Is Famotidine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Famotidine, including FAMODAR (20 mg, Film-coated tablet, SAR 38.70); FAMODAR (40 mg, Film-coated tablet, SAR 25.75); Famodine (10 mg/ml, concentrate for solution for injection, SAR 64.25); Famotidine Amarox (40 mg, Tablet, SAR 77.25); Famotidine Amarox (20 mg, Tablet, SAR 38.60).

Is Famotidine approved by the US FDA?

Drugs@FDA lists 102 application product lines for Famotidine, including PEPCID AC (Over-the-counter); PEPCID AC (Over-the-counter); FAMOTIDINE (Prescription); FAMOTIDINE PRESERVATIVE FREE (Prescription); FAMOTIDINE (Prescription).

Are there safety signals or safety updates for Famotidine?

US FDA: 6 entries (latest 2024-11-21).

Active substance

Famotidine

SFDA 21
US FDA 102
Health Canada 19
US price lines 9
NHS prices 2
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FAMODAR	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 38.70	Generic · Prescription	DAR ALDAWA	Valid
FAMODAR	40 mg	Film-coated tablet · Oral use	10 Blister	SAR 25.75	Generic · Prescription	DAR ALDAWA	Valid
Famodine	10 mg/ml	concentrate for solution for injection · Intravenous use	5 Ampoule	SAR 64.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Famotidine Amarox	40 mg	Tablet · Oral use	30 Blister	SAR 77.25	Generic · Prescription	Saudi Amarox	Valid
Famotidine Amarox	20 mg	Tablet · Oral use	30 Blister	SAR 38.60	Generic · Prescription	Saudi Amarox	Valid
Famotidine Amarox	10 mg	Tablet · Oral use	30 Blister	SAR 19.30	Generic · Prescription	Saudi Amarox	Valid
Famotidine Amarox	8 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 1270.50	Generic · Prescription	Saudi Amarox	Valid
Famotidine Amarox	10 mg/ml	Injection · Intravenous use	1 Vial	SAR 12.20	Generic · Prescription	Saudi Amarox	Valid
Famotidine for oral suspension	40-5 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 1649.85	Generic · Prescription	Navinta LLC	Valid
famodar	10 mg	Film-coated tablet · Oral use	10 Blister	SAR 6.45	Generic · OTC	DAR Al DAWA	Valid
FAMOCID 10MG F.C TAB	10 mg	Film-coated tablet · Oral use	10 Blister	SAR 16.45	Generic · OTC	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
FAMOCID 20 MG F.C TAB	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 72.60	Generic · OTC	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
FAMOCID 40 MG F.C. TAB	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 132.50	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
FAMOCID 40 MG F.C. TAB	40 mg	Film-coated tablet · Oral use	10 Blister	SAR 50.70	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
FAMOGEN	10 mg	Film-coated tablet · Oral use	10 Blister	SAR 14.80	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
FAMOGEN	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 65.30	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
FAMOGEN	40 mg	Film-coated tablet · Oral use	10 Blister	SAR 45.65	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
FAMOGEN	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 119.20	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
PEPCIDIN 20MG TAB	20 mg	Tablet · Oral use	30 Blister	SAR 92.90	NCE · OTC	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
PEPCIDIN 40MG TAB	40 mg	Tablet · Oral use	30 Blister	SAR 169.65	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed
PEPCIDIN 40MG TAB	40 mg	Tablet · Oral use	10 Blister	SAR 64.45	NCE · Prescription	MERCK SHARP & DOHME	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANAPHYLACTIC SHOCK; DYSPEPSIA; GASTROESOPHAGEAL REFLUX DISEASE (GERD); PEPTIC ULCER; URTICARIA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PEPCID AC	10MG; 20MG	tablet · oral	KENVUE BRANDS	Over-the-counter	28 Apr 1995
PEPCID AC	20MG	tablet, chewable · oral	KENVUE BRANDS	Over-the-counter	24 Sep 1998
FAMOTIDINE	20MG; 40MG	tablet · oral	MANKIND PHARMA	Prescription	16 Apr 2001
FAMOTIDINE PRESERVATIVE FREE	10MG/ML	injectable · injection	HIKMA PHARMS	Prescription	16 Apr 2001
FAMOTIDINE	10MG/ML	injectable · injection	HIKMA PHARMS	Prescription	16 Apr 2001
FAMOTIDINE	20MG; 40MG	tablet · oral	IVAX SUB TEVA PHARMS	Prescription	16 Apr 2001
FAMOTIDINE PRESERVATIVE FREE	10MG/ML	injectable · injection	SAGENT	Prescription	16 Apr 2001
FAMOTIDINE	10MG/ML	injectable · injection	SAGENT	Prescription	16 Apr 2001
FAMOTIDINE	10MG/ML	injectable · injection	SAGENT	Prescription	16 Apr 2001
FAMOTIDINE	20MG; 40MG	tablet · oral	RISING	Prescription	16 Apr 2001
FAMOTIDINE	10MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	16 Apr 2001
FAMOTIDINE	20MG; 40MG	tablet · oral	DR REDDYS LABS LTD	Prescription	16 Apr 2001
FAMOTIDINE	20MG; 40MG	tablet · oral	CHARTWELL RX	Prescription	16 Apr 2001
FAMOTIDINE	20MG; 40MG	tablet · oral	CARLSBAD	Prescription	16 Apr 2001
FAMOTIDINE PRESERVATIVE FREE	10MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	16 Apr 2001
FAMOTIDINE PRESERVATIVE FREE	10MG/ML	injectable · injection	SAGENT	Prescription	17 Apr 2001
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	0.4MG/ML	injectable · injection	BAXTER HLTHCARE	Prescription	10 May 2001
FAMOTIDINE	10MG	tablet · oral	P AND L	Over-the-counter	26 Jul 2001
FAMOTIDINE	10MG	tablet · oral	GLENMARK PHARMS	Over-the-counter	7 Mar 2005
FAMOTIDINE	10MG	tablet · oral	PERRIGO	Over-the-counter	18 Mar 2005
FAMOTIDINE	20MG	tablet · oral	PERRIGO R AND D	Over-the-counter	25 Sep 2006
FAMOTIDINE	20MG; 10MG	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	25 Sep 2006
FAMOTIDINE	10MG/ML	injectable · injection	MYLAN LABS LTD	Prescription	25 Jun 2008
FAMOTIDINE PRESERVATIVE FREE	10MG/ML	injectable · injection	MYLAN LABS LTD	Prescription	25 Jun 2008
FAMOTIDINE	20MG; 40MG	tablet · oral	ALEMBIC PHARMS LTD	Prescription	22 May 2009

