budesonide
budesonide is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including budesonide, Uceris, Tarpeyo. Available dosage forms: capsule, capsule, coated pellets, tablet, extended release, aerosol, foam, capsule, delayed release.
Drug Details
- Generic Name
- budesonide
- Brand Names
- budesonide, Uceris, Tarpeyo, BUDESONIDE
- Application Number
- NDA021324
- Sponsor
- Bryant Ranch Prepack
- NDC Codes
- 16
- Dosage Forms
- CAPSULE, CAPSULE, COATED PELLETS, TABLET, EXTENDED RELEASE, AEROSOL, FOAM, CAPSULE, DELAYED RELEASE
- Routes
- ORAL, RECTAL
- Active Ingredients
- BUDESONIDE
Indications and Usage
1 INDICATIONS AND USAGE BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta 2 -adrenergic agonist (LABA), indicated for: • the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1.1 ) • the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use: Not indicated for the relief of acute bronchospasm. ( 1.3 , 5.1 , 5.2 ) 1.1 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BREZTRI AEROSPHERE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. 1.2 Maintenance Treatment of Asthma BREZTRI AEROSPHERE is indicated for the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older. 1.3 Limitations of Use BREZTRI AEROSPHERE is not indicated for the relief of acute bronchospasm [see Warnings and Precautions (5.1 , 5.2) ] .