DEA schedule
Is ursodiol a controlled substance?
Federal schedule for ursodiol from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Ursodiol is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and ursodiol 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 28 labelers, none with a DEA schedule |
| DEA controlled substances list | ursodiol is not on the list |
Ursodiol NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 58914-785 | Urso 250 | tablet, film coated | 250 mg/1 | Allergan, Inc. | None |
| 58914-790 | Urso Forte | tablet, film coated | 500 mg/1 | Allergan, Inc. | None |
| 80056-143 | Reltone 200 mg | capsule | 200 mg/1 | Intra-Sana Laboratories | None |
| 80056-144 | Reltone 400 mg | capsule | 400 mg/1 | Intra-Sana Laboratories | None |
| 0527-1326 | Ursodiol | capsule | 300 mg/1 | Lannett Company, Inc. | None |
| 0591-3159 | Ursodiol | capsule | 300 mg/1 | Actavis Pharma, Inc. | None |
| 0904-6221 | Ursodiol | capsule | 300 mg/1 | Major Pharmaceuticals | None |
| 24658-780 | Ursodiol | capsule | 300 mg/1 | PuraCap Laboratories, LLC | None |
| 24658-999 | Ursodiol | capsule | 300 mg/1 | PuraCap Laboratories, LLC | None |
| 42291-923 | Ursodiol | capsule | 300 mg/1 | AvKARE | None |
| 42385-946 | Ursodiol | capsule | 300 mg/1 | Laurus Labs Limited | None |
| 42806-503 | Ursodiol | capsule | 300 mg/1 | Epic Pharma, LLC | None |
| 50268-797 | Ursodiol | capsule | 300 mg/1 | AvPAK | None |
| 50268-864 | Ursodiol | capsule | 300 mg/1 | AvPAK | None |
| 51407-754 | URSODIOL | capsule | 300 mg/1 | Golden State Medical Supply, Inc. | None |
| 59651-421 | Ursodiol | capsule | 300 mg/1 | Aurobindo Pharma Limited | None |
| 60687-100 | Ursodiol | capsule | 300 mg/1 | American Health Packaging | None |
| 62135-430 | Ursodiol | capsule | 300 mg/1 | Chartwell RX, LLC | None |
| 64380-844 | URSODIOL | capsule | 300 mg/1 | Strides Pharma Science Limited | None |
| 69238-1540 | Ursodiol | capsule | 300 mg/1 | Amneal Pharmaceuticals NY LLC | None |
| 70710-1483 | Ursodiol | capsule | 300 mg/1 | Zydus Pharmaceuticals (USA) Inc. | None |
| 70771-1524 | Ursodiol | capsule | 300 mg/1 | Zydus Lifesciences Limited | None |
| 72162-2168 | Ursodiol | capsule | 300 mg/1 | Bryant Ranch Prepack | None |
| 72162-2619 | Ursodiol | capsule | 300 mg/1 | Bryant Ranch Prepack | None |
| 72603-613 | Ursodiol | capsule | 300 mg/1 | NorthStar Rx LLC | None |
| 72664-217 | Ursodiol | capsule | 300 mg/1 | VGYAAN Pharmaceuticals LLC | None |
| 60687-527 | Ursodiol | tablet | 250 mg/1 | American Health Packaging | None |
| 64380-918 | URSODIOL | tablet | 250 mg/1 | Strides Pharma Science Limited | None |
| 68001-377 | Ursodiol | tablet | 250 mg/1 | BluePoint Laboratories | None |
| 68462-473 | Ursodiol | tablet | 250 mg/1 | Glenmark Pharmaceuticals Inc., USA | None |
| 70710-1127 | Ursodiol | tablet | 250 mg/1 | Zydus Pharmaceuticals (USA) Inc. | None |
| 70771-1407 | Ursodiol | tablet | 250 mg/1 | Zydus Lifesciences Limited | None |
| 64380-919 | URSODIOL | tablet | 500 mg/1 | Strides Pharma Science Limited | None |
| 68001-378 | Ursodiol | tablet | 500 mg/1 | BluePoint Laboratories | None |
| 68462-474 | Ursodiol | tablet | 500 mg/1 | Glenmark Pharmaceuticals Inc., USA | None |
| 70710-1128 | Ursodiol | tablet | 500 mg/1 | Zydus Pharmaceuticals (USA) Inc. | None |
| 70771-1408 | Ursodiol | tablet | 500 mg/1 | Zydus Lifesciences Limited | None |
| 0904-6890 | Ursodiol | tablet, film coated | 250 mg/1 | Major Pharmaceuticals | None |
| 49884-412 | Ursodiol | tablet, film coated | 250 mg/1 | Par Health USA, LLC | None |
| 55154-2633 | Ursodiol | tablet, film coated | 250 mg/1 | Cardinal Health 107, LLC | None |
Showing 40 of 51 listings.
Questions
Is ursodiol a controlled substance?
No. Ursodiol is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and ursodiol is not on the DEA controlled substances list.
Is ursodiol a narcotic?
No. Ursodiol is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Bile Acid.
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.