OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Acid Reducer

Famotidine · Tablet

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
Acid Reducer
Generic name
Famotidine
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dr.Reddys Laboratories Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
6
Packages
14
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Esomeprazole Magnesium 20 mg/1 606726 View
Famotidine 10 mg/1 283641 View
Famotidine 20 mg/1 283641 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
20

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
Cytochrome P450 2C19 Inhibitors [MoA] MoA All 93 members
Histamine H2 Receptor Antagonists [MoA] MoA All 48 members
Histamine-2 Receptor Antagonist [EPC] EPC All 48 members
Proton Pump Inhibitor [EPC] EPC All 74 members
Proton Pump Inhibitors [MoA] MoA All 74 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
077367
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 25, 2006
Sponsor
DR REDDYS LABS LTD
Products on application
2
Submissions recorded
2
Products approved under application 077367.
Product Trade name Form Strength Ingredient Status TE Flags
077367-001 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —
077367-002 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 077367.
Type No. Action Status Date Review
Supplement 17 Labeling Approved November 8, 2019 Standard
Original application 1 Approved September 25, 2006 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260325). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260325 HUMAN OTC DRUG · 20260320 HUMAN OTC DRUG · 20250717 HUMAN OTC DRUG · 20241030

Indications and Usage

openFDA Drug Labeling

Use(s) 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

openFDA Drug Labeling

Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions For Famotidine 10 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. 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 do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor For Famotidine 20 mg: adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. 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 do not use more than 2 tablets in 24 hours children under 12 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy alert: Do not use if you are allergic to famotidine or other acid reducers 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 before use if you 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 disea Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor before use if your heartburn continues or worsens you need to take this product for more than 14 days If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Do Not Use

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

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

openFDA Drug Labeling

Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (trihydrate))

Adverse event reports

Source: openFDA FAERS
232,754
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: ESOMEPRAZOLE MAGNESIUM. 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
69168-443-09 69168-443 Allegiant Health 10 TABLET in 1 BLISTER PACK (69168-443-09) February 29, 2024
69168-443-32 69168-443 Allegiant Health 100 TABLET in 1 BOTTLE (69168-443-32) January 15, 2024
69168-443-50 69168-443 Allegiant Health 1 BOTTLE in 1 CARTON (69168-443-50) / 50 TABLET in 1 BOTTLE March 5, 2024
69168-443-52 69168-443 Allegiant Health 225 TABLET in 1 BOTTLE (69168-443-52) January 15, 2024
69168-443-99 69168-443 Allegiant Health 365 TABLET in 1 BOTTLE (69168-443-99) October 28, 2024
69168-445-32 69168-445 Allegiant Health 100 TABLET in 1 BOTTLE (69168-445-32) October 31, 2024
69168-445-52 69168-445 Allegiant Health 225 TABLET in 1 BOTTLE (69168-445-52) October 31, 2024
43598-824-18 43598-824 Dr.Reddys Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-824-18) / 180 TABLET in 1 BOTTLE September 1, 2020
43598-960-32 43598-960 Dr.Reddys Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-960-32) / 170 TABLET in 1 BOTTLE September 1, 2020
43598-960-65 43598-960 Dr.Reddys Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-960-65) / 65 TABLET in 1 BOTTLE September 1, 2020
43598-960-91 43598-960 Dr.Reddys Laboratories Inc. 1 BOTTLE in 1 CARTON (43598-960-91) / 90 TABLET in 1 BOTTLE October 7, 2021
85828-443-25 85828-443 Grocery Outlet 1 BOTTLE in 1 CARTON (85828-443-25) / 25 TABLET in 1 BOTTLE March 20, 2026
0363-9977-14 0363-9977 Walgreens 1 BOTTLE in 1 CARTON (0363-9977-14) / 14 TABLET in 1 BOTTLE November 4, 2022
0363-9977-42 0363-9977 Walgreens 3 BOTTLE, PLASTIC in 1 CARTON (0363-9977-42) / 14 TABLET in 1 BOTTLE, PLASTIC November 4, 2022
69168-443 69168-443 Allegiant Health — January 15, 2024
69168-445 69168-445 Allegiant Health — October 31, 2024
43598-824 43598-824 Dr.Reddys Laboratories Inc. — September 1, 2020
43598-960 43598-960 Dr.Reddys Laboratories Inc. — September 1, 2020
85828-443 85828-443 Grocery Outlet — March 20, 2026
0363-9977 0363-9977 Walgreens — November 4, 2022

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 · 11 sections on this page.