Regulatory PathRegulatory requirements compared

Active substance

Indometacin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
INDOMIN CAP 25MG25 mgCapsule · Oral use20 BlisterSAR 2.25Generic · PrescriptionHikma Pharmaceuticals PLCValid
ROTHACIN 100MG SUPPOSITORIES100 mgSuppository · Rectal use10 BlisterSAR 13.20Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
INDOCID 100MG SUPPOSITORIES100 mgSuppository · Rectal use10 BlisterSAR 25.35Generic · PrescriptionAlgorithm SALSuspended
CONFORTID 25MG CAPS25 mgCapsule · Oral use24 BlisterSAR 11.20Generic · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed
CONFORTID 50MG SUPPOSITORY50 mgSuppository · Rectal use10 BlisterSAR 15.80Generic · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed
CONFORTID INJ I.V 50MG50 mg/mlSolution · Intravenous use10 VialSAR 277.85NCE · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed
CONFORTID INJ I.V 50MG50 mg/mlSolution · Intravenous use3 VialSAR 100.05NCE · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed
CONFORTID SUPPOSITORIES 100 MG.100 mgSuppository · Rectal use10 BlisterSAR 21.55Generic · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed
CONFORTID SYRUP 5MG-ML5 mg/mlSyrup · Oral use1 BottleSAR 23.25NCE · PrescriptionXELLIA PHARMACEUTICAL APSWithdrawn by MAH · Not Marketed
INDOCID75 mgCapsule · Oral use30 BlisterSAR 26.50NCE · PrescriptionMERCK SHARP & DOHMEWithdrawn by MAH · Not Marketed
INDOCID 100 MG SUPP100 mgSuppository · Rectal use10 BlisterSAR 22.05Generic · PrescriptionAlgorithm SALWithdrawn by MAH · Not Marketed
INDOCID 100 MG SUPP100 mgSuppository · Rectal use5 BlisterSAR 12.75NCE · PrescriptionMERCK SHARP & DOHMEWithdrawn by MAH · Not Marketed
INDOCID 2525 mgCapsule · Oral use30 BlisterSAR 13.95NCE · PrescriptionMERCK SHARP & DOHMEWithdrawn by MAH · Not Marketed
INDOGESIC CAP 25MG25 mgCapsule · Oral use30 BlisterSAR 3.45Generic · PrescriptionDAR ALDAWAWithdrawn by MAH · Not Marketed
INDOMETHACIN CAPS 25MG25 mgCapsule · Oral use30 BlisterSAR 7.40Generic · PrescriptionMISR COMPANY FOR MEDICAL PRODUCTSWithdrawn by regulatory authority · Not Marketed
INDOMIN 100MG SUPP100 mgSuppository · Rectal use6 BlisterSAR 2.40Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
METHACIN CAPS. 25MG25 mgCapsule · Oral use24 BlisterSAR 2.45Generic · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
METHACIN SUPP. 100 MG100 mgSuppository · Rectal use5 BlisterSAR 1.90Generic · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
ROTHACIN CAPS 25 MG25 mgCapsule · Oral use30 BlisterSAR 9.75Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn 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; GOUT; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LOW BACK PAIN; MENSTRUAL DISORDERS; MUCOSAL ULCERATION-SUPPORTIVE AGENTS; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RENAL AND URETERIC STONES; RHEUMATOID ARITHRITIS; SICKLE CELL DISEASE - PAIN MANAGEMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
INDOMETHACIN50MG; 25MGcapsule · oralCHARTWELL MOLECULESPrescription6 Aug 1984
INDOCIN25MG/5MLsuspension · oralCOSETTEPrescription10 Oct 1985
INDOMETHACIN50MGcapsule · oralCHARTWELL MOLECULESPrescription5 Mar 1986
INDOMETHACIN25MGcapsule · oralSANDOZPrescription29 Apr 1987
INDOMETHACIN50MGcapsule · oralSANDOZPrescription29 Apr 1987
INDOMETHACIN50MGsuppository · rectalCOSETTEPrescription31 Aug 1992
INDOMETHACIN75MGcapsule, extended release · oralAVANTHI INCPrescription6 Mar 2009
INDOMETHACINEQ 1MG BASE/VIALinjectable · injectionFRESENIUS KABI USAPrescription17 Mar 2010
INDOMETHACIN25MG; 50MGcapsule · oralZYDUS LIFESCIENCESPrescription15 Nov 2010
INDOMETHACIN75MGcapsule, extended release · oralCHARTWELL RXPrescription30 Nov 2010
INDOMETHACIN75MGcapsule, extended release · oralAMNEAL PHARMSPrescription1 Dec 2010
INDOMETHACIN25MG; 50MGcapsule · oralGLENMARK PHARMS LTDPrescription22 Dec 2010
INDOMETHACIN25MG; 50MGcapsule · oralHETERO LABS LTD IIIPrescription12 Apr 2011
INDOMETHACIN75MGcapsule, extended release · oralHETERO LABS LTD IIIPrescription28 Sep 2012
INDOMETHACIN75MGcapsule, extended release · oralNOVAST LABSPrescription8 May 2017
INDOMETHACIN75MGcapsule, extended release · oralGLENMARK PHARMS LTDPrescription22 Jun 2017
INDOMETHACIN75MGcapsule, extended release · oralZYDUS PHARMSPrescription25 Sep 2017
INDOMETHACIN50MGsuppository · rectalZYDUS LIFESCIENCESPrescription2 Aug 2023
INDOMETHACIN25MG/5MLsuspension · oralNOVITIUM PHARMAPrescription12 Jan 2024
INDOMETHACIN50MGsuppository · rectalHIKMA PHARMSPrescription19 Nov 2024
INDOMETHACIN50MGsuppository · rectalAMNEALPrescription24 Feb 2025
INDOMETHACIN50MGsuppository · rectalANNORA PHARMAPrescription3 Jul 2025
INDOCIN25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralZYLA LIFE SCIENCESDiscontinued10 Jun 1965
INDOCIN SR75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule, extended release · oralZYLADiscontinued23 Feb 1982
INDOMETHACIN25MG; 50MGcapsule · oralRISINGDiscontinued20 Apr 1984

