esomeprazole
esomeprazole is listed in the FDA National Drug Code directory with 22 NDC codes, marketed under brand names including esomeprazole magnesium, esomeprazole, Esomeprazole Magnesium. Available dosage form: capsule, delayed release.
Drug Details
- Generic Name
- esomeprazole
- Brand Names
- esomeprazole magnesium, esomeprazole, Esomeprazole Magnesium, good sense esomeprazole magnesium, Esomeprazole, basic care esomeprazole magnesium, members mark esomeprazole magnesium, dg health esomeprazole magnesium, Basic Care Esomeprazole Magnesium, signature care esomeprazole magnesium, EQUATE ESOMEPRAZOLE MAGNESIUM, Good Neighbor Pharmacy Esomeprazole Magnesium
- Application Number
- ANDA207193
- Sponsor
- Rite Aid Corporation
- NDC Codes
- 22
- Dosage Forms
- CAPSULE, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM
Indications and Usage
1 INDICATIONS AND USAGE Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. • juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use: • Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium. • Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. • Controlled studies do not extend beyond 6 months [see Use in Specific Populations ( 8.4 ), Clinical Studies ( 14 )]. Naproxen and esomeprazole magnesium delayed-release tablet is a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablet is indicated for relief of signs and symptoms of: • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. • juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers. ( 1 ) Limitations of Use: • Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium. ( 1 ) • Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. ( 1 ) • Controlled studies do not extend beyond 6 months. ( 1 )