Regulatory PathRegulatory requirements compared

Active substance

Mefenamic acid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FENAM 250MG TAB250 mgFilm-coated tablet · Oral use20 BlisterSAR 5.85Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
FENAM 50MG-5ML SYRUP10 mg/mlSyrup · Oral use1 BottleSAR 12.60Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
FENAM FORTE 500MG TAB500 mgFilm-coated tablet · Oral use20 BlisterSAR 9.95Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
FENAMIC 250 MG CAP250 mgCapsule · Oral use24 BlisterSAR 5.65Generic · PrescriptionKUWAIT SAUDI PHARMACEUTICAL INDUSTRIESValid
PONSTAN FORTE 500 mg film-coated tablet500 mgFilm-coated tablet · Oral use20 BlisterSAR 15.30NCE · PrescriptionPFIZERValid
FENDOL 250 MG CAPSULE250 mgCapsule · Oral use20 BlisterSAR 4.55NCE · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
FENDOL 50MG-5ML SUSP10 mg/mlOral suspension · Oral use1 BottleSAR 8.65Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
FENDOL D.S.TAB 500MG500 mgFilm-coated tablet · Oral use20 BlisterSAR 7.35Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
MAFEPAIN 500MG TAB500 mgFilm-coated tablet · Oral use20 BlisterSAR 8.95Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
PANGESIC 250MG CAPS250 mgCapsule · Oral use20 BlisterSAR 4.10Generic · PrescriptionRam Pharmaceutical IndustriesWithdrawn by MAH · Not Marketed
PONSTAN SYRUP 50MG-5ML10 mg/mlSyrup · Oral use1 BottleSAR 19.90NCE · PrescriptionPARK-DAVISWithdrawn by MAH · Not Marketed
TABIGESIC 250MG TAB250 mgTablet · Oral use20 BlisterSAR 4.00Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
TABIGESIC 50MG-5ML SUSP.10 mg/mlOral suspension · Oral use1 BottleSAR 11.35NCE · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
TABIGESIC FORTE TAB500 mgTablet · Oral use20 BlisterSAR 8.10Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; ANKYLOSING SPONDYLITIS; CHRONIC PANCREATITIS; DENTAL ABSCESS-DENTAL PAIN; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; EPIDERMOLYSIS BULLOSA; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LOW BACK PAIN; MENSTRUAL DISORDERS; MIGRAINE/ HEADACHE; MUCOSAL ULCERATION-SUPPORTIVE AGENTS; NON-INFECTIOUS UVEITIS; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RENAL AND URETERIC STONES; RHEUMATOID ARITHRITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
PONSTEL250MGcapsule · oralAVION PHARMSPrescription28 Mar 1967
MEFENAMIC ACID250MGcapsule · oralMICRO LABSPrescription19 Nov 2010
MEFENAMIC ACID250MGcapsule · oralLUPIN LTDPrescription22 Jul 2011
MEFENAMIC ACID250MGcapsule · oralAJENAT PHARMSPrescription2 Jun 2014
MEFENAMIC ACID250MGcapsule · oralMPP PHARMADiscontinued5 Feb 2013
MEFENAMIC ACID250MGcapsule · oralCHARTWELL RXDiscontinued18 Sep 2020

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MEFENAMIC02229452250 MGCAPSULE · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMEFENAMIC ACID 250 MG CAPSULE$0.94789per EA23 Sep 2026
NHS Drug TariffMefenamic acid 250mg capsules£12.72100 capsule1 Oct 2026
NHS Drug TariffMefenamic acid 250mg tablets£7.2228 tablet1 Oct 2026
NHS Drug TariffMefenamic acid 500mg tablets£14.9428 tablet1 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 31 Dec 2025 PONSTEL — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for mefenamic acid →

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.