DEA schedule
Is mesalamine a controlled substance?
Federal schedule for mesalamine from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Mesalamine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and mesalamine is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 62 prescription listings from 38 labelers, none with a DEA schedule |
| DEA controlled substances list | mesalamine is not on the list |
Mesalamine NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 65649-103 | APRISO | capsule, extended release | 375 mg/1 | Salix Pharmaceuticals, Inc. | None |
| 58914-501 | Canasa | suppository | 1000 mg/1 | Allergan, Inc. | None |
| 54092-476 | Lialda | tablet, delayed release | 1.2 g/1 | Takeda Pharmaceuticals America, Inc. | None |
| 54092-189 | Pentasa | capsule | 250 mg/1 | Takeda Pharmaceuticals America, Inc. | None |
| 54092-191 | Pentasa | capsule | 500 mg/1 | Takeda Pharmaceuticals America, Inc. | None |
| 0037-0066 | Rowasa | suspension | 4 g/60mL | Viatris Specialty LLC | None |
| 0093-5907 | Mesalamine | capsule, delayed release | 400 mg/1 | Teva Pharmaceuticals USA, Inc. | None |
| 60687-556 | Mesalamine | capsule, delayed release | 400 mg/1 | American Health Packaging | None |
| 0378-1375 | Mesalamine | capsule, extended release | .375 g/1 | Mylan Pharmaceuticals Inc. | None |
| 0832-6056 | Mesalamine | capsule, extended release | .375 g/1 | Upsher-Smith Laboratories, LLC | None |
| 46708-724 | MESALAMINE | capsule, extended release | .375 g/1 | Alembic Pharmaceuticals Limited | None |
| 50268-577 | Mesalamine | capsule, extended release | .375 g/1 | AvPAK | None |
| 50742-371 | Mesalamine | capsule, extended release | .375 g/1 | Ingenus Pharmaceuticals, LLC | None |
| 51407-976 | Mesalamine | capsule, extended release | .375 g/1 | Golden State Medical Supply, Inc. | None |
| 59651-397 | Mesalamine | capsule, extended release | .375 g/1 | Aurobindo Pharma Limited | None |
| 60687-650 | Mesalamine | capsule, extended release | .375 g/1 | American Health Packaging | None |
| 62332-724 | MESALAMINE | capsule, extended release | .375 g/1 | Alembic Pharmaceuticals Inc. | None |
| 67877-717 | Mesalamine | capsule, extended release | .375 g/1 | Ascend Laboratories, LLC | None |
| 68382-452 | Mesalamine | capsule, extended release | .375 g/1 | Zydus Pharmaceuticals USA Inc. | None |
| 70771-1625 | Mesalamine | capsule, extended release | .375 g/1 | Zydus Lifesciences Limited | None |
| 0781-2791 | Mesalamine | capsule, extended release | 250 mg/1 | Sandoz Inc | None |
| 0093-9224 | mesalamine | capsule, extended release | 375 mg/1 | Teva Pharmaceuticals USA, Inc. | None |
| 31722-489 | MESALAMINE | capsule, extended release | 375 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 0781-2793 | Mesalamine | capsule, extended release | 500 mg/1 | Sandoz Inc | None |
| 63304-089 | Mesalamine | capsule, extended release | 500 mg/1 | Sun Pharmaceutical Industries Inc. | None |
| 45802-098 | Mesalamine | enema | 4 g/60mL | Padagis Israel Pharmaceuticals Ltd | None |
| 62559-420 | Mesalamine | enema | 4 g/60mL | ANI Pharmaceuticals, Inc. | None |
| 0472-1915 | Mesalamine | suppository | 1000 mg/1 | Actavis Pharma, Inc. | None |
| 16571-246 | Mesalamine | suppository | 1000 mg/1 | Rising Pharma Holdings, Inc. | None |
| 16714-245 | Mesalamine | suppository | 1000 mg/1 | Northstar Rx LLC. | None |
| 31722-005 | Mesalamine | suppository | 1000 mg/1 | Camber Pharmaceuticals, Inc. | None |
| 63629-2397 | Mesalamine | suppository | 1000 mg/1 | Bryant Ranch Prepack | None |
| 64980-282 | Mesalamine | suppository | 1000 mg/1 | Rising Pharma Holdings, Inc. | None |
| 70710-1302 | Mesalamine | suppository | 1000 mg/1 | Zydus Pharmaceuticals USA Inc. | None |
| 70771-1513 | Mesalamine | suppository | 1000 mg/1 | Zydus Lifesciences Limited | None |
| 72162-1804 | Mesalamine | suppository | 1000 mg/1 | Bryant Ranch Prepack | None |
| 21922-045 | Mesalamine | suspension | 4 g/60mL | Encube Ethicals, Inc. | None |
| 70954-301 | Mesalamine | suspension | 4 g/60mL | ANI Pharmaceuticals, Inc. | None |
| 72162-2302 | Mesalamine | suspension | 4 g/60mL | Bryant Ranch Prepack | None |
| 84725-002 | MESALAMINE | suspension | 4 g/60mL | KLM Laboratories Private Limited | None |
Showing 40 of 62 listings.
Questions
Is mesalamine a controlled substance?
No. Mesalamine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and mesalamine is not on the DEA controlled substances list.
Is mesalamine a narcotic?
No. Mesalamine is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Aminosalicylate.
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 Mesalamine
- What is Mesalamine used for?FDA label uses
- Generic for DelzicolFDA Orange Book
- Generic for AprisoFDA Orange Book
- Generic for PentasaFDA Orange Book
- Generic for RowasaFDA Orange Book
- Generic for SfrowasaFDA Orange Book
- Generic for CanasaFDA Orange Book
- Generic for Asacol HdFDA Orange Book
- Generic for LialdaFDA Orange Book
- What is Pentasa used for?FDA label uses
- Is Pentasa a controlled substance?Federal schedule
- Aminosalicylates listFDA drug class
- Mesalamine Medicare Part D coverageBy plan and state
- NDC 0037-0066Mesalamine NDC record
- NDC 54092-189Mesalamine NDC record
- NDC 54092-191Mesalamine NDC record