Quick answers
- What is Roflumilast used for?
- The FDA-approved label (Daliresp, AstraZeneca Pharmaceuticals LP, March 12, 2020) says: “DALIRESP ® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Roflumilast have a boxed warning?
- No. None of the 18 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Roflumilast?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Roflumilast been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Roflumilast?
- 17 companies list prescription products of Roflumilast in the FDA NDC Directory, including Arcutis Biotherapeutics, Inc., Major Pharmaceuticals and Novadoz Pharmaceuticals LLC.
What Roflumilast is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DALIRESP ® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. …
— FDA label: Daliresp, AstraZeneca Pharmaceuticals LP, effective March 12, 2020. Read the full label on DailyMed →
The FDA has 18 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| roflumilast 0.05% cream | Brand: Zoryve | $15.39 per gram |
| roflumilast 0.15% cream | Brand: Zoryve | $15.40 per gram |
| roflumilast 0.3% aerosol, foam | Brand: Zoryve | $15.38 per gram |
| roflumilast 0.3% cream | Brand: Zoryve | $15.38 per gram |
| roflumilast 250 ug tablet | Generic | $1.80 per tablet |
| roflumilast 250 ug tablet | Brand: Daliresp | $14.98 per tablet |
| roflumilast 500 ug tablet | Generic | $0.3025 per tablet |
| roflumilast 500 ug tablet | Brand: Daliresp | $14.92 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Arcutis Biotherapeutics, Inc.4 products
- Major Pharmaceuticals3 products
- Novadoz Pharmaceuticals LLC2 products
- Aurobindo Pharma Limited2 products
- Ascend Laboratories, LLC2 products
- Amici Pharma, Inc.2 products
- Micro Labs Limited2 products
- Zydus Pharmaceuticals USA Inc.2 products
- AvKARE2 products
- AstraZeneca Pharmaceuticals LP2 products
- Zydus Lifesciences Limited2 products
- Jubilant Cadista Pharmaceuticals Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Bryant Ranch Prepack1 product
- Solco Healthcare US, LLC1 product
- Golden State Medical Supply, Inc.1 product
- American Health Packaging1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022522 DALIRESP | Astrazeneca | February 28, 2011 | 8, latest January 23, 2018 2018: Efficacy · 2017: Efficacy · 2016: Manufacturing (CMC) |
| NDA215985 ZORYVE | Arcutis | July 29, 2022 | 4, latest June 29, 2026 2026: Efficacy · 2025: Efficacy · 2024: Efficacy |
| NDA217242 ZORYVE | Arcutis | December 15, 2023 | 2, latest May 22, 2025 2025: Efficacy · 2024: Manufacturing (CMC) |
Generic approvals (9)
- ANDA208236Pharmazone · October 3, 2018
- ANDA208213Hetero Labs Ltd III · November 23, 2018
- ANDA208180Micro Labs · March 22, 2019
- ANDA208247Strides Pharma · March 30, 2020
- ANDA208303Zydus Pharms · February 10, 2022
- ANDA208299Prinston Inc · May 10, 2022
- ANDA208256Msn · September 7, 2022
- ANDA213298Aurobindo Pharma Ltd · April 17, 2023
- ANDA212490Alkem Labs Ltd · April 18, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Daliresp, AstraZeneca Pharmaceuticals LP, effective March 12, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →