Is Ranitidine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Ranitidine.

Is Ranitidine approved by the US FDA?

Drugs@FDA lists 88 application product lines for Ranitidine, including RANITIDINE HYDROCHLORIDE (Prescription); RANITIDINE HYDROCHLORIDE (Prescription); RANITIDINE HYDROCHLORIDE (Over-the-counter); RANITIDINE HYDROCHLORIDE (Prescription); RANITIDINE HYDROCHLORIDE (Prescription).

Is Ranitidine on the WHO Model List of Essential Medicines?

Yes — 17.1. Antiulcer medicines (core list): Peptic ulcer, site unspecified; Gastro-oesophageal reflux disease.

Are there safety signals or safety updates for Ranitidine?

US FDA: 2 entries (latest 2019-04-04).

Active substance

Ranitidine

SFDA 58
US FDA 88
Health Canada 5
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ACICARE	75 mg	Film-coated tablet · Oral use	20 Blister	SAR 15.10	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
ACICARE	150 mg	Tablet · Oral use	20 Blister	SAR 32.20	Generic · OTC	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
ACICARE	300 mg	Tablet · Oral use	10 Blister	SAR 37.40	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
ACICARE	300 mg	Tablet · Oral use	20 Blister	SAR 65.80	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed
ANI 150MG/5.4GM EFFERVESCENT GRANULES	150 mg	Effervescent granules · Oral use	6 Sachet	SAR 6.85	Generic · Prescription	PHARCO PHARMACEUTICAL	Suspended · Not Marketed
ANTAGONIN 150MG TAB	150 mg	Tablet · Oral use	20 Blister	SAR 39.80	Generic · OTC	APM	Withdrawn by MAH · Not Marketed
ANTAGONIN 300MG TAB	300 mg	Tablet · Oral use	10 Blister	SAR 27.70	Generic · Prescription	APM	Withdrawn by MAH · Not Marketed
APO-RANITIDINE 150MG F.C.TAB.	150 mg	Tablet · Oral use	20 Blister	SAR 18.15	NCE · OTC	APOTEX	Suspended · Not Marketed
APO-RANITIDINE 150MG F.C.TAB.	150 mg	Tablet · Oral use	60 Blister	SAR 96.15	NCE · OTC	APOTEX	Withdrawn by MAH · Not Marketed
APO-RANITIDINE 300MG F.C.TAB.	300 mg	Tablet · Oral use	30 Blister	SAR 39.25	NCE · Prescription	APOTEX	Withdrawn by MAH · Not Marketed
APO-RANITIDINE 300MG F.C.TAB.	300 mg	Tablet · Oral use	10 Blister	SAR 13.10	NCE · Prescription	APOTEX	Withdrawn by MAH · Not Marketed
GLOTAC 150 MG FILM COATED TABLETS	150 mg	Film-coated tablet · Oral use	20 Blister	SAR 23.50	Generic · Prescription	GLOBAL PHARMA	Suspended · Not Marketed
GLOTAC 300 MG FILM COATED TABLETS	300 mg	Film-coated tablet · Oral use	10 Blister	SAR 26.25	Generic · Prescription	GLOBAL PHARMA	Withdrawn by MAH · Not Marketed
NADINE 150 MG FILM COATED TABLETS	150 mg	Film-coated tablet · Oral use	20 Blister	SAR 9.30	Generic · Prescription	Pharma International Co.	Suspended · Not Marketed
NADINE 300 MG FILM COATED TABLETS	300 mg	Film-coated tablet · Oral use	10 Blister	SAR 14.00	Generic · Prescription	Pharma International Co.	Suspended · Not Marketed
NAVIDINE 150MG TABLET	150 mg	Tablet · Oral use	30 Blister	SAR 11.55	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Suspended · Not Marketed
NOVO-RANIDINE 150MG TABLET	150 mg	Tablet · Oral use	20 Blister	SAR 36.65	Generic · OTC	NOVOPHARM	Withdrawn by MAH · Not Marketed
NOVO-RANIDINE 150MG TABLET	150 mg	Tablet · Oral use	60 Blister	SAR 106.05	Generic · OTC	NOVOPHARM	Withdrawn by MAH · Not Marketed
NOVO-RANIDINE 300MG TAB	300 mg	Tablet · Oral use	30 Blister	SAR 88.75	Generic · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed
NOVO-RANIDINE 300MG TAB	300 mg	Tablet · Oral use	12 Blister	SAR 44.00	Generic · Prescription	NOVOPHARM	Withdrawn by MAH · Not Marketed
PEPTAC 150 MG FILM COATED TABLETS	150 mg	Film-coated tablet · Oral use	20 Blister	SAR 10.35	Generic · OTC	Ram Pharmaceutical Industries	Suspended · Not Marketed
PEPTAC 300 MG FILM COATED TABLETS	300 mg	Film-coated tablet · Oral use	10 Blister	SAR 10.35	Generic · Prescription	Ram Pharmaceutical Industries	Suspended · Not Marketed
RANACID 75MG F.C.TAB	75 mg	Tablet · Oral use	12 Blister	SAR 16.35	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Withdrawn by MAH · Not Marketed
RANACID 75MG\5ML SYRUP	15 mg/ml	Syrup · Oral use	1 Bottle	SAR 34.20	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Invalid · Not Marketed
RANID 150MG F.C.TAB.	150 mg	Film-coated tablet · Oral use	20 Blister	SAR 44.25	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Suspended · Not Marketed

