nintedanib
nintedanib is listed in the FDA National Drug Code directory with 18 NDC codes, marketed under brand names including Nintedanib, nintedanib, Ofev. Available dosage form: capsule.
Drug Details
- Generic Name
- nintedanib
- Brand Names
- Nintedanib, nintedanib, Ofev
- Application Number
- ANDA219819
- Sponsor
- Golden State Medical Supply, Inc.
- NDC Codes
- 18
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- NINTEDANIB ESYLATE
Indications and Usage
1 INDICATIONS AND USAGE Nintedanib capsules are a kinase inhibitor indicated in adults for: • Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) • Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) • Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis Nintedanib capsules are indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsules are indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies ( 14.2 )] . 1.3 Systemic Sclerosis-Associated Interstitial Lung Disease Nintedanib capsules are indicated to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).