DEA schedule
Is fentanyl a controlled substance?
Federal schedule for fentanyl from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
Yes. Fentanyl is a Schedule II controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Fentanyl (Schedule II).
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 54 prescription listings from 10 labelers, all Schedule II |
| DEA controlled substances list | Fentanyl: Schedule II |
DEA list entry
| Substance | DEA code | Schedule | Narcotic | Other names | Match |
|---|---|---|---|---|---|
| Fentanyl | 9801 | II | Yes | Duragesic; Oralet; Actiq; Sublimaze; Innovar | Listed by name |
Fentanyl NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0641-6027 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6028 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6029 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6030 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6247 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6248 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6249 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6289 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 0641-6290 | Fentanyl Citrate | injection | 50 ug/mL | Hikma Pharmaceuticals USA Inc. | CII |
| 72572-170 | Fentanyl Citrate | injection | 50 ug/mL | Civica, Inc. | CII |
| 72572-171 | Fentanyl Citrate | injection | 50 ug/mL | Civica, Inc. | CII |
| 72572-172 | Fentanyl Citrate | injection | 50 ug/mL | Civica, Inc. | CII |
| 81565-205 | Fentanyl Citrate | injection | 50 ug/mL | Phlow Corp. | CII |
| 0409-9093 | FENTANYL CITRATE | injection, solution | 50 ug/mL | Hospira, Inc. | CII |
| 0409-9094 | Fentanyl Citrate | injection, solution | 50 ug/mL | Hospira, Inc. | CII |
| 0378-9124 | FENTANYL | patch | 100 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 0378-9119 | FENTANYL | patch | 12 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 0378-9121 | FENTANYL | patch | 25 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 0378-9125 | FENTANYL | patch | 37.5 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 0378-9122 | FENTANYL | patch | 50 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 0378-9126 | FENTANYL | patch | 62.5 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 0378-9123 | FENTANYL | patch | 75 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 0378-9127 | FENTANYL | patch | 87.5 ug/h | Mylan Pharmaceuticals Inc. | CII |
| 3215-7708 | FENTANYL | patch, extended release | 100 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-556 | FENTANYL | patch, extended release | 100 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 3215-7701 | FENTANYL | patch, extended release | 12 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-549 | FENTANYL | patch, extended release | 12 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 3215-7702 | FENTANYL | patch, extended release | 25 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-550 | FENTANYL | patch, extended release | 25 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 3215-7703 | FENTANYL | patch, extended release | 37.5 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-551 | FENTANYL | patch, extended release | 37.5 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 3215-7704 | FENTANYL | patch, extended release | 50 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-552 | FENTANYL | patch, extended release | 50 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 3215-7705 | FENTANYL | patch, extended release | 62.5 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-553 | FENTANYL | patch, extended release | 62.5 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 3215-7706 | FENTANYL | patch, extended release | 75 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-554 | FENTANYL | patch, extended release | 75 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 3215-7707 | FENTANYL | patch, extended release | 87.5 ug/h | Aveva Drug Delivery Systems Inc. | CII |
| 50742-555 | FENTANYL | patch, extended release | 87.5 ug/h | INGENUS PHARMACEUTICALS, LLC | CII |
| 63323-806 | Fentanyl Citrate | injection, solution | .05 mg/mL | Fresenius Kabi USA, LLC | CII |
Showing 40 of 54 listings.
Questions
Is fentanyl a controlled substance?
Yes. Fentanyl is a Schedule II controlled substance under the federal Controlled Substances Act. Matching DEA list entry: Fentanyl (Schedule II).
Is fentanyl a narcotic?
Yes. The DEA list marks fentanyl as a narcotic (NARC = Y) and places it in Schedule II. Its FDA established pharmacologic class is Opioid Agonist.
What schedule is fentanyl?
Fentanyl is Schedule II in the FDA NDC directory, which matches the DEA controlled substances list.
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 Fentanyl
- What is Fentanyl used for?FDA label uses
- Generic for Duragesic-100FDA Orange Book
- Generic for Duragesic-12FDA Orange Book
- Generic for Duragesic-25FDA Orange Book
- Generic for Duragesic-37FDA Orange Book
- Generic for Duragesic-50FDA Orange Book
- Generic for Duragesic-75FDA Orange Book
- Generic for Sublimaze Preservative FreeFDA Orange Book
- Opioid Agonists listFDA drug class
- NDC 0409-9093Fentanyl NDC record
- NDC 0409-9094Fentanyl NDC record
- NDC 0641-6027Fentanyl NDC record
- Schedule II drugs listDEA schedule