DEA schedule
Is dabigatran etexilate a controlled substance?
Federal schedule for dabigatran etexilate from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. 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 | 51 prescription listings from 18 labelers, none with a DEA schedule |
| DEA controlled substances list | dabigatran etexilate is not on the list |
Dabigatran Etexilate 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 |
| 72205-203 | DABIGATRAN | capsule | 110 mg/1 | Novadoz Pharmaceuticals LLC | None |
| 42291-034 | DABIGATRAN | capsule | 150 mg/1 | AvKARE | None |
| 50090-7530 | DABIGATRAN | capsule | 150 mg/1 | A-S Medication Solutions | None |
| 50268-200 | DABIGATRAN | capsule | 150 mg/1 | AvPAK | None |
| 60687-974 | DABIGATRAN | capsule | 150 mg/1 | American Health Packaging | None |
| 72205-204 | DABIGATRAN | capsule | 150 mg/1 | Novadoz Pharmaceuticals LLC | None |
| 42291-033 | DABIGATRAN | capsule | 75 mg/1 | AvKARE | None |
| 50090-7531 | DABIGATRAN | capsule | 75 mg/1 | A-S Medication Solutions | None |
| 60687-963 | DABIGATRAN | capsule | 75 mg/1 | American Health Packaging | None |
| 72205-202 | DABIGATRAN | capsule | 75 mg/1 | Novadoz Pharmaceuticals LLC | None |
| 31722-666 | Dabigatran Etexilate | capsule | 110 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 43598-453 | Dabigatran etexilate | capsule | 110 mg/1 | Dr.Reddys Laboratories Inc | None |
| 46708-635 | Dabigatran Etexilate | capsule | 110 mg/1 | Alembic Pharmaceuticals Limited | None |
| 59651-974 | DABIGATRAN ETEXILATE | capsule | 110 mg/1 | Aurobindo Pharma Limited | None |
| 60505-4349 | dabigatran etexilate | capsule | 110 mg/1 | Apotex Corp. | None |
| 62332-635 | Dabigatran Etexilate | capsule | 110 mg/1 | Alembic Pharmaceuticals Inc. | None |
| 0378-0266 | Dabigatran Etexilate | capsule | 150 mg/1 | Mylan Pharmaceuticals Inc. | None |
| 31722-622 | Dabigatran Etexilate | capsule | 150 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 43598-641 | Dabigatran etexilate | capsule | 150 mg/1 | Dr.Reddys Laboratories Inc | None |
| 46708-636 | Dabigatran Etexilate | capsule | 150 mg/1 | Alembic Pharmaceuticals Limited | None |
| 50090-8158 | Dabigatran Etexilate | capsule | 150 mg/1 | A-S Medication Solutions | None |
| 59651-975 | DABIGATRAN ETEXILATE | capsule | 150 mg/1 | Aurobindo Pharma Limited | None |
| 60505-4348 | dabigatran etexilate | capsule | 150 mg/1 | Apotex Corp. | None |
| 62332-636 | Dabigatran Etexilate | capsule | 150 mg/1 | Alembic Pharmaceuticals Inc. | None |
| 72603-239 | Dabigatran Etexilate | capsule | 150 mg/1 | NorthStar RxLLC | None |
| 72865-273 | Dabigatran Etexilate | capsule | 150 mg/1 | XLCare Pharmaceuticals, Inc. | None |
| 0378-0265 | Dabigatran Etexilate | capsule | 75 mg/1 | Mylan Pharmaceuticals Inc. | None |
| 31722-621 | Dabigatran Etexilate | capsule | 75 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 43598-642 | Dabigatran etexilate | capsule | 75 mg/1 | Dr.Reddys Laboratories Inc | None |
| 46708-634 | Dabigatran Etexilate | capsule | 75 mg/1 | Alembic Pharmaceuticals Limited | None |
| 59651-973 | DABIGATRAN ETEXILATE | capsule | 75 mg/1 | Aurobindo Pharma Limited | None |
Showing 40 of 51 listings.
Questions
Is dabigatran etexilate a controlled substance?
No. 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 dabigatran etexilate a narcotic?
No. 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 Dabigatran Etexilate
- What is Dabigatran Etexilate used for?FDA label uses
- Generic for PradaxaFDA Orange Book
- What is Pradaxa used for?FDA label uses
- Is Pradaxa a controlled substance?Federal schedule
- Direct Thrombin Inhibitors listFDA drug class
- NDC 0597-0108Dabigatran Etexilate NDC record
- NDC 0597-0355Dabigatran Etexilate NDC record
- NDC 0597-0360Dabigatran Etexilate NDC record