roflumilast
roflumilast is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand names including ZORYVE, Roflumilast, ROFLUMILAST. Available dosage forms: cream, tablet, aerosol, foam.
Drug Details
- Generic Name
- roflumilast
- Brand Names
- ZORYVE, Roflumilast, ROFLUMILAST, Daliresp
- Application Number
- NDA215985
- Sponsor
- Arcutis Biotherapeutics, Inc.
- NDC Codes
- 17
- Dosage Forms
- CREAM, TABLET, AEROSOL, FOAM
- Routes
- TOPICAL, ORAL
- Active Ingredients
- ROFLUMILAST
Indications and Usage
1 INDICATIONS AND USAGE Roflumilast 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. Limitations of Use Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast 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. ( 1 , 14 ) Limitations of Use: • Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm. ( 1 , 14 )