pantoprazole sodium
pantoprazole sodium is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including pantoprazole sodium, Protonix I.V., Pantoprazole Sodium. Available dosage forms: tablet, delayed release, injection, powder, for solution, powder.
Drug Details
- Generic Name
- pantoprazole sodium
- Brand Names
- pantoprazole sodium, Protonix I.V., Pantoprazole Sodium
- Application Number
- ANDA217282
- Sponsor
- Granules Pharmaceuticals Inc.
- NDC Codes
- 14
- Dosage Forms
- TABLET, DELAYED RELEASE, INJECTION, POWDER, FOR SOLUTION, POWDER
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- PANTOPRAZOLE SODIUM
Indications and Usage
1 INDICATIONS AND USAGE Pantoprazole Sodium for Injection is indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults. Limitations of Use The safety and effectiveness of Pantoprazole Sodium for Injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. Pediatric use information is approved for Pfizer Inc.'s PROTONIX® I.V. (pantoprazole sodium) for Injection. However, due to Pfizer Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Pantoprazole Sodium for Injection is a proton pump inhibitor (PPI) indicated for treatment of: gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. ( 1 ) pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. ( 1 ) Limitations of Use The safety and effectiveness of pantoprazole sodium for injection for the treatment of upper gastrointestinal bleeding have not been established in adult or pediatric patients. ( 1 )