Overview

Ranitidine is a commonly used drug, classified as a histamine H2-receptor antagonist, and belongs to the same drug class as cimetidine and famotidine. This drug helps to prevent and treat gastric-acid associated conditions, including ulcers, because of its ability to decrease gastric acid secretion. Ranitidine is often referred to as Zantac, and is available in various forms, including tablet, injection, and effervescent tablet preparations. The prevalence of GERD is thought to be 10-20% in western countries. Ranitidine has proven to be an effective treatment for relieving uncomfortable symptoms of gastric acid associated conditions and is therefore widely used in GERD and other gastric-acid related conditions.

Indication

This drug is used alone or with concomitant antacids for the following conditions: short-term treatment of active duodenal ulcer, treating gastric acid hypersecretion due to Zollinger-Ellison syndrome, systemic mastocytosis, and other conditions that may pathologically raise gastric acid levels. It also used in the short term treatment of active benign gastric ulcers and maintenance therapy of gastric ulcers at a reduced dose. In addition to the above, ranitidine can be used for the treatment of GERD symptoms, treatment of erosive esophagitis (endoscopically diagnosed) and the maintenance of gastric or duodenal ulcer healing.

Associated Conditions

Acid Aspiration Syndrome
Ankylosing Spondylitis (AS)
Duodenal Ulcer
Erosive Esophagitis
Gastric Ulcer
Gastric hypersecretion
Gastro-esophageal Reflux Disease (GERD)
Healing
Heartburn
Osteoarthritis (OA)
Peptic Ulcer Disease
Rheumatoid Arthritis
Stress Ulcers
Zollinger-Ellison Syndrome
Active Duodenal ulcer
Benign gastric ulcer healing
Benign gastric ulcers
Duodenal ulcer healing
Post-operative peptic ulcer
Recurrent hemorrhage from bleeding ulcers

Research Report

Published: Aug 12, 2025

Ranitidine (DB00863): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Regulatory Withdrawal due to N-Nitrosodimethylamine (NDMA) Contamination

Section 1: Chemical Profile and Physicochemical Properties

[Ranitidine is a small molecule drug that, for decades, was a cornerstone in the management of acid-related gastrointestinal disorders. Its journey from a celebrated therapeutic agent to a product withdrawn from global markets is rooted in its fundamental chemical nature. A thorough understanding of its chemical identity, structure, and physicochemical properties is therefore essential, as these characteristics not only defined its therapeutic efficacy but also contained the latent potential for its ultimate failure. This section provides a definitive chemical and physical fingerprint of ranitidine, establishing the foundation for the subsequent analysis of its pharmacology, clinical use, and regulatory history.]

1.1 Nomenclature and Identifiers

[To unambiguously identify the compound across scientific literature, regulatory documents, and clinical practice, a comprehensive list of its names and identifiers is crucial. Ranitidine was marketed globally under a multitude of brand names and is cataloged in numerous chemical and pharmacological databases.]

[The most widely recognized brand name for ranitidine was Zantac.][1][ Other brand names used in the United States and internationally included Acid Reducer, Taladine, Berkley and Jensen Acid Reducer Maximum Strength, and Deprizine.][4][ Synonyms encountered in various markets include Ratic, Raticina, RND, Sampep, Taural, Zantic, Azantac, Raniplex, and Ranidil.][5][ The international nonproprietary name (INN) system also provides standardized names in different languages, such as]

Ranitidin[ (German), ]Ranitidina[ (Spanish), and ]Ranitidinum[ (Latin).][1]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants	2022/04/21	NCT05338502	Phase 1	Completed	Eli Lilly and Company
A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor	2022/03/28	NCT05298683	Phase 2	Not yet recruiting	Hellenic Society of Hematology
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel	2021/04/28	NCT04862585	Phase 2	Completed	Ohio State University Comprehensive Cancer Center
Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies	2020/12/23	NCT04681105	Phase 1	Active, not recruiting	City of Hope Medical Center
Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration	2020/05/21	NCT04397445	Phase 1	Completed	Food and Drug Administration (FDA)
Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation	2020/03/04	NCT04294459	Phase 1	Terminated	Sanofi
A Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Participants	2018/03/19	NCT03468777	Phase 1	Terminated	Janssen Research & Development, LLC
A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT	2017/12/11	NCT03368664	Phase 3	Active, not recruiting	Genzyme, a Sanofi Company
Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity	2017/05/09	NCT03145012	Phase 4	Completed	Nova Scotia Health Authority
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery	2017/05/04	NCT03140033	Phase 2	UNKNOWN	Ain Shams Maternity Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
RANITIDINE	STAT Rx USA LLC	16590-381	ORAL	300 mg in 1 1	10/3/2012
Ranitidine Immediate release	Aphena Pharma Solutions - Tennessee, LLC	71610-378	ORAL	150 mg in 1 1	1/15/2020
Ranitidine	Bryant Ranch Prepack	71335-1621	ORAL	300 mg in 1 1	12/7/2018
RANITIDINE	WOCKHARDT USA LLC	64679-694	ORAL	15 mg in 1 mL	1/19/2011
RANITIDINE	Northwind Pharmaceuticals, LLC	51655-681	ORAL	150 mg in 1 1	11/10/2014
Ranitidine	RxChange Co.	33358-316	ORAL	150 mg in 1 1	11/25/2014
Ranitidine	Contract Pharmacy Services-PA	67046-648	ORAL	150 mg in 1 1	9/26/2017
Ranitidine	NuCare Pharmaceuticals,Inc.	68071-3162	ORAL	150 mg in 1 1	2/11/2021
Ranitidine Hydrochloride	Dr. Reddy's Laboratories Limited	55111-130	ORAL	300 mg in 1 1	11/21/2018
Ranitidine	Physicians Total Care, Inc.	54868-5770	ORAL	150 mg in 1 mL	5/24/2012

