories, LLC — Nationwide within the United States
- Dec 12, 2024RECALLRecall (Class II): Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distr…
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit — Recalling firm: Ascend Laboratories, LLC — Nationwide within the United States
- Mar 14, 2023RECALLRecall (Class II): Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd.…
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. — Recalling firm: Ascend Laboratories, LLC — Nationwide in the USA.
- Mar 14, 2023RECALLRecall (Class II): Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA,…
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. — Recalling firm: Ascend Laboratories, LLC — Nationwide in the USA.