DEA schedule
Is diclofenac and misoprostol a controlled substance?
Federal schedule for diclofenac and misoprostol from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Diclofenac and misoprostol is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and diclofenac and misoprostol is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 26 prescription listings from 12 labelers, none with a DEA schedule |
| DEA controlled substances list | diclofenac and misoprostol is not on the list |
Diclofenac and Misoprostol NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0025-1411 | ARTHROTEC | tablet, film coated | 50 mg/1; 200 ug/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 0025-1421 | ARTHROTEC | tablet, film coated | 75 mg/1; 200 ug/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 80425-0273 | DICLOENAC SODIUM and MISOPROSTOL DR | tablet | 75 mg/1; 200 ug/1 | Advanced Rx Pharmacy of Tennessee, LLC | None |
| 0591-0397 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 50 mg/1; 200 ug/1 | Actavis Pharma, Inc. | None |
| 42291-232 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 50 mg/1; 200 ug/1 | AvKARE | None |
| 65162-436 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 50 mg/1; 200 ug/1 | Amneal Pharmaceuticals LLC | None |
| 68001-231 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 50 mg/1; 200 ug/1 | BluePoint Laboratories | None |
| 0591-0398 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | Actavis Pharma, Inc. | None |
| 42291-233 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | AvKARE | None |
| 65162-438 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | Amneal Pharmaceuticals LLC | None |
| 68001-232 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | BluePoint Laboratories | None |
| 71335-1183 | Diclofenac Sodium and Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | Bryant Ranch Prepack | None |
| 59762-0028 | Diclofenac sodium and Misoprostol | tablet, film coated | 50 mg/1; 200 ug/1 | Mylan Pharmaceuticals Inc. | None |
| 59762-0029 | Diclofenac sodium and Misoprostol | tablet, film coated | 75 mg/1; 200 ug/1 | Mylan Pharmaceuticals Inc. | None |
| 80425-0272 | Diclofenac sodium and Misoprostol DR | tablet, film coated | 75 mg/1; 200 ug/1 | Advanced Rx Pharmacy of Tennessee, LLC | None |
| 71205-865 | Diclofenac Sodium Misoprostol | tablet, delayed release | 50 mg/1; 200 ug/1 | Proficient Rx LP | None |
| 72162-2518 | Diclofenac Sodium Misoprostol | tablet, delayed release | 50 mg/1; 200 ug/1 | Bryant Ranch Prepack | None |
| 75834-264 | Diclofenac Sodium Misoprostol | tablet, delayed release | 50 mg/1; 200 ug/1 | Nivagen Pharmaceuticals, Inc. | None |
| 71205-866 | Diclofenac Sodium Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | Proficient Rx LP | None |
| 71335-2441 | Diclofenac Sodium Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | Bryant Ranch Prepack | None |
| 72162-2519 | Diclofenac Sodium Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | Bryant Ranch Prepack | None |
| 75834-265 | Diclofenac Sodium Misoprostol | tablet, delayed release | 75 mg/1; 200 ug/1 | Nivagen Pharmaceuticals, Inc. | None |
| 42571-133 | Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL | tablet | 50 mg/1; 200 ug/1 | Micro Labs Limited | None |
| 42571-134 | Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL | tablet | 75 mg/1; 200 ug/1 | Micro Labs Limited | None |
| 71335-2603 | Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL | tablet | 75 mg/1; 200 ug/1 | Bryant Ranch Prepack | None |
| 85766-192 | Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL | tablet | 75 mg/1; 200 ug/1 | Sportpharm LLC | None |
Questions
Is diclofenac and misoprostol a controlled substance?
No. Diclofenac and misoprostol is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and diclofenac and misoprostol is not on the DEA controlled substances list.
Is diclofenac and misoprostol a narcotic?
No. Diclofenac and misoprostol is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Nonsteroidal Anti-inflammatory Drug and Prostaglandin E1 Analog.
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 Diclofenac and Misoprostol
- What is Diclofenac and Misoprostol used for?FDA label uses
- Generic for ArthrotecFDA Orange Book
- Nonsteroidal Anti-inflammatory Drugs listFDA drug class
- Prostaglandin E1 Analogs listFDA drug class
- NDC 0025-1411Diclofenac and Misoprostol NDC record
- NDC 0025-1421Diclofenac and Misoprostol NDC record
- NDC 0591-0397Diclofenac and Misoprostol NDC record