Is Dopamine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Dopamine, including DOMINE 40 mg/ml concentrate for solution for infusion (40 mg/ml, Concentrate for solution for infusion, SAR 113.85); Domine (40 mg/ml, Infusion, SAR 1138.50); Dopamine Fresenius 200 mg/5 ml (40 mg/ml, Concentrate for solution for infusion, SAR 163.40); Dopamine Hydrochloride in 5% Dextrose, 1600 mcg/ml (1600 µ/ml, Solution for injection/infusion, SAR 687.10); Dopamine Hydrochloride in 5% Dextrose, 3200 mcg/ml (3200 µ/ml, Solution for injection/infusion, SAR 1374.20).

Is Dopamine approved by the US FDA?

Drugs@FDA lists 38 application product lines for Dopamine, including DOPAMINE HYDROCHLORIDE (Prescription); DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (Prescription); DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER (Prescription); DOPAMINE HYDROCHLORIDE (Prescription); INTROPIN (Discontinued).

Is Dopamine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dopamine: Neoatricon.

Is Dopamine on the WHO Model List of Essential Medicines?

Yes — 12.4. Medicines used in heart failure (complementary list): Cardiogenic shock; Heart failure.

Active substance

Dopamine

SFDA 9
US FDA 38
EMA 1
WHO EML 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DOMINE 40 mg/ml concentrate for solution for infusion	40 mg/ml	Concentrate for solution for infusion · Intravenous use	5 Ampoule	SAR 113.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Domine	40 mg/ml	Infusion · Intravenous use	50 Ampoule	SAR 1138.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Dopamine Fresenius 200 mg/5 ml	40 mg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 163.40	Generic · Prescription	Fresenius Kabi Deutschland GmbH	Valid
Dopamine Hydrochloride in 5% Dextrose, 1600 mcg/ml	1600 µ/ml	Solution for injection/infusion · Intravenous use	18 Bag	SAR 687.10	Prescription	BAXTER HEALTHCARE CORPORATION	Valid
Dopamine Hydrochloride in 5% Dextrose, 3200 mcg/ml	3200 µ/ml	Solution for injection/infusion · Intravenous use	18 Bag	SAR 1374.20	NCE · Prescription	BAXTER HEALTHCARE CORPORATION	Valid
DOPAMIN HCL 40MG-ML INJ VIAL	40 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 33.70	NCE · Prescription	HOSPIRA INC	Withdrawn by MAH · Not Marketed
DOPAMIN HCL INJ 40MG-ML	40 mg/ml	Injection · Intravenous use	5 Vial	SAR 25.30	NCE · Prescription	HOSPIRA INC	Withdrawn by MAH · Not Marketed
DOPAMIN HCL INJ 40MG-ML SYRING	40 mg/ml	Solution for injection · Intravenous use	1 Pre-filled syringe	SAR 33.70	NCE · Prescription	HOSPIRA INC	Withdrawn by MAH · Not Marketed
DOPAMINE HCL 200MG-5ML AMP	40 mg/ml	Injection · Intravenous use	5 Ampoule	SAR 70.90	Generic · Prescription	HOSPIRA AUSTRALIA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE KIDNEY INJURY (AKI); ANAPHYLACTIC SHOCK; ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; BRADYCARDIA; HYPOTENSION; Septic Shock

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

Product	Strength	Form · route	Applicant	Status	First approved
DOPAMINE HYDROCHLORIDE	40MG/ML; 80MG/100ML; 160MG/100ML; 80MG/ML	injectable · injection	HOSPIRA	Prescription	19 May 1981
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML; 160MG/100ML; 320MG/100ML	injectable · injection	HOSPIRA	Prescription	30 Sep 1983
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML; 160MG/100ML; 320MG/100ML; 640MG/100ML	injectable · injection	BAXTER HLTHCARE	Prescription	27 Mar 1987
DOPAMINE HYDROCHLORIDE	40MG/ML; 80MG/ML	injectable · injection	HIKMA INTL PHARMS	Prescription	11 Apr 2018
INTROPIN	40MG/ML; 80MG/ML; 160MG/ML	injectable · injection	HOSPIRA	Discontinued	25 Feb 1974
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	INTL MEDICATION	Discontinued	19 May 1981
DOPAMINE HYDROCHLORIDE	40MG/ML; 80MG/ML	injectable · injection	BAXTER HLTHCARE	Discontinued	6 Jul 1981
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	TELIGENT	Discontinued	28 Jun 1983
DOPAMINE HYDROCHLORIDE	80MG/ML	injectable · injection	IGI LABS INC	Discontinued	23 Oct 1985
DOPAMINE HYDROCHLORIDE	160MG/ML	injectable · injection	IGI LABS INC	Discontinued	23 Oct 1985
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER	40MG/100ML; 160MG/100ML	injectable · injection	B BRAUN	Discontinued	15 Oct 1986
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%	80MG/100ML; 320MG/100ML	injectable · injection	B BRAUN	Discontinued	15 Oct 1986
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	AM REGENT	Discontinued	11 Feb 1987
DOPAMINE HYDROCHLORIDE	80MG/ML	injectable · injection	AM REGENT	Discontinued	11 Feb 1987
DOPAMINE HYDROCHLORIDE	160MG/ML	injectable · injection	AM REGENT	Discontinued	11 Feb 1987
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	TEVA PARENTERAL	Discontinued	23 Oct 1991
DOPAMINE HYDROCHLORIDE	80MG/ML	injectable · injection	TEVA PARENTERAL	Discontinued	23 Oct 1991
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%	1.6MG/ML	injectable · injection	HOSPIRA	Discontinued	30 Aug 1995
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	HOSPIRA	Discontinued	23 May 1996
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	SMITH AND NEPHEW	Discontinued
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	ABRAXIS PHARM	Discontinued
DOPAMINE HYDROCHLORIDE	80MG/ML	injectable · injection	ABRAXIS PHARM	Discontinued
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	SMITH AND NEPHEW	Discontinued
DOPAMINE HYDROCHLORIDE	80MG/ML	injectable · injection	SMITH AND NEPHEW	Discontinued
DOPAMINE HYDROCHLORIDE	40MG/ML	injectable · injection	ABRAXIS PHARM	Discontinued

13 more — full table

EMA European Union — centrally authorised medicines

Neoatricon BrePco Biopharma Limited · Authorised · authorised 27 May 2024 · ATC C01CA04

Therapeutic indication (EMA)

Treatment of hypotension in haemodynamically unstable neonates, infants and children < 18 years

WHO WHO Model List of Essential Medicines (2025)

12.4. Medicines used in heart failure · complementary
Cardiogenic shock; Heart failure
Parenteral > General injections > IV: 40 mg per mL in 5 mL vial (hydrochloride)

Combinations containing Dopamine

Dextrose + dopamine

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.