DEA schedule
Is lubiprostone a controlled substance?
Federal schedule for lubiprostone from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Lubiprostone is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and lubiprostone is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 43 prescription listings from 19 labelers, none with a DEA schedule |
| DEA controlled substances list | lubiprostone is not on the list |
Lubiprostone NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 23635-524 | Amitiza | capsule, gelatin coated | 24 ug/1 | SpecGx LLC | None |
| 64764-240 | Amitiza | capsule, gelatin coated | 24 ug/1 | Takeda Pharmaceuticals America, Inc. | None |
| 23635-508 | Amitiza | capsule, gelatin coated | 8 ug/1 | SpecGx LLC | None |
| 64764-080 | Amitiza | capsule, gelatin coated | 8 ug/1 | Takeda Pharmaceuticals America, Inc. | None |
| 72189-410 | Amitza | capsule, gelatin coated | 8 ug/1 | Direct_Rx | None |
| 31722-403 | Lubiprostone | capsule | .008 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 72603-288 | Lubiprostone | capsule | .008 mg/1 | Northstar Rx LLC | None |
| 31722-404 | Lubiprostone | capsule | .024 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 72603-289 | Lubiprostone | capsule | .024 mg/1 | Northstar Rx LLC | None |
| 65162-842 | Lubiprostone | capsule | 24 ug/1 | Amneal Pharmaceuticals LLC | None |
| 70710-1642 | Lubiprostone | capsule | 24 ug/1 | Zydus Pharmaceuticals USA Inc. | None |
| 70771-1764 | Lubiprostone | capsule | 24 ug/1 | Zydus Lifesciences Limited | None |
| 76420-778 | Lubiprostone | capsule | 24 ug/1 | Asclemed USA, Inc. | None |
| 65162-841 | Lubiprostone | capsule | 8 ug/1 | Amneal Pharmaceuticals LLC | None |
| 70710-1641 | Lubiprostone | capsule | 8 ug/1 | Zydus Pharmaceuticals USA Inc. | None |
| 70771-1763 | Lubiprostone | capsule | 8 ug/1 | Zydus Lifesciences Limited | None |
| 76420-777 | Lubiprostone | capsule | 8 ug/1 | Asclemed USA, Inc. | None |
| 0254-3029 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Par Health USA, LLC | None |
| 0406-6424 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | SpecGx LLC | None |
| 0480-4138 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Teva Pharmaceuticals, Inc. | None |
| 43598-168 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Dr. Reddy's Laboratories Inc. | None |
| 51407-745 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Golden State Medical Supply, Inc. | None |
| 60687-827 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | American Health Packaging | None |
| 63304-352 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Sun Pharmaceutical Industries, Inc. | None |
| 69339-163 | LUBIPROSTONE | capsule, gelatin coated | 24 ug/1 | Natco Pharma USA LLC | None |
| 71205-832 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Proficient Rx LP | None |
| 71205-834 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Proficient Rx LP | None |
| 72189-607 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Direct Rx | None |
| 76420-907 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Asclemed USA, Inc. | None |
| 80425-0355 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Advanced Rx of Tennessee, LLC | None |
| 82804-001 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Proficient Rx LP | None |
| 82804-304 | Lubiprostone | capsule, gelatin coated | 24 ug/1 | Proficient Rx LP | None |
| 0254-3028 | Lubiprostone | capsule, gelatin coated | 8 ug/1 | Par Health USA, LLC | None |
| 0406-6408 | Lubiprostone | capsule, gelatin coated | 8 ug/1 | SpecGx LLC | None |
| 0480-3479 | Lubiprostone | capsule, gelatin coated | 8 ug/1 | Teva Pharmaceuticals, Inc. | None |
| 43598-163 | Lubiprostone | capsule, gelatin coated | 8 ug/1 | Dr. Reddy's Laboratories Inc. | None |
| 51407-744 | Lubiprostone | capsule, gelatin coated | 8 ug/1 | Golden State Medical Supply, Inc. | None |
| 60687-816 | Lubiprostone | capsule, gelatin coated | 8 ug/1 | American Health Packaging | None |
| 63304-351 | Lubiprostone | capsule, gelatin coated | 8 ug/1 | Sun Pharmaceutical Industries, Inc. | None |
| 69339-162 | LUBIPROSTONE | capsule, gelatin coated | 8 ug/1 | Natco Pharma USA LLC | None |
Showing 40 of 43 listings.
Questions
Is lubiprostone a controlled substance?
No. Lubiprostone is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and lubiprostone is not on the DEA controlled substances list.
Is lubiprostone a narcotic?
No. Lubiprostone is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Chloride Channel Activator.
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.