33 more — full table

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

Product	Strength	Form · route	Applicant	Status	First approved
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	SANDOZ	Prescription	29 Aug 1997
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	capsule · oral	SANDOZ	Prescription	22 Oct 1997
RANITIDINE HYDROCHLORIDE	EQ 75MG BASE	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	28 Mar 2000
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	capsule · oral	DR REDDYS LABS LTD	Prescription	29 Nov 2000
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	DR REDDYS LABS INC	Prescription	27 Jul 2005
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	31 Aug 2007
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	VKT PHARMA	Prescription	31 Jan 2019
ZANTAC 150	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	GLAXO GRP LTD	Discontinued	9 Jun 1983
ZANTAC 300	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	GLAXO GRP LTD	Discontinued	9 Jun 1983
ZANTAC	EQ 25MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	PAI HOLDINGS PHARM	Discontinued	19 Oct 1984
ZANTAC IN PLASTIC CONTAINER	EQ 50MG BASE/100ML; EQ 1MG BASE/ML	injectable · injection	PAI HOLDINGS PHARM	Discontinued	17 Dec 1986
ZANTAC	EQ 15MG BASE/ML	syrup · oral	GLAXO GRP LTD	Discontinued	30 Dec 1988
ZANTAC 150	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	GLAXOSMITHKLINE	Discontinued	8 Mar 1994
ZANTAC 300	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	GLAXOSMITHKLINE	Discontinued	8 Mar 1994
ZANTAC 150	EQ 150MG BASE	tablet, effervescent · oral	GLAXO GRP LTD	Discontinued	31 Mar 1994
ZANTAC 150	EQ 150MG BASE/PACKET	granule, effervescent · oral	GLAXO GRP LTD	Discontinued	31 Mar 1994
ZANTAC 25	EQ 25MG BASE	tablet, effervescent · oral	GLAXO GRP LTD	Discontinued	31 Mar 1994
ZANTAC 75	EQ 75MG BASE	tablet · oral	CHATTEM SANOFI	Discontinued	19 Dec 1995
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	ANI PHARMS	Discontinued	31 Jul 1997
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	MYLAN	Discontinued	22 Aug 1997
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	BOEHRINGER INGELHEIM	Discontinued	29 Aug 1997
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	APOTEX	Discontinued	12 Sep 1997
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	WATSON LABS	Discontinued	20 Oct 1997
RANITIDINE HYDROCHLORIDE	EQ 150MG BASE; EQ 300MG BASE	tablet · oral	RANBAXY	Discontinued	30 Jan 1998
ZANTAC 75	EQ 75MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, effervescent · oral	CHATTEM SANOFI	Discontinued	26 Feb 1998

63 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MAR-RANITIDINE	02443708	150 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-RANITIDINE	02443716	300 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAXIMUM STRENGTH ACID REDUCER WITHOUT PRESCRIPTION	02293471	150 MG	TABLET · ORAL	PHARMASCIENCE INC
MINT-RANITIDINE	02526379	150 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-RANITIDINE	02526387	300 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC

WHO WHO Model List of Essential Medicines (2025)

17.1. Antiulcer medicines · core
Peptic ulcer, site unspecified; Gastro-oesophageal reflux disease
Oral > Liquid: 75 mg per 5 mL (as hydrochloride) | Oral > Solid: 150 mg (as hydrochloride) | Parenteral > General injections > unspecified: 25 mg per mL in 2 mL ampoule (as hydrochloride)

Safety signals and safety-related labeling changes

US FDA 4 Apr 2019 ZANTAC 150 — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 4 Apr 2019 ZANTAC 75 — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for ranitidine →

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.