DEA schedule

Is leflunomide a controlled substance?

Federal schedule for leflunomide from the FDA NDC directory, checked against the DEA controlled substances list.

Source: FDA NDC Directory file dated 2026-10-22. Publisher page

No. Leflunomide is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and leflunomide is not on the DEA controlled substances list.

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Schedule check

Schedule sources for Leflunomide
SourceWhat it lists
FDA NDC directory40 prescription listings from 17 labelers, none with a DEA schedule
DEA controlled substances listleflunomide is not on the list

Leflunomide NDC listings

NDC listings for Leflunomide
NDCProductFormStrengthLabelerDEA schedule
0088-2160Aravatablet, film coated10 mg/1sanofi-aventis U.S. LLCNone
0088-2162Aravatablet, film coated100 mg/1sanofi-aventis U.S. LLCNone
0088-2161Aravatablet, film coated20 mg/1sanofi-aventis U.S. LLCNone
10702-277Leflunomidetablet10 mg/1KVK-Tech, Inc.None
23155-043leflunomidetablet10 mg/1Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.None
42291-420LEFLUNOMIDEtablet10 mg/1AvKARENone
46708-436Leflunomidetablet10 mg/1Alembic Pharmaceuticals LimitedNone
50268-477LEFLUNOMIDEtablet10 mg/1AvPAKNone
60505-2502LEFLUNOMIDEtablet10 mg/1Apotex Corp.None
62135-793Leflunomidetablet10 mg/1Chartwell RX, LLCNone
62332-061Leflunomidetablet10 mg/1Alembic Pharmaceuticals Inc.None
71335-2874leflunomidetablet10 mg/1Bryant Ranch PrepackNone
72162-2409leflunomidetablet10 mg/1Bryant Ranch PrepackNone
10702-278Leflunomidetablet20 mg/1KVK-Tech, Inc.None
23155-044leflunomidetablet20 mg/1Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.None
42291-421LEFLUNOMIDEtablet20 mg/1AvKARENone
46708-437Leflunomidetablet20 mg/1Alembic Pharmaceuticals LimitedNone
50268-478LEFLUNOMIDEtablet20 mg/1AvPAKNone
60505-2503LEFLUNOMIDEtablet20 mg/1Apotex Corp.None
62135-794Leflunomidetablet20 mg/1Chartwell RX, LLCNone
62332-062Leflunomidetablet20 mg/1Alembic Pharmaceuticals Inc.None
71335-2832leflunomidetablet20 mg/1Bryant Ranch PrepackNone
72162-2410leflunomidetablet20 mg/1Bryant Ranch PrepackNone
35573-447Leflunomidetablet, film coated10 mg/1Burel Pharmaceuticals, LLCNone
59651-348Leflunomidetablet, film coated10 mg/1Aurobindo Pharma LimitedNone
63629-9728Leflunomidetablet, film coated10 mg/1Bryant Ranch PrepackNone
68071-3763Leflunomidetablet, film coated10 mg/1NuCare Pharmaceuticals, Inc.None
70710-1157leflunomidetablet, film coated10 mg/1Zydus Pharmaceuticals (USA) Inc.None
70748-129Leflunomidetablet, film coated10 mg/1Lupin Pharmaceuticals, Inc.None
70771-1491leflunomidetablet, film coated10 mg/1Zydus Lifesciences LimitedNone
35573-448Leflunomidetablet, film coated20 mg/1Burel Pharmaceuticals, LLCNone
50090-5992Leflunomidetablet, film coated20 mg/1A-S Medication SolutionsNone
50090-7537leflunomidetablet, film coated20 mg/1A-S Medication SolutionsNone
59651-349Leflunomidetablet, film coated20 mg/1Aurobindo Pharma LimitedNone
68071-3764leflunomidetablet, film coated20 mg/1NuCare Pharmaceuticals, Inc.None
70710-1158leflunomidetablet, film coated20 mg/1Zydus Pharmaceuticals (USA) Inc.None
70748-130Leflunomidetablet, film coated20 mg/1Lupin Pharmaceuticals, Inc.None
70771-1492leflunomidetablet, film coated20 mg/1Zydus Lifesciences LimitedNone
71335-2256Leflunomidetablet, film coated20 mg/1Bryant Ranch PrepackNone
71335-2403leflunomidetablet, film coated20 mg/1Bryant Ranch PrepackNone

Questions

Is leflunomide a controlled substance?

No. Leflunomide is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and leflunomide is not on the DEA controlled substances list.

Is leflunomide a narcotic?

No. Leflunomide is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Antirheumatic Agent.

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.

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