omeprazole and sodium bicarbonate
omeprazole and sodium bicarbonate is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including Konvomep, ZEGERID. Available dosage forms: kit, capsule, powder, for suspension.
Drug Details
- Generic Name
- omeprazole and sodium bicarbonate
- Brand Names
- Konvomep, ZEGERID
- Application Number
- NDA213593
- Sponsor
- Azurity Pharmaceuticals, Inc.
- NDC Codes
- 5
- Dosage Forms
- KIT, CAPSULE, POWDER, FOR SUSPENSION
- Routes
- ORAL
- Active Ingredients
- OMEPRAZOLE, SODIUM BICARBONATE
Indications and Usage
1 INDICATIONS AND USAGE Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the : short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate capsules may be considered. maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months. Omeprazole and Sodium Bicarbonate capsules are a proton pump inhibitor (PPI). Omeprazole and Sodium Bicarbonate capsules are indicated in adults for: Treatment of active duodenal ulcer ( 1 ) Treatment of active benign gastric ulcer ( 1 ) Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) ( 1 ) Maintenance of healing of EE ( 1 )