Is Norepinephrine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Norepinephrine, including EPINOR 1 mg/ml Injection (1 mg/ml, Injection, SAR 43.15); LEVOPHED (1 mg/ml, Solution for injection, SAR 189.75); NEVOLEEN 1 mg/ml Ampoule (1 mg/ml, Concentrate for solution for infusion, SAR 115.15); NOREPINEPHRINE (1 mg/ml, Concentrate for solution for infusion, SAR 77.70); NOREPIRIN 2 mg/ml Injection (2 mg/ml, Injection, SAR 86.35).

Is Norepinephrine approved by the US FDA?

Drugs@FDA lists 27 application product lines for Norepinephrine, including LEVOPHED (Prescription); NOREPINEPHRINE BITARTRATE (Prescription); NOREPINEPHRINE BITARTRATE (Prescription); NOREPINEPHRINE BITARTRATE (Prescription); NOREPINEPHRINE BITARTRATE (Prescription).

Are there safety signals or safety updates for Norepinephrine?

EMA PRAC: 1 entry (latest 2018-03-08).

Active substance

Norepinephrine

SFDA 8
US FDA 27
Health Canada 5
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EPINOR 1 mg/ml Injection	1 mg/ml	Injection · Intravenous use	5 Ampoule	SAR 43.15	Generic · Prescription	SAUDI PHARMACEUTICAL INDUSTRIES	Valid
LEVOPHED	1 mg/ml	Solution for injection · Intravenous use	10 Vial	SAR 189.75	NCE · Prescription	HOSPIRA INC	Valid
NEVOLEEN 1 mg/ml Ampoule	1 mg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 115.15	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
NOREPINEPHRINE	1 mg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 77.70	Generic · Prescription	AGUETTANT LABORATORIES	Valid
NOREPIRIN 2 mg/ml Injection	2 mg/ml	Injection · Intravenous use	10 Ampoule	SAR 86.35	Generic · Prescription	Huons Co., Ltd.	Valid
Noradrenalin Sintetica 4mg/4ml without disulphite	1 mg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 36.30	Generic · Prescription	Sintetica SA	Valid
Norepinephrine Kalceks	1 mg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 75.15	Generic · Prescription	AS Kalceks	Valid
Norphed	1 mg/ml	Concentrate for solution for infusion · Intravenous use	10 Ampoule	SAR 77.67	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

Indications — CHI Daman Drug Formulary

ACUTE KIDNEY INJURY (AKI); ANAPHYLACTIC SHOCK; BURN MANAGEMENT; HYPOTENSION; LIVER CIRRHOSIS; Septic Shock

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

Product	Strength	Form · route	Applicant	Status	First approved
LEVOPHED	EQ 1MG BASE/ML	injectable · injection	HOSPIRA	Prescription	13 Jul 1950
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	MEITHEAL	Prescription	3 Mar 2003
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	HIKMA PHARMS	Prescription	31 Oct 2003
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	BAXTER HLTHCARE CORP	Prescription	27 Mar 2012
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	MYLAN LABS LTD	Prescription	4 Oct 2018
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	SANDOZ	Prescription	18 Oct 2018
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	HIKMA	Prescription	7 Nov 2018
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	3 Nov 2020
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML); EQ 8MG BASE/250ML (EQ 32MCG BASE/ML); EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	solution · intravenous	BAXTER HLTHCARE CORP	Prescription	15 Jan 2021
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML); EQ 8MG BASE/250ML (EQ 32MCG BASE/ML); EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	solution · intravenous	BAXTER HLTHCARE CORP	Prescription	15 Jan 2021
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	BRECKENRIDGE	Prescription	22 Jan 2021
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	GLAND	Prescription	6 May 2021
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML); EQ 8MG BASE/250ML (EQ 32MCG BASE/ML); EQ 16MG BASE/250ML (EQ 64MCG BASE/ML); EQ 32MG BASE/250ML (EQ 128MCG BASE/ML)	solution · intravenous	INFORLIFE	Prescription	15 Sep 2022
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML); EQ 8MG BASE/250ML (EQ 32MCG BASE/ML); EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	solution · intravenous	LONG GROVE PHARMS	Prescription	6 Oct 2022
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	CAPLIN	Prescription	15 Sep 2023
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	RISING	Prescription	13 May 2024
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	ASPIRO	Prescription	31 Jan 2025
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	BIOCON PHARMA	Prescription	21 Mar 2025
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML); EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	solution · intravenous	SAGENT	Prescription	11 Aug 2025
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	ADAPTIS	Prescription	25 Nov 2025
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	MSN	Prescription	11 Dec 2025
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)	solution · intravenous	SAGENT	Prescription	26 Mar 2026
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	NEPHRON	Prescription	11 Jun 2026
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	METRICS PHARM	Discontinued	30 Sep 2004
NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	injectable · injection	AMNEAL	Discontinued	17 Dec 2018

2 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE INJECTION	02501430	0.016 MG / ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE INJECTION	02501449	0.032 MG / ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
NOREPINEPHRINE BITARTRATE INJECTION	02540630	1 MG / ML	SOLUTION · INTRAVENOUS	JUNO PHARMACEUTICALS CORP.
NOREPINEPHRINE BITARTRATE INJECTION USP	00893285	1 MG / ML	SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
NOREPINEPHRINE BITARTRATE INJECTION, USP	02358743	1 MG / ML	SOLUTION · INTRAVENOUS	STERIMAX INC

Safety signals and safety-related labeling changes

EMA PRAC 8 Mar 2018 PRAC signal: Stress cardiomyopathy
Action for MAH: update of the product information: Yes

All safety entries for norepinephrine →

Combinations containing Norepinephrine

Articaine + norepinephrine

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.