DEA schedule
Is sirolimus a controlled substance?
Federal schedule for sirolimus from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Sirolimus is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and sirolimus is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 39 prescription listings from 21 labelers, none with a DEA schedule |
| DEA controlled substances list | sirolimus is not on the list |
Sirolimus NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 80803-153 | FYARRO | injection, powder, lyophilized, for suspension | 5 mg/mL | Aadi Bioscience, Inc. | None |
| 73683-101 | HYFTOR | gel | 2 mg/g | Nobelpharma America, LLC | None |
| 16571-806 | Sirolimus | solution | 1 mg/mL | Rising Pharma Holdings, Inc. | None |
| 31722-316 | SIROLIMUS | solution | 1 mg/mL | Camber Pharmaceuticals, Inc. | None |
| 59762-1205 | Sirolimus | solution | 1 mg/mL | Mylan Pharmaceuticals Inc. | None |
| 60505-6197 | Sirolimus | solution | 1 mg/mL | Apotex Corp | None |
| 66689-347 | Sirolimus | solution | 1 mg/mL | VistaPharm, LLC | None |
| 69238-1594 | Sirolimus | solution | 1 mg/mL | Amneal Pharmaceuticals NY LLC | None |
| 72162-2641 | sirolimus | solution | 1 mg/mL | Bryant Ranch Prepack | None |
| 72205-099 | sirolimus | solution | 1 mg/mL | Novadoz Pharmaceuticals LLC | None |
| 72603-409 | sirolimus | solution | 1 mg/mL | Northstar Rx LLC | None |
| 70518-3546 | Sirolimus | tablet | .5 mg/1 | REMEDYREPACK INC. | None |
| 50268-718 | Sirolimus | tablet | 1 mg/1 | AvPAK | None |
| 55111-653 | Sirolimus | tablet | 1 mg/1 | Dr. Reddy's Laboratories Limited | None |
| 68084-915 | Sirolimus | tablet | 1 mg/1 | American Health Packaging | None |
| 70518-3795 | Sirolimus | tablet | 1 mg/1 | REMEDYREPACK INC. | None |
| 55111-654 | Sirolimus | tablet | 2 mg/1 | Dr. Reddy's Laboratories Limited | None |
| 16714-187 | sirolimus | tablet, film coated | .5 mg/1 | NORTHSTAR RX LLC | None |
| 60687-902 | sirolimus | tablet, film coated | .5 mg/1 | American Health Packaging | None |
| 65841-771 | sirolimus | tablet, film coated | .5 mg/1 | Zydus Lifesciences Limited | None |
| 67877-746 | Sirolimus | tablet, film coated | .5 mg/1 | Ascend Laboratories, LLC | None |
| 68382-520 | sirolimus | tablet, film coated | .5 mg/1 | Zydus Pharmaceuticals USA Inc. | None |
| 68462-682 | sirolimus | tablet, film coated | .5 mg/1 | Glenmark Pharmaceuticals Inc., USA | None |
| 70518-4376 | sirolimus | tablet, film coated | .5 mg/1 | REMEDYREPACK INC. | None |
| 70518-4449 | sirolimus | tablet, film coated | .5 mg/1 | REMEDYREPACK INC. | None |
| 0904-7248 | Sirolimus | tablet, film coated | 1 mg/1 | Major Pharmaceuticals | None |
| 16714-188 | sirolimus | tablet, film coated | 1 mg/1 | NORTHSTAR RX LLC | None |
| 65841-772 | sirolimus | tablet, film coated | 1 mg/1 | Zydus Lifesciences Limited | None |
| 67877-747 | Sirolimus | tablet, film coated | 1 mg/1 | Ascend Laboratories, LLC | None |
| 68382-351 | sirolimus | tablet, film coated | 1 mg/1 | Zydus Pharmaceuticals USA Inc. | None |
| 68462-683 | sirolimus | tablet, film coated | 1 mg/1 | Glenmark Pharmaceuticals Inc., USA | None |
| 16714-189 | sirolimus | tablet, film coated | 2 mg/1 | NORTHSTAR RX LLC | None |
| 65841-773 | sirolimus | tablet, film coated | 2 mg/1 | Zydus Lifesciences Limited | None |
| 67877-748 | Sirolimus | tablet, film coated | 2 mg/1 | Ascend Laboratories, LLC | None |
| 68382-352 | sirolimus | tablet, film coated | 2 mg/1 | Zydus Pharmaceuticals USA Inc. | None |
| 68462-684 | sirolimus | tablet, film coated | 2 mg/1 | Glenmark Pharmaceuticals Inc., USA | None |
| 59762-1001 | Sirolimus | tablet, sugar coated | .5 mg/1 | Mylan Pharmaceuticals Inc. | None |
| 59762-1002 | Sirolimus | tablet, sugar coated | 1 mg/1 | Mylan Pharmaceuticals Inc. | None |
| 59762-1003 | Sirolimus | tablet, sugar coated | 2 mg/1 | Mylan Pharmaceuticals Inc. | None |
Questions
Is sirolimus a controlled substance?
No. Sirolimus is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and sirolimus is not on the DEA controlled substances list.
Is sirolimus a narcotic?
No. Sirolimus is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Kinase Inhibitor and mTOR Inhibitor Immunosuppressant.
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 Sirolimus
- What is Sirolimus used for?FDA label uses
- Generic for HyftorFDA Orange Book
- Generic for FyarroFDA Orange Book
- Generic for RapamuneFDA Orange Book
- Kinase Inhibitors listFDA drug class
- MTOR Inhibitor Immunosuppressants listFDA drug class
- NDC 73683-101Sirolimus NDC record
- NDC 80803-153Sirolimus NDC record
- NDC 0904-7248Sirolimus NDC record