Medicine
Pradaxa 75 mg capsule
Pradaxa 75 mg capsule is a prescription medicine containing Dabigatran for oral use, marketed by Boehringer Ingelheim Pharmaceuticals, 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 to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Dabigatran
- Brand
- Pradaxa
- Strength
- 75 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle, 60 blister pack
- Marketing authorisation holder
- Boehringer Ingelheim Pharmaceuticals
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- 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). 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
- 8 August 2011
- Identifiers
- RxCUI 1037045, 1037049, 1037179 +3DailyMed set ID ba74e3cd-b06f-4145-b284-5fd6b84ff3c9NDC 0597-0355Application NDA022512
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 60 capsule in 1 bottle | 0597-0355-09 | Boehringer Ingelheim Pharmaceuticals | 28 July 2017 |
| 60 blister pack in 1 carton / 1 capsule in 1 blister pack | 0597-0355-56 | Boehringer Ingelheim Pharmaceuticals | 28 July 2017 |
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 75 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 Pradaxa 75 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.