Active substances
Diclofenac + Misoprostol
- US FDA 8
- Health Canada 6
- US price lines 4
- NHS prices 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ARTHROTEC | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | PFIZER | Prescription | 24 Dec 1997 |
| DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | ACTAVIS LABS FL INC | Prescription | 9 Jul 2012 |
| DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | AMNEAL PHARMS | Prescription | 25 Nov 2016 |
| DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | YUNG SHIN PHARM | Prescription | 19 Feb 2020 |
| DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | MICRO LABS | Prescription | 15 Jul 2021 |
| DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | SANDOZ | Discontinued | 9 May 2013 |
| DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | EXELA HOLDINGS | Discontinued | 14 Mar 2014 |
| DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG; 75MG;0.2MG | tablet, delayed release · oral | ZYDUS PHARMS | Discontinued | 12 Jun 2023 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ARTHROTEC 50 | 01917056 | 200 MCG; 50 MG | TABLET (DELAYED-RELEASE) · ORAL | PFIZER CANADA ULC |
| ARTHROTEC 75 | 02229837 | 200 MCG; 75 MG | TABLET (DELAYED-RELEASE) · ORAL | PFIZER CANADA ULC |
| GD-DICLOFENAC/MISOPROSTOL 50 | 02341689 | 200 MCG; 50 MG | TABLET (DELAYED-RELEASE) · ORAL | GENMED A DIVISION OF PFIZER CANADA ULC |
| GD-DICLOFENAC/MISOPROSTOL 75 | 02341697 | 200 MCG; 75 MG | TABLET (DELAYED-RELEASE) · ORAL | GENMED A DIVISION OF PFIZER CANADA ULC |
| PMS-DICLOFENAC-MISOPROSTOL | 02413469 | 200 MCG; 50 MG | TABLET (DELAYED-RELEASE) · ORAL | PHARMASCIENCE INC |
| PMS-DICLOFENAC-MISOPROSTOL | 02413477 | 200 MCG; 75 MG | TABLET (DELAYED-RELEASE) · ORAL | PHARMASCIENCE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ARTHROTEC 50 MG-200 MCG TAB | $8.54949 | per EA | 22 Apr 2026 |
| US NADAC | ARTHROTEC 75 MG-200 MCG TAB | $8.47483 | per EA | 23 Sep 2026 |
| US NADAC | DICLOFENAC-MISOPROSTOL DR 50-0.2 MG TABLET | $0.66455 | per EA | 23 Sep 2026 |
| US NADAC | DICLOFENAC-MISOPROSTOL DR 75-0.2 MG TABLET | $0.96624 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Diclofenac sodium 50mg gastro-resistant / Misoprostol 200microgram tablets | £11.98 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Diclofenac sodium 75mg gastro-resistant / Misoprostol 200microgram tablets | £15.83 | 60 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.
Components
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.