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These highlights do not include all the information needed to use ROFLUMILAST safely and effectively. See full prescribing information for ROFLUMILAST. ROFLUMILAST (roflumilast) TABLET for ORAL use.Initial U.S. Approval: 2011
Medication labelWhy this: Advisory · dailymed-prescription
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.
- generic_name
- roflumilast
- product_names
- roflumilast
- ndc
- 43547-005, 43547-005-03, 43547-005-09
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en