Dabigatran Etexilate 150 mg/1
Dabigatran Etexilate · CAPSULE · NorthStar RxLLC
Dabigatran Etexilate is a capsule containing dabigatran etexilate at 150 mg/1, taken oral. Manufactured by NorthStar RxLLC.
Key Facts
- Brand Name
- Dabigatran Etexilate
- Generic Name
- Dabigatran Etexilate
- NDC Code (Product)
72603-239- Manufacturer
- NorthStar RxLLC
- Strength
- 150 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207961
- Marketing Start
- 12/01/2025
Recall History
Boehringer Ingelheim Roxane Inc
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Ascend Laboratories, LLC
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Ascend Laboratories, LLC
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Ascend Laboratories, LLC
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Ascend Laboratories, LLC
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: • To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) • To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) • For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) • For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5 ) • To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. 1.2 Tre…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Non-valvular Atrial Fibrillation in Adult Patients: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily ( 2.2 ) o For patients with CrCl 15 to 30 mL/min: 75 mg orally, twice daily ( 2.2 ) • Treatment of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5 to 10 days of parenteral anticoagulation ( 2.2 ) • Reduction in the Risk of Recurrence of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment ( 2.2 ) • Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients : o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily ( 2.2 ) • Treatment of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.3 ) • Reduction in the Risk of Recurrence of Pediatric VTE: o For pediatric patients: weight-based dosage, twice daily after previous treatment ( 2.3 ) • Dabigatran etexilate capsules are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms • Review recommendations for co…
Contraindications
4 CONTRAINDICATIONS Dabigatran etexilate capsules are contraindicated in patients with: • Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] • History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)] • Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)] • Active pathological bleeding ( 4 ) • History of serious hypersensitivity reaction to dabigatran etexilate capsules ( 4 ) • Mechanical prosthetic heart valve ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • P-gp inducers: Avoid coadministration with dabigatran etexilate capsules ( 5.5 ) • P-gp inhibitors in adult patients with CrCl 30 to 50 mL/min: Reduce dosage or avoid ( 7 ) • P-gp inhibitors in adult patients with CrCl <30 mL/min: Not recommended ( 7 ) 7.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients The concomitant use of dabigatran etexilate with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided [see Clinical Pharmacology (12.3)] . P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran [see Clinical Pharmacology (12.3)] . Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone. In patients with moderate renal impairment (CrCl 30 to 50 mL/min), reduce the dosage of dabigatran etexilate to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromy…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1)] Risk of Bleeding [see Warnings and Precautions (5.2)] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3)] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4)] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6)] The most serious adverse reactions reported with dabigatran etexilate were related to bleeding [see Warnings and Precautions (5.2)]. Most common adverse reactions (>15%) are gastrointestinal adverse reactions and bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in …
Frequently Asked Questions
What is Dabigatran Etexilate used for?
Dabigatran Etexilate contains Dabigatran Etexilate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Dabigatran Etexilate a controlled substance?
Dabigatran Etexilate is not classified as a controlled substance by the DEA.
What is the generic name for Dabigatran Etexilate?
The generic name for Dabigatran Etexilate is Dabigatran Etexilate. There are 8 other brand versions of Dabigatran Etexilate.
What is the NDC code for Dabigatran Etexilate 150 mg/1?
The NDC (National Drug Code) for Dabigatran Etexilate 150 mg/1 is 72603-239, listed by NorthStar RxLLC.