Active substance
Rabeprazole
- SFDA 6
- US FDA 14
- Health Canada 8
- US price lines 1
- NHS prices 2
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PARIET 20MG E.C TAB | 20 mg | Tablet · Oral use | 14 Blister | SAR 19.70 | NCE · Prescription | Janssen-Cilag International NV | Valid |
| RAMEP 20 MG GASTRO-RESISTANT TABLET | 20 mg | Gastro-resistant tablet · Oral use | 28 Blister | SAR 30.15 | Generic · Prescription | SANDOZ | Valid |
| PARIET 10 MG E.C TAB | 10 mg | Tablet · Oral use | 14 Blister | SAR 36.81 | NCE · Prescription | Janssen-Cilag International NV | Withdrawn by MAH · Not Marketed |
| RABEZOLE 10MG E.C. TABLETS | 10 mg | Tablet · Oral use | 14 Bottle | SAR 24.35 | NCE · Prescription | Jamjoom Pharmaceuticals Factory Company | Suspended · Not Marketed |
| RABEZOLE 20MG E.C.TABLETS | 20 mg | Tablet · Oral use | 14 Blister | SAR 39.05 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Suspended · Not Marketed |
| RAMEP 10 MG GASTRO-RESISTANT TABLET | 10 mg | Gastro-resistant tablet · Oral use | 28 Blister | SAR 17.70 | Generic · Prescription | SANDOZ | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA-SUPPORTIVE AGENTS/ ASPIRATION PNEUMONIA PROPHYLAXIS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-SALVAGE THERAPIES; DENTAL ABSCESS-DENTAL PAIN; DYSPEPSIA; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; GASTROESOPHAGEAL REFLUX DISEASE (GERD); HIP AND KNEE REPLACEMENT SURGERY; LOW BACK PAIN; MIGRAINE/ HEADACHE; MYASTHENIA GRAVIS; PAIN MANAGEMENT IN CANCER PATIENTS; PEPTIC ULCER; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS-SUPPORTIVE CARE AND ADRS MANAGEMENT; THROMBOTIC THROMBOCYTOPENIC PURPURA; TUBERCULOSIS-SUPPORTIVE CARE
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ACIPHEX | 20MG | tablet, delayed release · oral | WAYLIS THERAP | Prescription | 19 Aug 1999 |
| ACIPHEX | 20MG | tablet, delayed release · oral | EISAI MEDCL RES | Prescription | 8 Nov 2002 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | DR REDDYS | Prescription | 8 Nov 2013 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | CHARTWELL RX | Prescription | 8 Nov 2013 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | LANNETT CO INC | Prescription | 8 Nov 2013 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | TORRENT | Prescription | 8 Nov 2013 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | AMNEAL PHARMS | Prescription | 31 Jul 2015 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | RUBICON RESEARCH | Prescription | 18 Nov 2015 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | QUAGEN | Prescription | 17 Feb 2017 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | ALKEM LABS LTD | Prescription | 24 Apr 2018 |
| ACIPHEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, delayed release · oral | WAYLIS THERAP | Discontinued | 19 Aug 1999 |
| ACIPHEX SPRINKLE | 5MG; 10MG | capsule, delayed release · oral | AYTU | Discontinued | 26 Mar 2013 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | TEVA PHARMS USA | Discontinued | 8 Nov 2013 |
| RABEPRAZOLE SODIUM | 20MG | tablet, delayed release · oral | PHARMOBEDIENT | Discontinued | 8 Nov 2013 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| PARIET, ENTERIC-COATED TABLET 10MG | 02243796 | 10 MG | TABLET (ENTERIC-COATED) · ORAL | JANSSEN INC |
| PARIET, ENTERIC-COATED TABLET 20MG | 02243797 | 20 MG | TABLET (ENTERIC-COATED) · ORAL | JANSSEN INC |
| RABEPRAZOLE | 02385449 | 10 MG | TABLET (ENTERIC-COATED) · ORAL | SIVEM PHARMACEUTICALS ULC |
| RABEPRAZOLE | 02385457 | 20 MG | TABLET (ENTERIC-COATED) · ORAL | SIVEM PHARMACEUTICALS ULC |
| RABEPRAZOLE EC | 02356511 | 10 MG | TABLET (ENTERIC-COATED) · ORAL | SANIS HEALTH INC |
| RABEPRAZOLE EC | 02356538 | 20 MG | TABLET (ENTERIC-COATED) · ORAL | SANIS HEALTH INC |
| SANDOZ RABEPRAZOLE | 02314177 | 10 MG | TABLET (ENTERIC-COATED) · ORAL | SANDOZ CANADA INCORPORATED |
| SANDOZ RABEPRAZOLE | 02314185 | 20 MG | TABLET (ENTERIC-COATED) · ORAL | SANDOZ CANADA INCORPORATED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | RABEPRAZOLE SOD DR 20 MG TAB | $0.22385 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Rabeprazole 10mg gastro-resistant tablets | £2.24 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Rabeprazole 20mg gastro-resistant tablets | £4.16 | 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 18 Jul 2023 ACIPHEX — 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 27 Nov 2020 ACIPHEX SPRINKLE — 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 - EMA PRAC 12 Jan 2017 PRAC signal: Incident chronic kidney disease (CKD) and progression to end stage renal disease (ESRD)
Action for MAH: update of the product information: No - EMA PRAC 1 Dec 2016 PRAC signal: Gastric polyps
Action for MAH: update of the product information: Yes - EMA PRAC 2 Sep 2016 PRAC signal: Incident chronic kidney disease (CKD) and progression to end stage renal disease (ESRD)
Action for MAH: update of the product information: No - EMA PRAC 8 Jul 2016 PRAC signal: Elevated circulating levels of chromogranin A
Action for MAH: update of the product information: Yes - EMA PRAC 17 Mar 2016 PRAC signal: Elevated circulating levels of chromogranin A
Action for MAH: update of the product information: No - EMA PRAC 9 Jul 2015 PRAC signal: Subacute cutaneous lupus erythematosus (SCLE)
Action for MAH: update of the product information: Yes
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.