DEA schedule
Is roflumilast a controlled substance?
Federal schedule for roflumilast from the FDA NDC directory, checked against the DEA controlled substances list.
Source: FDA NDC Directory file dated 2026-10-22. Publisher page
No. Roflumilast is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and roflumilast is not on the DEA controlled substances list.
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Schedule check
| Source | What it lists |
|---|---|
| FDA NDC directory | 33 prescription listings from 18 labelers, none with a DEA schedule |
| DEA controlled substances list | roflumilast is not on the list |
Roflumilast NDC listings
| NDC | Product | Form | Strength | Labeler | DEA schedule |
|---|---|---|---|---|---|
| 0310-0088 | Daliresp | tablet | 250 ug/1 | AstraZeneca Pharmaceuticals LP | None |
| 0310-0095 | Daliresp | tablet | 500 ug/1 | AstraZeneca Pharmaceuticals LP | None |
| 80610-430 | ZORYVE | aerosol, foam | 3 mg/g | Arcutis Biotherapeutics, Inc. | None |
| 80610-105 | ZORYVE | cream | .5 mg/g | Arcutis Biotherapeutics, Inc. | None |
| 80610-115 | ZORYVE | cream | 1.5 mg/g | Arcutis Biotherapeutics, Inc. | None |
| 80610-130 | ZORYVE | cream | 3 mg/g | Arcutis Biotherapeutics, Inc. | None |
| 0904-7493 | Roflumilast | tablet | 250 ug/1 | MAJOR PHARMACEUTICALS | None |
| 31722-676 | Roflumilast | tablet | 250 ug/1 | Camber Pharmaceuticals, Inc. | None |
| 42571-369 | ROFLUMILAST | tablet | 250 ug/1 | Micro Labs Limited | None |
| 59651-801 | ROFLUMILAST | tablet | 250 ug/1 | Aurobindo Pharma Limited | None |
| 59746-801 | Roflumilast | tablet | 250 ug/1 | Jubilant Cadista Pharmaceuticals Inc. | None |
| 67877-730 | Roflumilast | tablet | 250 ug/1 | Ascend Laboratories, LLC | None |
| 68382-624 | Roflumilast | tablet | 250 ug/1 | Zydus Pharmaceuticals USA Inc. | None |
| 69292-630 | ROFLUMILAST | tablet | 250 ug/1 | Amici Pharma Inc. | None |
| 70771-1673 | Roflumilast | tablet | 250 ug/1 | Zydus Lifesciences Limited | None |
| 72205-201 | Roflumilast | tablet | 250 ug/1 | Novadoz Pharmaceuticals LLC | None |
| 73190-086 | roflumilast | tablet | 250 ug/1 | AvKARE | None |
| 0904-7399 | Roflumilast | tablet | 500 ug/1 | MAJOR PHARMACEUTICALS | None |
| 0904-7483 | Roflumilast | tablet | 500 ug/1 | Major Pharmaceuticals | None |
| 31722-623 | Roflumilast | tablet | 500 ug/1 | Camber Pharmaceuticals, Inc. | None |
| 42571-259 | ROFLUMILAST | tablet | 500 ug/1 | Micro Labs Limited | None |
| 43547-005 | ROFLUMILAST | tablet | 500 ug/1 | Solco Healthcare US, LLC. | None |
| 51407-975 | Roflumilast | tablet | 500 ug/1 | Golden State Medical Supply, Inc. | None |
| 59651-275 | ROFLUMILAST | tablet | 500 ug/1 | Aurobindo Pharma Limited | None |
| 59746-802 | Roflumilast | tablet | 500 ug/1 | Jubilant Cadista Pharmaceuticals Inc. | None |
| 60687-786 | Roflumilast | tablet | 500 ug/1 | American Health Packaging | None |
| 67877-480 | Roflumilast | tablet | 500 ug/1 | Ascend Laboratories, LLC | None |
| 68382-969 | Roflumilast | tablet | 500 ug/1 | Zydus Pharmaceuticals USA Inc. | None |
| 69292-631 | ROFLUMILAST | tablet | 500 ug/1 | Amici Pharma Inc. | None |
| 70771-1674 | Roflumilast | tablet | 500 ug/1 | Zydus Lifesciences Limited | None |
| 72162-2385 | ROFLUMILAST | tablet | 500 ug/1 | Bryant Ranch Prepack | None |
| 72205-200 | Roflumilast | tablet | 500 ug/1 | Novadoz Pharmaceuticals LLC | None |
| 73190-087 | roflumilast | tablet | 500 ug/1 | AvKARE | None |
Questions
Is roflumilast a controlled substance?
No. Roflumilast is not a federally controlled substance. None of its FDA NDC listings carries a DEA schedule, and roflumilast is not on the DEA controlled substances list.
Is roflumilast a narcotic?
No. Roflumilast is not on the DEA controlled substances list, so the DEA does not classify it as a narcotic. Its FDA established pharmacologic class is Phosphodiesterase 4 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 Roflumilast
- What is Roflumilast used for?FDA label uses
- Generic for ZoryveFDA Orange Book
- Generic for DalirespFDA Orange Book
- What is Zoryve used for?FDA label uses
- Is Zoryve a controlled substance?Federal schedule
- Phosphodiesterase 4 Inhibitors listFDA drug class
- NDC 0310-0088Roflumilast NDC record
- NDC 0310-0095Roflumilast NDC record
- NDC 80610-105Roflumilast NDC record