77 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACID CONTROLLER MAXIMUM STRENGTH	02538350	20 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-FAMOTIDINE	02509970	20 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-FAMOTIDINE	02509989	40 MG	TABLET · ORAL	ANGITA PHARMA INC.
FAMOTIDINE	02351102	20 MG	TABLET · ORAL	SANIS HEALTH INC
FAMOTIDINE	02351110	40 MG	TABLET · ORAL	SANIS HEALTH INC
FAMOTIDINE	02549107	20 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
FAMOTIDINE	02549115	40 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
FAMOTIDINE OMEGA -(WITH PRESERVATIVE,BENZYL ALCOHOL)	02247745	10 MG / ML	SOLUTION · INTRAVENOUS	OMEGA LABORATORIES LIMITED
FAMOTIDINE OMEGA -(WITHOUT PRESERVATIVE)	02247735	10 MG / ML	SOLUTION · INTRAVENOUS	OMEGA LABORATORIES LIMITED
JAMP FAMOTIDINE	02507749	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP FAMOTIDINE	02507757	40 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MAXIMUM STRENGTH PEPCID AC	02273357	20 MG	TABLET · ORAL	KENVUE CANADA INC.
MINT-FAMOTIDINE	02538628	20 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-FAMOTIDINE	02538636	40 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PEPCID AC	02185938	10 MG	TABLET · ORAL	KENVUE CANADA INC.
RIVA-FAMOTIDINE	02562332	20 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
RIVA-FAMOTIDINE	02562340	40 MG	TABLET · ORAL	LABORATOIRE RIVA INC.
TEVA-FAMOTIDINE	02022133	20 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-FAMOTIDINE	02022141	40 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FAMOTIDINE 10 MG TABLET	$0.0947	per EA	23 Sep 2026
US NADAC	FAMOTIDINE 20 MG TABLET	$0.02886	per EA	23 Sep 2026
US NADAC	FAMOTIDINE 20 MG TABLET	$0.13819	per EA	23 Sep 2026
US NADAC	FAMOTIDINE 20 MG/2 ML VIAL	$0.30272	per ML	23 Sep 2026
US NADAC	FAMOTIDINE 40 MG TABLET	$0.04834	per EA	23 Sep 2026
US NADAC	FAMOTIDINE 40 MG/5 ML SUSP	$0.4942	per ML	22 Jul 2026
US NADAC	FAMOTIDINE 40 MG/5 ML SUSP	$0.13046	per ML	30 Sep 2026
US NADAC	FAMOTIDINE 40 MG/5 ML SUSP	$0.07341	per ML	23 Sep 2026
US NADAC	QC FAMOTIDINE 20 MG TABLET	$0.13819	per EA	23 Sep 2026
NHS Drug Tariff	Famotidine 20mg tablets	£1.48	28 tablet	1 Oct 2026
NHS Drug Tariff	Famotidine 40mg tablets	£2.18	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 21 Nov 2024 DUEXIS — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 29 Oct 2019 PEPCID AC — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 15 Aug 2019 PEPCID — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 9 Apr 2019 PEPCID AC — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 9 Apr 2019 PEPCID COMPLETE — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 11 Nov 2018 PEPCID — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for famotidine →

Combinations containing Famotidine

Calcium carbonate + famotidine + magnesium hydroxide

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.