DEA schedule
Is Pradaxa a controlled substance?
Pradaxa contains dabigatran etexilate. Federal schedule from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Pradaxa (dabigatran etexilate) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and dabigatran etexilate is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 9 prescription listings from 2 labelers, none with a DEA schedule |
| DEA controlled substances list | dabigatran etexilate is not on the list |
Pradaxa NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0597-0108 | Pradaxa | capsule | 110 mg/1 | Boehringer Ingelheim Pharmaceuticals Inc. | None |
| 0597-0360 | Pradaxa | capsule | 150 mg/1 | Boehringer Ingelheim Pharmaceuticals Inc. | None |
| 0597-0355 | Pradaxa | capsule | 75 mg/1 | Boehringer Ingelheim Pharmaceuticals Inc. | None |
| 0597-0445 | Pradaxa | pellet | 110 mg/1 | Boehringer Ingelheim Pharmaceuticals, Inc. | None |
| 0597-0450 | Pradaxa | pellet | 150 mg/1 | Boehringer Ingelheim Pharmaceuticals, Inc. | None |
| 0597-0425 | Pradaxa | pellet | 20 mg/1 | Boehringer Ingelheim Pharmaceuticals, Inc. | None |
| 0597-0430 | Pradaxa | pellet | 30 mg/1 | Boehringer Ingelheim Pharmaceuticals, Inc. | None |
| 0597-0435 | Pradaxa | pellet | 40 mg/1 | Boehringer Ingelheim Pharmaceuticals, Inc. | None |
| 0597-0440 | Pradaxa | pellet | 50 mg/1 | Boehringer Ingelheim Pharmaceuticals, Inc. | None |
Questions
Is Pradaxa a controlled substance?
No. Pradaxa (dabigatran etexilate) is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and dabigatran etexilate is not on the DEA controlled substances list.
Is Pradaxa a narcotic?
No. Pradaxa (dabigatran etexilate) is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Direct Thrombin Inhibitor.
Does this page cover state schedules?
No. This page reports the federal schedule only. Some states schedule drugs on their own; check your state board of pharmacy.
More on Pradaxa
- What is Pradaxa used for?FDA label uses
- Generic for PradaxaFDA Orange Book
- What is Dabigatran Etexilate used for?FDA label uses
- Is Dabigatran Etexilate a controlled substance?Federal schedule
- Direct Thrombin Inhibitors listFDA drug class
- NDC 0597-0108Pradaxa NDC record
- NDC 0597-0355Pradaxa NDC record
- NDC 0597-0360Pradaxa NDC record