DEA schedule
Is fluorouracil a controlled substance?
Federal schedule for fluorouracil from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Fluorouracil is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and fluorouracil 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 23 labelers, none with a DEA schedule |
| DEA controlled substances list | fluorouracil is not on the list |
Fluorouracil NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0187-3204 | Efudex | cream | 2 g/40g | Bausch Health US, LLC | None |
| 83831-143 | FAVLYXA | injection, solution | 25 mg/mL | Avyxa Pharma, LLC | None |
| 83831-164 | FAVLYXA | injection, solution | 25 mg/mL | Avyxa Pharma, LLC | None |
| 28105-421 | TOLAK | cream | .04 g/g | HILL DERMACEUTICALS, INC. | None |
| 21922-049 | FLUOROURACIL | cream | 2 g/40g | Encube Ethicals, Inc. | None |
| 0378-4791 | Fluorouracil | cream | 5 mg/g | Mylan Pharmaceuticals Inc. | None |
| 75907-169 | FLUOROURACIL | cream | 5 mg/g | Dr. Reddy's Laboratories Inc. | None |
| 16714-178 | Fluorouracil | cream | 50 mg/g | NORTHSTAR RX LLC | None |
| 16729-542 | Fluorouracil | cream | 50 mg/g | Accord Healthcare Inc. | None |
| 51672-4118 | Fluorouracil | cream | 50 mg/g | Sun Pharmaceutical Industries, Inc. | None |
| 51862-362 | FLUOROURACIL | cream | 50 mg/g | Mayne Pharma Inc. | None |
| 75907-095 | FLUOROURACIL | cream | 50 mg/g | Dr. Reddy's Labratories Inc. | None |
| 16729-276 | Fluorouracil | injection, solution | 50 mg/mL | Accord Healthcare, Inc. | None |
| 16729-276 | Fluorouracil | injection, solution | 50 mg/mL | Accord Healthcare, Inc. | None |
| 23155-972 | FLUOROURACIL | injection, solution | 50 mg/mL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | None |
| 23155-973 | FLUOROURACIL | injection, solution | 50 mg/mL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | None |
| 23155-974 | FLUOROURACIL | injection, solution | 50 mg/mL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | None |
| 23155-975 | FLUOROURACIL | injection, solution | 50 mg/mL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | None |
| 25021-215 | fluorouracil | injection, solution | 50 mg/mL | Sagent Pharmaceuticals | None |
| 46708-751 | Fluorouracil | injection, solution | 50 mg/mL | Alembic Pharmaceuticals Limited | None |
| 46708-779 | Fluorouracil | injection, solution | 50 mg/mL | Alembic Pharmaceuticals Limited | None |
| 55150-496 | FLUOROURACIL | injection, solution | 50 mg/mL | Eugia US LLC | None |
| 55150-497 | FLUOROURACIL | injection, solution | 50 mg/mL | Eugia US LLC | None |
| 55150-498 | FLUOROURACIL | injection, solution | 50 mg/mL | Eugia US LLC | None |
| 55150-499 | FLUOROURACIL | injection, solution | 50 mg/mL | Eugia US LLC | None |
| 62332-751 | Fluorouracil | injection, solution | 50 mg/mL | Alembic Pharmaceuticals Inc. | None |
| 62332-779 | Fluorouracil | injection, solution | 50 mg/mL | Alembic Pharmaceuticals Inc. | None |
| 63323-117 | Fluorouracil | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 63323-117 | Fluorouracil | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 63323-117 | Fluorouracil | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 63323-117 | Fluorouracil | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 63323-117 | Fluorouracil | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 63323-117 | Fluorouracil | injection, solution | 50 mg/mL | Fresenius Kabi USA, LLC | None |
| 68001-524 | Fluorouracil | injection, solution | 50 mg/mL | BluePoint Laboratories | None |
| 68001-525 | Fluorouracil | injection, solution | 50 mg/mL | BluePoint Laboratories | None |
| 68001-627 | Fluorouracil | injection, solution | 50 mg/mL | BluePoint Laboratories | None |
| 68001-628 | Fluorouracil | injection, solution | 50 mg/mL | BluePoint Laboratories | None |
| 68083-269 | Fluorouracil | injection, solution | 50 mg/mL | Gland Pharma Limited | None |
| 68083-270 | Fluorouracil | injection, solution | 50 mg/mL | Gland Pharma Limited | None |
| 68083-292 | Fluorouracil | injection, solution | 50 mg/mL | Gland Pharma Limited | None |
Showing 40 of 51 listings.
Questions
Is fluorouracil a controlled substance?
No. Fluorouracil is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and fluorouracil is not on the DEA controlled substances list.
Is fluorouracil a narcotic?
No. Fluorouracil is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Nucleoside Metabolic Inhibitor.
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 Fluorouracil
- What is Fluorouracil used for?FDA label uses
- Generic for CaracFDA Orange Book
- Generic for EfudexFDA Orange Book
- Generic for TolakFDA Orange Book
- Generic for FavlyxaFDA Orange Book
- Nucleoside Metabolic Inhibitors listFDA drug class
- NDC 0187-3204Fluorouracil NDC record
- NDC 28105-421Fluorouracil NDC record
- NDC 83831-143Fluorouracil NDC record