DEA schedule
Is tacrolimus a controlled substance?
Federal schedule for tacrolimus from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Tacrolimus is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and tacrolimus is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 106 prescription listings from 36 labelers, none with a DEA schedule |
| DEA controlled substances list | tacrolimus is not on the list |
Tacrolimus NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0469-0647 | ASTAGRAF XL | capsule, coated, extended release | .5 mg/1 | Astellas Pharma US, Inc. | None |
| 0469-0677 | ASTAGRAF XL | capsule, coated, extended release | 1 mg/1 | Astellas Pharma US, Inc. | None |
| 0469-0687 | ASTAGRAF XL | capsule, coated, extended release | 5 mg/1 | Astellas Pharma US, Inc. | None |
| 68992-3075 | Envarsus XR | tablet, extended release | .75 mg/1 | Veloxis Pharmaceuticals, Inc | None |
| 68992-3010 | Envarsus XR | tablet, extended release | 1 mg/1 | Veloxis Pharmaceuticals, Inc | None |
| 68992-3040 | Envarsus XR | tablet, extended release | 4 mg/1 | Veloxis Pharmaceuticals, Inc | None |
| 0469-0607 | Prograf | capsule, gelatin coated | .5 mg/1 | Astellas Pharma US, Inc. | None |
| 0469-0617 | Prograf | capsule, gelatin coated | 1 mg/1 | Astellas Pharma US, Inc. | None |
| 0469-0657 | Prograf | capsule, gelatin coated | 5 mg/1 | Astellas Pharma US, Inc. | None |
| 0469-1230 | Prograf | granule, for suspension | .2 mg/1 | Astellas Pharma US, Inc. | None |
| 0469-1330 | Prograf | granule, for suspension | 1 mg/1 | Astellas Pharma US, Inc. | None |
| 0469-3016 | Prograf | injection, solution | 5 mg/mL | Astellas Pharma US, Inc. | None |
| 45802-390 | Tacrolimus | ointment | .3 mg/g | Padagis Israel Pharmaceuticals Ltd | None |
| 45802-700 | Tacrolimus | ointment | 1 mg/g | Padagis Israel Pharmaceuticals Ltd | None |
| 0378-2045 | Tacrolimus | capsule | .5 mg/1 | Mylan Pharmaceuticals Inc. | None |
| 0781-2102 | Tacrolimus | capsule | .5 mg/1 | Sandoz Inc. | None |
| 0904-6623 | Tacrolimus | capsule | .5 mg/1 | Major Pharmaceuticals | None |
| 16714-098 | tacrolimus | capsule | .5 mg/1 | NORTHSTAR RX LLC | None |
| 16729-041 | Tacrolimus | capsule | .5 mg/1 | Accord Healthcare Inc. | None |
| 48433-092 | Tacrolimus | capsule | .5 mg/1 | Safecor Health LLC | None |
| 50268-736 | Tacrolimus | capsule | .5 mg/1 | AvPAK | None |
| 51079-817 | Tacrolimus | capsule | .5 mg/1 | MylanInstitutional Inc. | None |
| 54288-134 | Tacrolimus | capsule | .5 mg/1 | BPI Labs LLC | None |
| 55111-525 | Tacrolimus | capsule | .5 mg/1 | Dr. Reddy's Laboratories Limited | None |
| 60429-377 | Tacrolimus | capsule | .5 mg/1 | Golden State Medical Supply, Inc. | None |
| 63629-8725 | Tacrolimus | capsule | .5 mg/1 | Bryant Ranch Prepack | None |
| 63629-9581 | Tacrolimus | capsule | .5 mg/1 | Bryant Ranch Prepack | None |
| 64380-720 | Tacrolimus | capsule | .5 mg/1 | Strides Pharma Science Limited | None |
| 67877-278 | Tacrolimus | capsule | .5 mg/1 | Ascend Laboratories, LLC | None |
| 68084-449 | Tacrolimus | capsule | .5 mg/1 | American Health Packaging | None |
| 68254-5004 | Tacrolimus | capsule | .5 mg/1 | CONCORD BIOTECH LIMITED | None |
| 68462-685 | tacrolimus | capsule | .5 mg/1 | Glenmark Pharmaceuticals Inc., USA | None |
| 70377-014 | Tacrolimus | capsule | .5 mg/1 | Biocon Pharma Inc. | None |
| 71335-2189 | Tacrolimus | capsule | .5 mg/1 | Bryant Ranch Prepack | None |
| 82009-164 | Tacrolimus | capsule | .5 mg/1 | Quallent Pharmaceuticals Health LLC | None |
| 82983-400 | Tacrolimus | capsule | .5 mg/1 | Ajenat Pharmaceuticals LLC | None |
| 85972-101 | Tacrolimus | capsule | .5 mg/1 | Stellon Biotech Inc. | None |
| 0378-2046 | Tacrolimus | capsule | 1 mg/1 | Mylan Pharmaceuticals Inc. | None |
| 0781-2103 | Tacrolimus | capsule | 1 mg/1 | Sandoz Inc. | None |
| 0904-7097 | Tacrolimus | capsule | 1 mg/1 | Major Pharmaceuticals | None |
Showing 40 of 106 listings.
Questions
Is tacrolimus a controlled substance?
No. Tacrolimus is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and tacrolimus is not on the DEA controlled substances list.
Is tacrolimus a narcotic?
No. Tacrolimus is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Calcineurin 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 Tacrolimus
- What is Tacrolimus used for?FDA label uses
- Generic for Astagraf XLFDA Orange Book
- Generic for PrografFDA Orange Book
- Generic for ProtopicFDA Orange Book
- Generic for Envarsus XRFDA Orange Book
- Calcineurin Inhibitor Immunosuppressants listFDA drug class
- NDC 0469-0607Tacrolimus NDC record
- NDC 0469-0617Tacrolimus NDC record
- NDC 0469-0647Tacrolimus NDC record