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ZYNOL-150 TABLET 150 mg	MICRO LABS LTD	SIN10248P	TABLET, FILM COATED	150 mg	10/10/1998
HYZAN TABLET 150 mg	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN10146P	TABLET, FILM COATED	150 mg	10/2/1998
GASTRIL INJECTION 50 mg/2 ml	DUOPHARMA (M) SDN BHD	SIN10081P	INJECTION	50 mg/2 ml	9/25/1998
APO-RANITIDINE TABLET 150 mg	APOTEX INC	SIN05429P	TABLET, FILM COATED	150 mg	2/18/1991
ACILOC 150 TABLET 150 mg	CADILA PHARMACEUTICALS LTD	SIN11750P	TABLET, FILM COATED	150 mg	12/26/2001
ACILOC 300 TABLET 300 mg	CADILA PHARMACEUTICALS LTD	SIN11751P	TABLET, FILM COATED	300 mg	12/26/2001

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ZANTAC ranitidine 150mg (as hydrochloride) tablets	445896	Aspen Pharmacare Australia Pty Ltd	Medicine	A	4/18/2024
RANI 2 ranitidine 300mg (as hydrochloride) tablet bottle	285694	Alphapharm Pty Ltd	Medicine	A	6/29/2017
RANI 2 ranitidine 150mg (as hydrochloride) tablet bottle	285695	Alphapharm Pty Ltd	Medicine	A	6/29/2017
CHEMISTS' OWN ACID & HEARTBURN RELIEF RANITIDINE 150mg (as hydrochloride) tablet blister pack	123670	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/17/2005
ZANTAC DOUBLE STRENGTH ranitidine 300mg (as hydrochloride) tablet blister pack	95076	Aspen Pharmacare Australia Pty Ltd	Medicine	A	7/11/2003
MEDREICH RANITIDINE 300 MG TABLETS BP (as hydrochloride) blister pack	146798	Medreich Australia Pty Ltd	Medicine	A	10/30/2007
RANI 2 ranitidine 150mg (as hydrochloride) tablet blister pack	285696	Alphapharm Pty Ltd	Medicine	A	6/29/2017
AUSRAN ranitidine 300mg (as hydrochloride) tablet bottle	104815	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/3/2004
CHEMISTS' OWN ACID & HEARTBURN RELIEF RANITIDINE DOUBLE STRENGTH ranitidine 300mg (as hydrochloride) tablet blister pack	123658	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/17/2005
AUSRAN ranitidine 150mg (as hydrochloride) tablet blister pack	97354	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/7/2003

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MED RANITIDINE TABLETS 150MG	medican pharma incorporated	02219077	Tablet - Oral	150 MG	4/6/1999
ZANTAC	glaxo canada inc	00603791	Liquid - Intramuscular , Intravenous	25 MG / ML	12/31/1984
ZANTAC ORAL SOLUTION 15MG/ML	glaxo canada inc	00782386	Solution - Oral	15 MG / ML	12/31/1989

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
RANITIDINA DURBAN 150 mg COMPRIMIDOS RECUBIERTOS EFG	Laboratorios Francisco Durban S.A.	63810	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
RANITIDINA ARAFARMA GROUP 150 mg COMPRIMIDOS RECUBIERTOS EFG	Arafarma Group S.A.	63820	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
RANITIDINA MABO 150 mg COMPRIMIDOS RECUBIERTOS EFG	Mabo Farma S.A.	61130	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ZANTAC 300 mg, COMPRIMIDOS RECUBIERTOS CON PELICULA	Glaxosmithkline S.A.	57835	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
RANITIDINA ARAFARMA GROUP 300 mg COMPRIMIDOS RECUBIERTOS EFG	Arafarma Group S.A.	63821	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ZANTAC 150 mg, COMPRIMIDOS RECUBIERTOS CON PELICULA	Glaxosmithkline S.A.	56004	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
RANITIDINA ARISTO 150 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Aristo Pharma Iberia S.L.	70952	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized
RANITIDINA ARISTO 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Aristo Pharma Iberia S.L.	70953	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
RANITIDINA DURBAN 300 mg COMPRIMIDOS EFG	Laboratorios Francisco Durban S.A.	63811	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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