50 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AURO-INDOMETHACIN0249922350 MGCAPSULE · ORALAURO PHARMA INC
MINT-INDOMETHACIN0246153650 MGCAPSULE · ORALMINT PHARMACEUTICALS INC
MINT-INDOMETHACIN0246181125 MGCAPSULE · ORALMINT PHARMACEUTICALS INC
ODAN-INDOMETHACIN0223179950 MG / SUPSUPPOSITORY · RECTALODAN LABORATORIESLTD
ODAN-INDOMETHACIN02231800100 MG / SUPSUPPOSITORY · RECTALODAN LABORATORIESLTD
TEVA-INDOMETHACIN0033742025 MGCAPSULE · ORALTEVA CANADA LIMITED
TEVA-INDOMETHACIN0033743950 MGCAPSULE · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACINDOMETHACIN 25 MG CAPSULE$0.09341per EA23 Sep 2026
US NADACINDOMETHACIN 50 MG CAPSULE$0.13013per EA23 Sep 2026
US NADACINDOMETHACIN ER 75 MG CAPSULE$0.20992per EA23 Sep 2026
NHS Drug TariffIndometacin 100mg suppositories£17.6110 suppository1 Oct 2026
NHS Drug TariffIndometacin 25mg capsules£19.3028 capsule1 Oct 2026
NHS Drug TariffIndometacin 50mg capsules£34.7228 capsule1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 22.7. Medicines administered to the neonate [c] · complementary
    Therapeutic equivalent to ibuprofen for Patent arterial duct

Safety signals and safety-related labeling changes

  • US FDA 21 Nov 2024 INDOCIN — 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
  • US FDA 21 Nov 2024 INDOCIN — 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
  • US FDA 21 Nov 2024 INDOCIN — 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
  • US FDA 21 Nov 2024 INDOCIN SR — 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
  • US FDA 21 Nov 2024 INDOMETHACIN — 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
  • US FDA 21 Nov 2024 INDOMETHACIN — 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
  • US FDA 21 Nov 2024 INDOMETHACIN — 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
  • US FDA 28 Apr 2021 TIVORBEX — 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
  • US FDA 26 Mar 2021 INDOCIN — safety-related labeling change
    Labeling sections changed: Adverse Reactions

All safety entries for indometacin →

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.