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Zantac 360

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
Zantac 360
Generic name
Famotidine
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Select Consumer Group LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
13
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, Film Coated
Route of administration
Oral
Presentations
17

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
206531
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 26, 2016
Sponsor
AUROBINDO PHARMA
Products on application
2
Submissions recorded
5
Products approved under application 206531.
Product Trade name Form Strength Ingredient Status TE Flags
206531-001 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —
206531-002 FAMOTIDINE TABLET FAMOTIDINE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 206531.
Type No. Action Status Date Review
Supplement 18 Labeling Approved August 25, 2022 Standard
Supplement 17 Manufacturing (CMC) Approved July 15, 2022 Unknown
Supplement 7 Labeling Approved September 11, 2019 Standard
Supplement 1 Labeling Approved September 11, 2019 Standard
Original application 1 Approved April 26, 2016 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260627). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260627

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

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 Acid reducer

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

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 1 0 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 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 us e 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 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 ■ your heartburn continues or worsens ■ you need to take this product for more than 14 days 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)

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 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 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 ■ your heartburn continues or worsens ■ you need to take this product for more than 14 days 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

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 us e 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

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 a doctor if ■ your heartburn continues or worsens ■ you need to take this product for more than 14 days

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 i ngredient (in each tablet ) Famotidine USP 10 mg

Active ingredient (in each tablet) 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
41167-0361-0 41167-0361 Chattem, Inc. 1 BLISTER PACK in 1 CARTON (41167-0361-0) / 8 TABLET, FILM COATED in 1 BLISTER PACK April 12, 2021
41167-0361-1 41167-0361 Chattem, Inc. 1 BLISTER PACK in 1 CARTON (41167-0361-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK April 12, 2021
41167-0361-2 41167-0361 Chattem, Inc. 1 BOTTLE in 1 CARTON (41167-0361-2) / 25 TABLET, FILM COATED in 1 BOTTLE April 12, 2021
41167-0361-4 41167-0361 Chattem, Inc. 1 BOTTLE in 1 CARTON (41167-0361-4) / 50 TABLET, FILM COATED in 1 BOTTLE April 12, 2021
41167-0361-6 41167-0361 Chattem, Inc. 1 BOTTLE in 1 CARTON (41167-0361-6) / 90 TABLET, FILM COATED in 1 BOTTLE April 12, 2021
41167-0361-8 41167-0361 Chattem, Inc. 1 BOTTLE in 1 CARTON (41167-0361-8) / 100 TABLET, FILM COATED in 1 BOTTLE April 12, 2021
41167-0361-9 41167-0361 Chattem, Inc. 2 BOTTLE in 1 CELLO PACK (41167-0361-9) / 70 TABLET, FILM COATED in 1 BOTTLE April 12, 2021
66715-9758-2 66715-9758 Lil' Drug Store Products, Inc 1 BLISTER PACK in 1 CARTON (66715-9758-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK January 5, 2023
66715-9758-5 66715-9758 Lil' Drug Store Products, Inc 1 BLISTER PACK in 1 CARTON (66715-9758-5) / 5 TABLET, FILM COATED in 1 BLISTER PACK September 20, 2021
67751-214-01 67751-214 Navajo Manufacturing Company Inc. 1 BLISTER PACK in 1 CARTON (67751-214-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK August 1, 2022
67751-214-02 67751-214 Navajo Manufacturing Company Inc. 2 BLISTER PACK in 1 CARTON (67751-214-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK August 1, 2022
85237-1926-1 85237-1926 Select Consumer Group LLC 1 BLISTER PACK in 1 CONTAINER (85237-1926-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK (85237-1926-0) June 4, 2025
85237-1926-2 85237-1926 Select Consumer Group LLC 2 BLISTER PACK in 1 CONTAINER (85237-1926-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK (85237-1926-0) June 4, 2025
41167-0361 41167-0361 Chattem, Inc. — April 12, 2021
66715-9758 66715-9758 Lil' Drug Store Products, Inc — September 20, 2021
67751-214 67751-214 Navajo Manufacturing Company Inc. — August 1, 2022
85237-1926 85237-1926 Select Consumer Group LLC — April 12, 2021

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.