# Pradaxa

NDC: 0597-0440
Generic name: dabigatran etexilate
Labeler / Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: HUMAN PRESCRIPTION DRUG
Marketing category: New Drug Application (innovator)
Dosage form: PELLET
Routes: ORAL
Marketing started: 20220316

FDA application: NDA214358

## Active ingredients

- DABIGATRAN ETEXILATE MESYLATE: 50 mg/1

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"0597-0440"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=0597-0440
- DailyMed: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9ac0a64a-8666-45f7-9d4f-40fd894f7e6d