montelukast sodium
montelukast sodium is listed in the FDA National Drug Code directory with 24 NDC codes, marketed under brand names including montelukast sodium, SINGULAIR. Available dosage forms: tablet, chewable, tablet, film coated, granule, powder.
Drug Details
- Generic Name
- montelukast sodium
- Brand Names
- montelukast sodium, SINGULAIR
- Application Number
- ANDA208621
- Sponsor
- Unichem Pharmaceuticals (USA), Inc.
- NDC Codes
- 24
- Dosage Forms
- TABLET, CHEWABLE, TABLET, FILM COATED, GRANULE, POWDER
- Routes
- ORAL
- Active Ingredients
- MONTELUKAST SODIUM, MONTELUKAST
Indications and Usage
1. INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 2 years of age and older (1.1). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older (1.2). • Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older , and perennial allergic rhinitis (PAR) in patients 2 years of age and older (1.3). 1.1 Asthma Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. 1.2 Exercise-Induced Bronchoconstriction Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp's montelukast tablet products. However , due to Merck Sharp & Dohme Corp's marketing exclusivity rights , this drug product is not labeled with that pediatric information. 1.3 Allergic Rhinitis Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older.