Medicine
Dabigatran 150 mg capsule
Dabigatran 150 mg capsule is a generic prescription medicine for oral use, made by 15 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Dabigatran
- Brand
- Sold under the generic name
- Strength
- 150 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 10 blister pack, 180 capsules, 60 capsules and 23 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaNovadoz PharmaceuticalsIndiaAscend LaboratoriesIndiaDr. Reddy's LaboratoriesIndiaA-S Medication SolutionsMajor PharmaceuticalsAmerican Health PackagingApotex
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 15°C to 30°C (59°F to 86°F). Blisters Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original package to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B01AE07 Dabigatran
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 May 2020
- Identifiers
- RxCUI 1037045, 1037179, 1723476DailyMed set ID dd47a015-ff90-d7a7-8dcb-4e6e31a68071, 834a3c5f-b723-4bcb-a560-dc305dd0d829, d5937f27-88c7-4c4a-801e-4c8945008982 +15NDC 60505-4348, 62332-636, 72603-239 +15Application ANDA208070, ANDA215233, ANDA207961 +5
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 10 blister pack in 1 carton / 6 capsule in 1 blister pack | 46708-636-06 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 180 capsule in 1 bottle | 46708-636-45 | Alembic PharmaceuticalsIndia | 8 October 2025 |
| 60 capsule in 1 bottle | 46708-636-60 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 10 blister pack in 1 carton / 6 capsule in 1 blister pack | 62332-636-06 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 180 capsule in 1 bottle | 62332-636-45 | Alembic PharmaceuticalsIndia | 8 October 2025 |
| 60 capsule in 1 bottle | 62332-636-60 | Alembic PharmaceuticalsIndia | 14 June 2024 |
| 60 capsule, coated pellets in 1 bottle | 67877-475-60 | Ascend LaboratoriesIndia | 20 June 2022 |
| 60 capsule in 1 bottle | 59651-975-60 | Aurobindo PharmaIndia | 14 May 2025 |
| 10 blister pack in 1 carton / 6 capsule in 1 blister pack | 59651-975-61 | Aurobindo PharmaIndia | 14 May 2025 |
| 10 blister pack in 1 carton / 6 capsule in 1 blister pack | 31722-622-32 | Camber PharmaceuticalsIndia | 3 February 2025 |
| 60 capsule in 1 bottle | 31722-622-60 | Camber PharmaceuticalsIndia | 6 May 2020 |
| 60 capsule in 1 bottle | 43598-641-60 | Dr. Reddy's LaboratoriesIndia | 28 February 2025 |
| 6 blister pack in 1 carton / 10 capsule in 1 blister pack | 72205-204-34 | Novadoz PharmaceuticalsIndia | 1 October 2024 |
| 60 capsule in 1 bottle | 72205-204-60 | Novadoz PharmaceuticalsIndia | 24 May 2024 |
| 60 capsule in 1 bottle | 60505-4348-6 | Apotex | 13 February 2024 |
| 60 capsule in 1 bottle, plastic | 0378-0266-91 | Mylan Pharmaceuticals | 25 February 2025 |
| 60 capsule in 1 bottle | 72865-273-60 | XLCare Pharmaceuticals | 1 August 2023 |
| 60 capsule in 1 bottle | 50090-7530-0 | A-S Medication Solutions | 7 April 2025 |
| 60 capsule, coated pellets in 1 bottle | 50090-7657-0 | A-S Medication Solutions | 18 September 2025 |
| 60 capsule in 1 bottle | 50090-8158-0 | A-S Medication Solutions | 16 October 2026 |
| 20 blister pack in 1 carton / 1 capsule in 1 blister pack | 60687-974-32 | American Health Packaging | 25 June 2026 |
| 60 capsule in 1 bottle | 42291-034-60 | AvKARE | 27 November 2024 |
| 60 blister pack in 1 box / 1 capsule in 1 blister pack | 50268-200-16 | AvPAK | 12 July 2025 |
| 2 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack | 0904-7255-10 | Major Pharmaceuticals | 23 June 2025 |
| 6 blister pack in 1 carton / 10 capsule, coated pellets in 1 blister pack | 0904-7255-68 | Major Pharmaceuticals | 23 June 2025 |
| 60 capsule in 1 bottle | 72603-239-01 | NorthStar RxLLC | 1 December 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Dabigatran 150 mg capsule.
Other strengths and forms of Dabigatran
Clinical summary
Dabigatran is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, among other approved uses. It is available as capsules and oral pellets. MedsAcross supplies Dabigatran for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DabigatranFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Pradaxa prescribing information (Boehringer Ingelheim Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Pradaxa: European public assessment report (EPAR) · European Medicines Agency
- Dabigatran Etexilate Accord: European public assessment report (EPAR) · European Medicines Agency
Need Dabigatran 150 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.