Regulatory PathRegulatory requirements compared

Active substance

Pethidine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PETHIDINE PETHIDINE 50 mg/ml injection BP50 mg/mlInjection · Intramuscular and intravenous use10 AmpouleSAR 30.10Generic · PrescriptionMACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALSValid
PETHIDINE PETHIDINE 50 mg/ml injection BP50 mg/mlInjection · Intramuscular and intravenous use10 AmpouleSAR 30.10Generic · PrescriptionMACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALSValid
Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; ANESTHESIA; ENDOMETRIOSIS; POSTOPERATIVE PAIN

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

ProductStrengthForm · routeApplicantStatusFirst approved
DEMEROL25MG/ML; 50MG/ML; 75MG/ML; 100MG/MLinjectable · injectionHOSPIRAPrescription10 Nov 1942
MEPERIDINE HYDROCHLORIDE25MG/ML; 50MG/ML; 75MG/ML; 100MG/MLinjectable · injectionWEST-WARD PHARMS INTPrescription26 Apr 1972
MEPERIDINE HYDROCHLORIDE25MG/ML; 50MG/ML; 75MG/ML; 100MG/MLinjectable · injectionWEST-WARD PHARMS INTPrescription22 Jan 1975
MEPERIDINE HYDROCHLORIDE50MG/5MLsyrup · oralHIKMA PHARMSPrescription30 Jan 1985
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE10MG/MLinjectable · injectionWEST-WARD PHARMS INTPrescription30 Jul 1993
MEPERIDINE HYDROCHLORIDE50MG; 100MGtablet · oralEPIC PHARMA LLCPrescription28 May 1999
MEPERIDINE HYDROCHLORIDE50MGtablet · oralGENUSPrescription24 Jun 2009
DEMEROL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralQUAGENDiscontinued10 Nov 1942
DEMEROL50MG/ML; 100MG/ML; 25MG/ML; 75MG/MLinjectable · injectionQUAGENDiscontinued10 Nov 1942
DEMEROL50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**syrup · oralQUAGENDiscontinued10 Nov 1942
MEPERIDINE HYDROCHLORIDE50MGtablet · oralWYETH AYERSTDiscontinued31 Jul 1973
MEPERIDINE HYDROCHLORIDE100MG/ML; 50MG/ML; 75MG/MLinjectable · injectionPARKE DAVISDiscontinued19 May 1976
MEPERIDINE HYDROCHLORIDE50MG; 100MGtablet · oralSUN PHARM INDUSTRIESDiscontinued15 Oct 1976
MEPERIDINE HYDROCHLORIDE25MG/MLinjectable · injectionBAXTER HLTHCAREDiscontinued15 Jun 1984
MEPERIDINE HYDROCHLORIDE50MG/MLinjectable · injectionBAXTER HLTHCAREDiscontinued15 Jun 1984
MEPERIDINE HYDROCHLORIDE75MG/MLinjectable · injectionBAXTER HLTHCAREDiscontinued15 Jun 1984
MEPERIDINE HYDROCHLORIDE100MG/MLinjectable · injectionBAXTER HLTHCAREDiscontinued15 Jun 1984
MEPERIDINE HYDROCHLORIDE50MGtablet · oralBARRDiscontinued2 Jul 1984
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE10MG/MLinjectable · injectionICU MEDICAL INCDiscontinued16 Aug 1984
MEPERIDINE HYDROCHLORIDE100MGtablet · oralBARRDiscontinued19 Sep 1984
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE10MG/MLinjectable · injectionWATSON LABSDiscontinued17 Mar 1992
MEPERIDINE HYDROCHLORIDE50MG/MLinjectable · injectionWATSON LABSDiscontinued17 Mar 1992
MEPERIDINE HYDROCHLORIDE100MG/MLinjectable · injectionWATSON LABSDiscontinued17 Mar 1992
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE10MG/MLinjectable · injectionINTL MEDICATIONDiscontinued30 Aug 1993
MEPERIDINE HYDROCHLORIDE50MG; 100MGtablet · oralHIKMA PHARMSDiscontinued12 Mar 1997

22 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
MEPERIDINE HYDROCHLORIDE INJECTION USP0072576550 MG / MLSOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMEPERIDINE 50 MG/5 ML SOLUTION$0.15672per ML23 Sep 2026
NHS Drug TariffPethidine 100mg/2ml solution for injection ampoules£4.6610 ampoule1 Oct 2026
NHS Drug TariffPethidine 50mg/1ml solution for injection ampoules£5.1110 ampoule1 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 22 Dec 2025 DEMEROL — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 DEMEROL — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 MEPERGAN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pethidine →

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.