Active substance
Nabumetone
- US FDA 15
- Health Canada 1
- US price lines 3
- NHS prices 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NABUMETONE | 500MG; 750MG | tablet · oral | CHARTWELL RX | Prescription | 25 Feb 2002 |
| NABUMETONE | 500MG; 750MG | tablet · oral | CHARTWELL MOLECULES | Prescription | 24 Jan 2003 |
| NABUMETONE | 500MG; 750MG | tablet · oral | INVAGEN PHARMS | Prescription | 7 Mar 2008 |
| NABUMETONE | 500MG; 750MG | tablet · oral | SCIEGEN PHARMS | Prescription | 24 Sep 2008 |
| NABUMETONE | 500MG; 750MG | tablet · oral | ANNORA PHARMA | Prescription | 12 Jan 2011 |
| NABUMETONE | 500MG; 750MG | tablet · oral | WATSON LABS | Prescription | 13 Jun 2011 |
| NABUMETONE | 500MG; 750MG; 1GM | tablet · oral | LGM PHARMA | Prescription | 30 Aug 2019 |
| NABUMETONE | 500MG; 750MG | tablet · oral | NOVITIUM PHARMA | Prescription | 7 Jan 2025 |
| RELAFEN | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | SMITHKLINE BEECHAM | Discontinued | 24 Dec 1991 |
| NABUMETONE | 500MG; 750MG | tablet · oral | IMPAX LABS INC | Discontinued | 26 May 2000 |
| NABUMETONE | 750MG | tablet · oral | COPLEY PHARM | Discontinued | 6 Jun 2000 |
| NABUMETONE | 500MG; 750MG | tablet · oral | EPIC PHARMA LLC | Discontinued | 25 Feb 2002 |
| NABUMETONE | 500MG; 750MG | tablet · oral | OXFORD PHARMS | Discontinued | 27 Feb 2009 |
| NABUMETONE | 500MG; 750MG | tablet · oral | AUROBINDO PHARMA USA | Discontinued | 12 Jul 2010 |
| NABUMETONE | 500MG; 750MG | tablet · oral | PHARMAZONE | Discontinued | 30 Dec 2011 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| NABUMETONE | 02238639 | 500 MG | TABLET · ORAL | AA PHARMA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | NABUMETONE 500 MG TABLET | $0.12816 | per EA | 23 Sep 2026 |
| US NADAC | NABUMETONE 750 MG TABLET | $0.18332 | per EA | 23 Sep 2026 |
| US NADAC | RELAFEN DS 1,000 MG TABLET | $31.66667 | per EA | 17 Jun 2026 |
| NHS Drug Tariff | Nabumetone 500mg tablets | £173.27 | 56 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
- EMA PRAC 14 Jun 2018 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
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.