Regulatory PathRegulatory requirements compared

Active substance

Ephedrine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
EPHEDRINE HYDROCHLORIDE 30 mg/ml solution for injction30 mg/mlSolution for injection · Parenteral use10 AmpouleSAR 49.00Generic · PrescriptionMACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALSValid
Ephedrine 3 mg/ml , solution for injection in pre-filled syringe3 mg/mlSolution for injection in pre-filled syringe · Intravenous use10 Pre-filled syringeSAR 273.05NCE · PrescriptionAGUETTANT LABORATORIESValid
Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; HYPOTENSION

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

ProductStrengthForm · routeApplicantStatusFirst approved
AKOVAZ50MG/ML (50MG/ML); 25MG/5ML (5MG/ML)solution · intravenousEXELA PHARMAPrescription29 Apr 2016
CORPHEDRA50MG/ML (50MG/ML)solution · intravenousPH HEALTHPrescription27 Jan 2017
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousSANDOZPrescription23 Aug 2017
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousAMNEALPrescription23 Oct 2019
EMERPHED50MG/10ML (5MG/ML); 25MG/5ML (5MG/ML)solution · intravenousNEXUSPrescription17 Apr 2020
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousFRESENIUS KABI USAPrescription4 Aug 2020
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousDR REDDYSPrescription3 Oct 2020
EPHEDRINE SULFATE50MG/10ML (5MG/ML); 25MG/5ML (5MG/ML)solution · intravenousPH HEALTHPrescription16 Oct 2020
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousHIKMA PHARMSPrescription15 Dec 2020
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousEUGIA PHARMAPrescription14 Jun 2021
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousGLANDPrescription25 Feb 2022
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousMANKIND PHARMAPrescription14 Apr 2022
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousXIROMEDPrescription21 Apr 2022
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousSAGENT PHARMS INCPrescription9 Mar 2023
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousCAPLINPrescription18 Jul 2024
EPHEDRINE SULFATE25MG/5ML (5MG/ML)solution · intravenousHIKMAPrescription11 Oct 2024
EPHEDRINE SULFATE50MG/10ML (5MG/ML)solution · intravenousGLANDPrescription16 Jan 2025
EPHEDRINE SULFATE25MG/5ML (5MG/ML); 50MG/10ML (5MG/ML)solution · intravenousFRESENIUS KABI USAPrescription11 Mar 2025
EPHEDRINE SULFATE50MG/10ML (5MG/ML)solution · intravenousFRESENIUS KABI USAPrescription19 Mar 2026
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousBAXTER HLTHCARE CORPPrescription8 Jul 2026
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousRENEW PHARMSDiscontinued1 Mar 2017
REZIPRES23.5MG/5ML (4.7MG/ML); 47MG/ML (47MG/ML); 47MG/5ML (9.4MG/ML); 47MG/10ML (4.7MG/ML)solution · intravenousDR REDDYS LABS SADiscontinued14 Jun 2021
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousZYDUS PHARMSDiscontinued16 May 2023
EPHEDRINE SULFATE50MG/ML (50MG/ML)solution · intravenousCIVICADiscontinued23 Dec 2025

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
EPHEDRINE SULFATE INJECTION USP0087653450 MG / MLSOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULARSANDOZ CANADA INCORPORATED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffEphedrine hydrochloride 15mg tablets£125.0028 tablet1 Oct 2026
NHS Drug TariffEphedrine hydrochloride 30mg tablets£180.0028 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.

WHO WHO Model List of Essential Medicines (2025)

  • 1.2. Local anaesthetics · complementary
    Cardiac complications of anaesthesia during labour or delivery
    Parenteral > Locoregional injections > Spinal anaesthesia: 30 mg per mL in 1 mL ampoule (ephedrine hydrochloride)

Safety signals and safety-related labeling changes

All safety entries for ephedrine →

Combinations containing Ephedrine

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.