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Famotidine 20 mg

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Famotidine 20 mg
Generic name
Famotidine 20 mg
Dosage form
Tablet, Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
MARKSANS PHARMA LIMITED
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
8
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Famotidine 20 mg/1 283641 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
10

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Histamine H2 Receptor Antagonists [MoA] MoA All 48 members
Histamine-2 Receptor Antagonist [EPC] EPC All 48 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
217543
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 8, 2023
Sponsor
MARKSANS PHARMA
Products on application
2
Submissions recorded
1
Products approved under application 217543.
Product Trade name Form Strength Ingredient Status TE Flags
217543-001 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —
217543-002 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 217543.
Type No. Action Status Date Review
Original application 1 Approved March 8, 2023 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250506). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250506 HUMAN OTC DRUG · 20240930

Indications and Usage

openFDA Drug Labeling

USE(S) Uses •relieves heartburn associated with acid indigestion and sour stomach •prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

PURPOSE Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions For 10 mg: • adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn o do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor For 20 mg: • adults and children 12 years and over: o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. o to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn o do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor

WARNINGS Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

DO NOT USE Do not use •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. •with other acid reducers

Ask a Doctor

openFDA Drug Labeling

ASK A DOCTOR BEFORE USE IF Ask a doctor before use if you have •had heartburn over 3 months. This may be a sign of a more serious condition. •heartburn with lightheadedness, sweating, or dizziness •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness •frequent chest pain •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain •kidney disease

STOP USE AND ASK DOCTOR IF Stop use and ask a doctor if •your heartburn continues or worsens •you need to take this product for more than 14 days

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) For 10 mg: Famotidine USP 10 mg For 20 mg: Famotidine USP 20 mg

Adverse event reports

Source: openFDA FAERS
118,947
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: FAMOTIDINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
25000-087-03 25000-087 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-087-03) / 30 TABLET, COATED in 1 BOTTLE March 10, 2023
25000-087-05 25000-087 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-087-05) / 50 TABLET, COATED in 1 BOTTLE April 24, 2024
25000-087-08 25000-087 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-087-08) / 100 TABLET, COATED in 1 BOTTLE March 10, 2023
25000-087-36 25000-087 MARKSANS PHARMA LIMITED 3 BLISTER PACK in 1 CARTON (25000-087-36) / 10 TABLET, COATED in 1 BLISTER PACK March 10, 2023
25000-087-82 25000-087 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-087-82) / 200 TABLET, COATED in 1 BOTTLE February 15, 2024
25000-124-68 25000-124 MARKSANS PHARMA LIMITED 300 TABLET, COATED in 1 BOTTLE (25000-124-68) May 23, 2025
25000-124-84 25000-124 MARKSANS PHARMA LIMITED 1 BOTTLE in 1 CARTON (25000-124-84) / 25 TABLET, COATED in 1 BOTTLE May 23, 2025
25000-124-94 25000-124 MARKSANS PHARMA LIMITED 5 BLISTER PACK in 1 CARTON (25000-124-94) / 5 TABLET, COATED in 1 BLISTER PACK May 23, 2025
25000-087 25000-087 MARKSANS PHARMA LIMITED — March 10, 2023
25000-124 25000-124 MARKSANS PHARMA LIMITED — May 23, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.