DEA schedule
Is misoprostol a controlled substance?
Federal schedule for 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. Misoprostol is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and misoprostol is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 25 prescription listings from 16 labelers, none with a DEA schedule |
| DEA controlled substances list | misoprostol is not on the list |
Misoprostol NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0025-1451 | Cytotec | tablet | 100 ug/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 0025-1461 | Cytotec | tablet | 200 ug/1 | Pfizer Laboratories Div Pfizer Inc | None |
| 40032-160 | Misoprostol | tablet | 100 ug/1 | Novel Laboratories, Inc. | None |
| 43386-160 | Misoprostol | tablet | 100 ug/1 | Lupin Pharmaceuticals,Inc. | None |
| 59762-5007 | misoprostol | tablet | 100 ug/1 | Mylan Pharmaceuticals Inc. | None |
| 60687-735 | Misoprostol | tablet | 100 ug/1 | American Health Packaging | None |
| 68071-3762 | Misoprostol | tablet | 100 ug/1 | NuCare Pharmaceuticals, Inc. | None |
| 70954-443 | Misoprostol | tablet | 100 ug/1 | ANI Pharmaceuticals, Inc. | None |
| 71335-2455 | Misoprostol | tablet | 100 ug/1 | Bryant Ranch Prepack | None |
| 71335-9631 | misoprostol | tablet | 100 ug/1 | Bryant Ranch Prepack | None |
| 40032-161 | Misoprostol | tablet | 200 ug/1 | Novel Laboratories, Inc. | None |
| 43386-161 | Misoprostol | tablet | 200 ug/1 | Lupin Pharmaceuticals,Inc. | None |
| 43393-023 | Misoprostol | tablet | 200 ug/1 | GenBioPro, Inc. | None |
| 43393-024 | Misoprostol | tablet | 200 ug/1 | GenBioPro, Inc. | None |
| 43393-200 | Misoprostol | tablet | 200 ug/1 | GenBioPro, Inc. | None |
| 50268-555 | Misoprostol | tablet | 200 ug/1 | AvPAK | None |
| 54348-148 | Misoprostol | tablet | 200 ug/1 | PharmPak, Inc. | None |
| 55154-2145 | Misoprostol | tablet | 200 ug/1 | Cardinal Health 107, LLC | None |
| 59762-5008 | misoprostol | tablet | 200 ug/1 | Mylan Pharmaceuticals Inc. | None |
| 60687-746 | Misoprostol | tablet | 200 ug/1 | American Health Packaging | None |
| 67296-1936 | misoprostol | tablet | 200 ug/1 | Redpharm Drug | None |
| 68071-4843 | Misoprostol | tablet | 200 ug/1 | NuCare Pharmaceuticals,Inc. | None |
| 70954-444 | Misoprostol | tablet | 200 ug/1 | ANI Pharmaceuticals, Inc. | None |
| 72789-300 | Misoprostol | tablet | 200 ug/1 | PD-Rx Pharmaceuticals, Inc. | None |
| 82804-037 | Misoprostol | tablet | 200 ug/1 | Proficient Rx LP | None |
Questions
Is misoprostol a controlled substance?
No. Misoprostol is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and misoprostol is not on the DEA controlled substances list.
Is misoprostol a narcotic?
No. 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 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.