1 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablets are a proton pump inhibitor (PPI) indicated for the following: Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) Maintenance of Healing of Erosive Esophagitis (1.2) Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome (1.3) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (EE). For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of EE and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome Pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.
aurobindo pharma limited
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied
PANTOPRAZOLE SODIUM Delayed-Release Tablets USP, 20 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with āIā and ā51ā with brown ink on one side and plain on other side. Bottles of 90 NDC 65862-559-90 Bottles of 1,000 NDC 65862-559-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-559-10
PANTOPRAZOLE SODIUM Delayed-Release Tablets USP, 40 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with āIā and ā52ā with brown ink on one side and plain on other side. Bottles of 90 NDC 65862-560-90 Bottles of 1,000 NDC 65862-560-99 Cartons of 100 (10 x 10) Unit-dose Tablets NDC 65862-560-10 Storage Store at 20Ā° to 25Ā°C (68Ā° to 77Ā°F). [See USP Controlled Room Temperature.]
2 years ago - Sunday, Feb 17, 2019, 7:10 pm
Pill with imprint I 52 is Yellow, Elliptical / Oval and has been identified as Pantoprazole Sodium Delayed-Release 40 mg. It is supplied by Aurobindo Pharma Limited. Pantoprazole is used in the treatment of barrett's esophagus; dumping syndrome; gerd; duodenal ulcer; erosive esophagitis (and more), and belongs to the drug class proton pump inhibitors. There is no proven risk in humans during pregnancy. Pantoprazole 40 mg is not a controlled substance under the Controlled Substances Act (CSA).
aurobindo pharma limited
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site