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acid controller

Famotidine · Tablet, Film Coated

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 controller
Generic name
Famotidine
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
H E B
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
11
Packages
21
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
Cimetidine 200 mg/1 197505 View
Famotidine 10 mg/1 283641 View
Famotidine 20 mg/1 283641 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
32

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
077351
Application type
ANDA · Abbreviated New Drug Application
Approval date
September 25, 2006
Sponsor
PERRIGO R AND D
Products on application
1
Submissions recorded
4
Products approved under application 077351.
Product Trade name Form Strength Ingredient Status TE Flags
077351-001 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 077351.
Type No. Action Status Date Review
Supplement 28 Manufacturing (CMC) Approved August 18, 2021 Standard
Supplement 23 Labeling Approved February 18, 2021 Standard
Supplement 18 Manufacturing (CMC) Approved April 26, 2016 Unknown
Original application 1 Approved September 25, 2006 —

Review documents

  • 0 · Original application · September 27, 2006

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260511). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260511 HUMAN OTC DRUG · 20260303

Indications and Usage

openFDA Drug Labeling

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 foods and beverages

Purpose Acid reducer

Dosage and Administration

openFDA Drug Labeling

Directions • 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

Warnings Allergy alert: Do not use if you are allergic to cimetidine 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 have • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • 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 • kidney disease • liver disease 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 if • you need to take this product for more than 14 days • stomach pain continues • your heartburn continues or worsens If pregnant or breast-feeding, 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 right away (1-800-222-1222).

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 you have • frequent chest pain • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • 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 • kidney disease • liver disease

Stop use and ask a doctor if • you need to take this product for more than 14 days • stomach pain continues • your heartburn continues or worsens

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Cimetidine 200 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
59779-141-39 59779-141 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-141-39) / 30 TABLET, FILM COATED in 1 BOTTLE September 24, 2015
59779-141-75 59779-141 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-141-75) / 90 TABLET, FILM COATED in 1 BOTTLE October 17, 2009
59779-194-63 59779-194 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-194-63) / 25 TABLET, FILM COATED in 1 BOTTLE September 14, 2015
59779-194-71 59779-194 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-194-71) / 50 TABLET, FILM COATED in 1 BOTTLE September 28, 2006
59779-194-78 59779-194 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-194-78) / 100 TABLET, FILM COATED in 1 BOTTLE May 23, 2007
59779-194-98 59779-194 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-194-98) / 75 TABLET, FILM COATED in 1 BOTTLE April 1, 2025
51316-739-76 51316-739 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 BOTTLE in 1 CARTON (51316-739-76) / 120 TABLET, FILM COATED in 1 BOTTLE April 8, 2026
37808-042-63 37808-042 H E B 1 BOTTLE in 1 CARTON (37808-042-63) / 25 TABLET, FILM COATED in 1 BOTTLE January 27, 2020
37808-042-71 37808-042 H E B 1 BOTTLE in 1 CARTON (37808-042-71) / 50 TABLET, FILM COATED in 1 BOTTLE May 31, 2020
37808-042-82 37808-042 H E B 1 BOTTLE in 1 CARTON (37808-042-82) / 200 TABLET, FILM COATED in 1 BOTTLE September 14, 2016
37808-301-65 37808-301 H E B 30 BLISTER PACK in 1 CARTON (37808-301-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK October 23, 2015
37808-301-72 37808-301 H E B 1 BOTTLE in 1 CARTON (37808-301-72) / 60 TABLET, FILM COATED in 1 BOTTLE October 23, 2015
59640-001-63 59640-001 H E B 1 BOTTLE in 1 CARTON (59640-001-63) / 25 TABLET, FILM COATED in 1 BOTTLE June 6, 2022
21130-521-82 21130-521 Safeway 1 BOTTLE in 1 CARTON (21130-521-82) / 200 TABLET, FILM COATED in 1 BOTTLE June 27, 2025
21130-771-75 21130-771 Safeway 1 BOTTLE in 1 CARTON (21130-771-75) / 90 TABLET, FILM COATED in 1 BOTTLE August 13, 2025
0363-0141-39 0363-0141 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0141-39) / 30 TABLET, FILM COATED in 1 BOTTLE January 16, 2026
0363-0141-48 0363-0141 Walgreen Company 2 BOTTLE in 1 CARTON (0363-0141-48) / 90 TABLET, FILM COATED in 1 BOTTLE December 12, 2025
0363-0141-75 0363-0141 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0141-75) / 90 TABLET, FILM COATED in 1 BOTTLE August 28, 2009
0363-0701-82 0363-0701 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0701-82) / 200 TABLET, FILM COATED in 1 BOTTLE May 8, 2019
0363-0701-98 0363-0701 Walgreen Company 1 BOTTLE in 1 CARTON (0363-0701-98) / 75 TABLET, FILM COATED in 1 BOTTLE March 13, 2026
0363-1203-71 0363-1203 Walgreen Company 1 BOTTLE in 1 CARTON (0363-1203-71) / 50 TABLET, FILM COATED in 1 BOTTLE April 7, 2022
59779-141 59779-141 CVS Pharmacy — October 17, 2009
59779-194 59779-194 CVS Pharmacy — September 28, 2006
51316-739 51316-739 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — April 8, 2026
37808-042 37808-042 H E B — September 14, 2016
37808-301 37808-301 H E B — October 23, 2015
59640-001 59640-001 H E B — June 6, 2022
21130-521 21130-521 Safeway — June 27, 2025
21130-771 21130-771 Safeway — August 13, 2025
0363-0141 0363-0141 Walgreen Company — August 28, 2009
0363-0701 0363-0701 Walgreen Company — September 26, 2006
0363-1203 0363-1203 Walgreen Company — April 7, 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 · 10 sections on this page.