Is Terbutaline registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Terbutaline, including BRONCLYN 1.5MG-5ML SYRUP (0.3 mg/ml, Syrup, SAR 5.60); DILANYL SYRUP (0.3 mg/ml, Syrup, SAR 10.35).

Is Terbutaline approved by the US FDA?

Drugs@FDA lists 15 application product lines for Terbutaline, including BRETHINE (Prescription); TERBUTALINE SULFATE (Prescription); TERBUTALINE SULFATE (Prescription); TERBUTALINE SULFATE (Prescription); TERBUTALINE SULFATE (Prescription).

Is Terbutaline on the WHO Model List of Essential Medicines?

Yes — 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease (core list): Therapeutic equivalent to salbutamol for Chronic obstructive pulmonary disease; Therapeutic equivalent to salbutamol for Asthma.

Active substance

Terbutaline

SFDA 9
US FDA 15
Health Canada 1
US price lines 2
NHS prices 3
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
BRONCLYN 1.5MG-5ML SYRUP	0.3 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.60	Generic · Prescription	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Valid
DILANYL SYRUP	0.3 mg/ml	Syrup · Oral use	1 Bag	SAR 10.35	Generic · Prescription	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
BRICANYL 2.5MG-ML SOLN.FOR NEBULISATION	2.5 mg/ml	Solution · Inhalation use	20 Ampoule	SAR 20.65	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
BRICANYL AMP.	0.5 mg/ml	Solution · Intravenous use	10 Ampoule	SAR 20.60	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
BRICANYL SYP	0.3 mg/ml	Syrup · Oral use	1 Bottle	SAR 10.50	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
BRICANYL TAB 5MG	5 mg	Capsule · Oral use	30 Blister	SAR 12.15	NCE · Prescription	AstraZeneca	Withdrawn by regulatory authority · Not Marketed
BRICANYL TURBUHALER 0.5MG-DOSE	0.5 mg	Solution · Inhalation use	1 Inhaler	SAR 46.95	NCE · Prescription	AstraZeneca	Withdrawn by MAH · Not Marketed
NEOTERB 1.5MG-5ML ORAL SYRUP	0.3 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.05	Generic · Prescription	NEOPHARMA	Suspended · Not Marketed
TALIN 1.5MG-5ML SYRUP	0.3 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.45	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE EXACERBATION OF BRONCHIECTASIS (NON-CYSTIC FIBROSIS); ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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

Product	Strength	Form · route	Applicant	Status	First approved
BRETHINE	2.5MG; 5MG	tablet · oral	ANI PHARMS	Prescription	17 May 1976
TERBUTALINE SULFATE	2.5MG; 5MG	tablet · oral	IMPAX LABS	Prescription	26 Jun 2001
TERBUTALINE SULFATE	1MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	26 May 2004
TERBUTALINE SULFATE	2.5MG; 5MG	tablet · oral	LANNETT CO INC	Prescription	25 Mar 2005
TERBUTALINE SULFATE	1MG/ML	injectable · injection	HIKMA FARMACEUTICA	Prescription	20 May 2009
TERBUTALINE SULFATE	1MG/ML	injectable · injection	AREVA PHARMS	Prescription	8 Nov 2013
BRICANYL	1MG/ML	injectable · injection	SANOFI AVENTIS US	Discontinued	25 Mar 1974
BRICANYL	2.5MG; 5MG	tablet · oral	SANOFI AVENTIS US	Discontinued	22 Apr 1975
BRETHINE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	PHARMACARE	Discontinued	30 Nov 1981
BRICANYL	0.2MG/INH	aerosol, metered · inhalation	SANOFI AVENTIS US	Discontinued	19 Mar 1985
TERBUTALINE SULFATE	1MG/ML	injectable · injection	CHARTWELL INJECTABLE	Discontinued	23 Apr 2004
TERBUTALINE SULFATE	1MG/ML	injectable · injection	DR REDDYS	Discontinued	20 Jul 2004
TERBUTALINE SULFATE	1MG/ML	injectable · injection	EPIC PHARMA LLC	Discontinued	7 Jan 2008
TERBUTALINE SULFATE	2.5MG; 5MG	tablet · oral	TWI PHARMS	Discontinued	19 Jun 2020
BRETHAIRE	0.2MG/INH	aerosol, metered · inhalation	NOVARTIS	Discontinued

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BRICANYL TURBUHALER	00786616	0.5 MG / DOSE	POWDER · INHALATION	ASTRAZENECA CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TERBUTALINE SULFATE 2.5 MG TAB	$0.94675	per EA	23 Sep 2026
US NADAC	TERBUTALINE SULFATE 5 MG TAB	$0.63772	per EA	23 Sep 2026
NHS Drug Tariff	Terbutaline 2.5mg/5ml solution for injection ampoules	£20.09	10 ampoule	1 Oct 2026
NHS Drug Tariff	Terbutaline 500micrograms/dose dry powder inhaler	£8.30	120 dose	1 Oct 2026
NHS Drug Tariff	Terbutaline 5mg/2ml nebuliser liquid unit dose vials	£11.64	20 unit dose	1 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)

25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Therapeutic equivalent to salbutamol for Chronic obstructive pulmonary disease; Therapeutic equivalent to salbutamol for Asthma

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.