FDA label
What is famotidine used for?
The FDA-approved uses of famotidine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy.”
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Famotidine, tablet, film coated
Indications and Usage, quoted from the label by Redpharm Drug (ANDA217400). Cross-references to other label sections are left out.
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy.
Source: DailyMed label, set id 44f3f63d-4522-91e4-e063-6394a90a6d1b, version 1, effective December 2, 2025. NDC 67296-2186, one of 100 listings for this product.
Famotidine, tablet
Indications and Usage, quoted from the label by NCS HealthCare of KY, LLC dba Vangard Labs (ANDA078916). Cross-references to other label sections are left out.
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
- active duodenal ulcer (DU).
- active gastric ulcer (GU).
- symptomatic nonerosive gastroesophageal reflux disease (GERD).
- erosive esophagitis due to GERD, diagnosed by biopsy.
Famotidine tablets are indicated in adults for the:
- treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
- reduction of the risk of duodenal ulcer recurrence.
Source: DailyMed label, set id 59b17677-d805-4d9e-9c64-96385ae47bff, version 1, effective January 27, 2025. NDC 0615-8558, one of 42 listings for this product.
Famotidine, powder, for suspension
Indications and Usage, quoted from the label by Lannett Company, Inc. (ANDA217982). Cross-references to other label sections are left out.
Famotidine for Oral Suspension is indicated in adults for the treatment of:
- active duodenal ulcer (DU).
- active gastric ulcer (GU).
- symptomatic nonerosive gastroesophageal reflux disease (GERD).
- erosive esophagitis due to GERD, diagnosed by biopsy.
- treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
- reduction of the risk of DU recurrence.
Famotidine for Oral Suspension is indicated in pediatric patients 1 year of age and older for the treatment of:
- peptic ulcer disease.
- GERD with or without esophagitis and ulcerations.
Famotidine for Oral Suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:
- GERD.
Source: DailyMed label, set id 7e0da8be-b001-400e-99d1-37f335b1d7b3, version 6, effective May 2, 2025. NDC 0527-5190, one of 21 listings for this product.
Questions
What is famotidine used for?
The FDA label says: “Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy.”
What drug class is famotidine?
FDA lists famotidine in the Histamine-2 Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.