DEA schedule
Is fluoxetine a controlled substance?
Federal schedule for fluoxetine from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Fluoxetine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and fluoxetine is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 227 prescription listings from 60 labelers, none with a DEA schedule |
| DEA controlled substances list | fluoxetine is not on the list |
Fluoxetine NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0777-3104 | Prozac | capsule | 10 mg/1 | Dista Products Company | None |
| 0777-3105 | Prozac | capsule | 20 mg/1 | Dista Products Company | None |
| 0777-3107 | Prozac | capsule | 40 mg/1 | Dista Products Company | None |
| 0615-8093 | Fluoxetine | capsule | 10 mg/1 | NCS HealthCare of KY, LLC dba Vangard Labs | None |
| 0904-7345 | Fluoxetine | capsule | 10 mg/1 | Major Pharmaceuticals | None |
| 16714-720 | Fluoxetine | capsule | 10 mg/1 | NorthStar Rx LLC | None |
| 17224-171 | Fluoxetine | capsule | 10 mg/1 | Calvin Scott & Co., Inc. | None |
| 23155-028 | FLUOXETINE | capsule | 10 mg/1 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | None |
| 25000-147 | Fluoxetine | capsule | 10 mg/1 | MARKSANS PHARMA LIMITED | None |
| 42543-725 | Fluoxetine | capsule | 10 mg/1 | Vensun Pharmaceuticals, Inc. | None |
| 43063-570 | Fluoxetine | capsule | 10 mg/1 | PD-Rx Pharmaceuticals, Inc. | None |
| 46708-271 | Fluoxetine | capsule | 10 mg/1 | Alembic Pharmaceuticals Limited | None |
| 49483-701 | Fluoxetine | capsule | 10 mg/1 | TIME CAP LABORATORIES, INC. | None |
| 50090-6065 | Fluoxetine | capsule | 10 mg/1 | A-S Medication Solutions | None |
| 50090-6193 | Fluoxetine | capsule | 10 mg/1 | A-S Medication Solutions | None |
| 50090-6702 | Fluoxetine | capsule | 10 mg/1 | A-S Medication Solutions | None |
| 50111-647 | Fluoxetine | capsule | 10 mg/1 | Teva Pharmaceuticals USA, Inc. | None |
| 50228-113 | Fluoxetine | capsule | 10 mg/1 | ScieGen Pharmaceuticals, Inc. | None |
| 51655-314 | Fluoxetine | capsule | 10 mg/1 | Northwind Health Company, LLC | None |
| 51655-750 | Fluoxetine | capsule | 10 mg/1 | Northwind Health Company, LLC | None |
| 59651-898 | Fluoxetine | capsule | 10 mg/1 | Aurobindo Pharma Limited | None |
| 62332-022 | Fluoxetine | capsule | 10 mg/1 | Alembic Pharmaceuticals Inc. | None |
| 63187-081 | Fluoxetine | capsule | 10 mg/1 | Proficient Rx LP | None |
| 63187-233 | Fluoxetine | capsule | 10 mg/1 | Proficient Rx LP | None |
| 63629-1609 | Fluoxetine | capsule | 10 mg/1 | Bryant Ranch Prepack | None |
| 65862-192 | Fluoxetine | capsule | 10 mg/1 | Aurobindo Pharma Limited | None |
| 67046-1695 | Fluoxetine | capsule | 10 mg/1 | Coupler LLC | None |
| 67046-2083 | Fluoxetine | capsule | 10 mg/1 | Coupler LLC | None |
| 68001-399 | Fluoxetine | capsule | 10 mg/1 | BluePoint Laboratories | None |
| 68001-670 | Fluoxetine | capsule | 10 mg/1 | BluePoint Laboratories | None |
| 68071-2275 | Fluoxetine | capsule | 10 mg/1 | NuCare Pharmaceuticals,Inc. | None |
| 68071-4606 | Fluoxetine | capsule | 10 mg/1 | NuCare Pharmaceuticals,Inc. | None |
| 68645-131 | Fluoxetine | capsule | 10 mg/1 | Legacy Pharmaceutical Packaging, LLC | None |
| 68788-7817 | Fluoxetine | capsule | 10 mg/1 | Preferred Pharmaceuticals, Inc. | None |
| 70518-1174 | Fluoxetine | capsule | 10 mg/1 | REMEDYREPACK INC. | None |
| 70518-3483 | Fluoxetine | capsule | 10 mg/1 | REMEDYREPACK INC. | None |
| 70518-3752 | Fluoxetine | capsule | 10 mg/1 | REMEDYREPACK INC. | None |
| 70518-4611 | Fluoxetine | capsule | 10 mg/1 | REMEDYREPACK INC. | None |
| 71205-974 | Fluoxetine | capsule | 10 mg/1 | Proficient Rx LP | None |
| 71209-040 | Fluoxetine | capsule | 10 mg/1 | Cadila Pharmaceuticals Limited | None |
Showing 40 of 227 listings.
Questions
Is fluoxetine a controlled substance?
No. Fluoxetine is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and fluoxetine is not on the DEA controlled substances list.
Is fluoxetine a narcotic?
No. Fluoxetine is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Serotonin Reuptake 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 Fluoxetine
- What is Fluoxetine used for?FDA label uses
- Generic for Prozac WeeklyFDA Orange Book
- Generic for ProzacFDA Orange Book
- Generic for SarafemFDA Orange Book
- What is Prozac used for?FDA label uses
- Is Prozac a controlled substance?Federal schedule
- Serotonin Reuptake Inhibitors listFDA drug class
- NDC 0777-3104Fluoxetine NDC record
- NDC 0777-3105Fluoxetine NDC record
- NDC 0777-3107Fluoxetine NDC record