Quick answers
- What is Dabigatran etexilate used for?
- The FDA-approved label (Pradaxa, Boehringer Ingelheim Pharmaceuticals, Inc., June 27, 2025) says: “PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated 1.1 Treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dabigatran etexilate have a boxed warning?
- Yes. The FDA label for Pradaxa has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Dabigatran etexilate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dabigatran etexilate been recalled?
- FDA enforcement reports list 9 recalls of products of this medicine; the newest started July 16, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Dabigatran etexilate?
- 17 companies list prescription products of Dabigatran etexilate in the FDA NDC Directory, including Boehringer Ingelheim Pharmaceuticals, Inc., A-S Medication Solutions and Novadoz Pharmaceuticals LLC.
What Dabigatran etexilate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated 1.1 Treatment of …
— FDA label: Pradaxa, Boehringer Ingelheim Pharmaceuticals, Inc., effective June 27, 2025. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
20 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Capsule, coated pellets · Pellet |
|---|---|
| Route | Oral |
| Prescription products | 51 in the FDA NDC Directory |
| Brand names | Pradaxa |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dabigatran etexilate mesylate 110 mg capsule | Generic | $0.8961 per capsule |
| dabigatran etexilate mesylate 110 mg capsule | Brand: Pradaxa | $3.17 per capsule |
| dabigatran etexilate mesylate 110 mg capsule, coated pellets | Generic | $0.8961 per capsule |
| dabigatran etexilate mesylate 150 mg capsule | Generic | $0.8005 per capsule |
| dabigatran etexilate mesylate 150 mg capsule | Brand: Pradaxa | $3.16 per capsule |
| dabigatran etexilate mesylate 150 mg capsule, coated pellets | Generic | $0.8005 per capsule |
| dabigatran etexilate mesylate 75 mg capsule | Generic | $0.7152 per capsule |
| dabigatran etexilate mesylate 75 mg capsule | Brand: Pradaxa | $3.17 per capsule |
| dabigatran etexilate mesylate 75 mg capsule, coated pellets | Generic | $0.7152 per capsule |
NADAC list of November 4, 2026; these prices took effect between July 22, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Boehringer Ingelheim Pharmaceuticals, Inc.9 products
- A-S Medication Solutions5 products
- Novadoz Pharmaceuticals LLC3 products
- Major Pharmaceuticals3 products
- Alembic Pharmaceuticals Inc.3 products
- Alembic Pharmaceuticals Limited3 products
- Ascend Laboratories, LLC3 products
- Camber Pharmaceuticals, Inc.3 products
- Dr.Reddys Laboratories Inc3 products
- Apotex Corp.3 products
- Aurobindo Pharma Limited3 products
- XLCare Pharmaceuticals, Inc.2 products
- American Health Packaging2 products
- AvKARE2 products
- Mylan Pharmaceuticals Inc.2 products
- AvPAK1 product
- NorthStar RxLLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022512 PRADAXA | Boehringer Ingelheim | October 19, 2010 | 31, latest June 17, 2025 2025: Labeling · 2023: Labeling · 2021: Efficacy |
| NDA214358 PRADAXA | Boehringer Ingelheim | June 21, 2021 | 4, latest June 17, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (8)
- ANDA208040Alkem Labs Ltd · March 11, 2020
- ANDA207961Hetero Labs Ltd III · May 6, 2020
- ANDA208070Apotex · December 15, 2023
- ANDA213879Msn · May 22, 2024
- ANDA215233Alembic · June 14, 2024
- ANDA208048DR Reddys · January 28, 2025
- ANDA208067Mylan · February 3, 2025
- ANDA208039Aurobindo Pharma · May 14, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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July 16, 2026 · Class III · Ongoing · D-0737-2026
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
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN — Ascend Laboratories, LLC
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July 16, 2026 · Class III · Ongoing · D-0738-2026
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
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46 — Ascend Laboratories, LLC
-
July 16, 2026 · Class III · Ongoing · D-0739-2026
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
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 4 — Ascend Laboratories, LLC
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June 30, 2026 · Class III · Ongoing · D-0735-2026
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.
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68. — Ascend Laboratories, LLC
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June 30, 2026 · Class III · Ongoing · D-0736-2026
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.
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10. — Ascend Laboratories, LLC
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December 12, 2024 · Class II · Ongoing · D-0129-2025
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60 — Ascend Laboratories, LLC
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December 12, 2024 · Class II · Ongoing · D-0130-2025
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60 — Ascend Laboratories, LLC
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March 14, 2023 · Class II · Ongoing · D-0533-2023
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60. — Ascend Laboratories, LLC
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March 14, 2023 · Class II · Ongoing · D-0534-2023
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60. — Ascend Laboratories, LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pradaxa, Boehringer Ingelheim Pharmaceuticals, Inc., effective June 27, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →