Regulatory PathRegulatory requirements compared

Active substance

Salbutamol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ASMADIL SYRUP0.4 mg/mlSyrup · Oral use1 BottleSAR 4.40Generic · PrescriptionAPMValid
ASMADIL TABS 2MG2 mgTablet · Oral use30 BlisterSAR 3.40Generic · PrescriptionAPMValid
BRONCHOVENT 5mg/ml nebuliser solution5 mg/mlNebuliser solution · Inhalation use1 VialSAR 12.50Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
BUTALIN 0.5% SOLUTION FOR NEBULISER0.5 %Nebuliser solution · Inhalation use1 BottleSAR 14.60Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
BUTALIN 100MCG-DOSE INHALER100 µgPressurised inhalation · Inhalation use1 InhalerSAR 14.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
BUTALIN 2 mg tablet2 mgTablet · Oral use20 BlisterSAR 6.15Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
BUTALIN SYRUP 2MG-5ML0.4 mg/mlSyrup · Oral use1 BottleSAR 10.35Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
BUTALIN TABS 4MG4 mgTablet · Oral use20 BlisterSAR 8.30Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
Bronchovent5 mg/mlinhalation solution · Inhalation use50 VialSAR 548.15Generic · PrescriptionPharmaceutical Solutions Industry LtdValid
FARCOLIN 0.5% RESPIRATOR Solution0.5 %Nebuliser solution · Inhalation use1 InhalerSAR 12.50Generic · PrescriptionPHARCO PHARMACEUTICALValid
LERHASA100 µgPressurised inhalation, suspension · Inhalation use1 InhalerSAR 14.50Generic · PrescriptionALPHA PHARMA INDUSTRYValid
SALBULASE 2MG-5ML SYRUP0.4 mg/mlSyrup · Oral use1 BottleSAR 6.70Generic · PrescriptionKUWAIT SAUDI PHARMACEUTICAL INDUSTRIESValid
VENTOLIN0.4 mg/mlSyrup · Oral use1 BottleSAR 8.35Generic · PrescriptionGLAXO SAUDI ARABIAValid
VENTOLIN 0.5MG\ML INJ0.5 mg/mlSolution for injection · Intravenous use5 AmpouleSAR 17.45Generic · PrescriptionGlaxo Saudi Arabia Ltd.Valid
VENTOLIN EVOHALER100 µgPressurised inhalation, solution · Inhalation use1 InhalerSAR 18.75NCE · PrescriptionGLAXO SAUDI ARABIAValid
VENTOLIN RESPIRATORY SOLUTIN0.5 %Nebuliser solution · Inhalation use1 BottleSAR 18.65Generic · PrescriptionGLAXO SAUDI ARABIAValid
NEOVENTIL 2MG-5ML SYRUP0.4 mg/mlSyrup · Oral use1 BottleSAR 3.10Generic · PrescriptionNEOPHARMASuspended
AIROMIR INHALER 100MCG-ACTUATION100 µgPressurised inhalation, solution · Inhalation use1 InhalerSAR 13.40Generic · Prescription3MWithdrawn by MAH · Not Marketed
ASMANORE SYRUP 2MG-5ML0.4 mg/mlSyrup · Oral use1 BottleSAR 2.55NCE · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
ASMANORE TAB 4MG4 mgTablet · Oral use30 BlisterSAR 3.10NCE · PrescriptionThe Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)Withdrawn by MAH · Not Marketed
ASTHAVENT 2MG/5ML SYRUP0.4 mg/mlSyrup · Oral use1 BottleSAR 3.95Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
BUTOVENT 100MCG SPRAY PUFF INHALER100 µgPressurised inhalation, solution · Inhalation use1 InhalerSAR 12.70Generic · PrescriptionCHIESI FARMACEUTICISWithdrawn by MAH · Not Marketed
DISBRON SYRUP 2MG-5ML0.4 mg/mlSyrup · Oral use1 BottleSAR 7.35Generic · PrescriptionFERRER INTERNATIONALWithdrawn by MAH · Not Marketed
SALAMAT 2 MG - 5 ML ( 145 ML )0.4 mg/mlSyrup · Oral use1 BottleSAR 4.60Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
SALAMAT 2MG TABLET2 mgTablet · Oral use30 BlisterSAR 3.30Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed

18 more — full table

Indications — CHI Daman Drug Formulary

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); SICKLE CELL DISEASE - ACS MANAGEMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
ALBUTEROL SULFATEEQ 4MG BASE; EQ 2MG BASEtablet · oralSUN PHARM INDUSTRIESPrescription1 Feb 1989
ALBUTEROL SULFATEEQ 2MG BASE/5MLsyrup · oralTEVAPrescription30 Mar 1992
PROVENTIL-HFAEQ 0.09MG BASE/INHaerosol, metered · inhalationKINDEVAPrescription15 Aug 1996
ALBUTEROL SULFATEEQ 0.083% BASEsolution · inhalationNEPHRONPrescription17 Sep 1997
ALBUTEROL SULFATEEQ 0.5% BASEsolution · inhalationSENTISSPrescription15 Jan 1998
VENTOLIN HFAEQ 0.09MG BASE/INHaerosol, metered · inhalationGLAXOSMITHKLINEPrescription19 Apr 2001
ALBUTEROL SULFATEEQ 0.5% BASEsolution · inhalationNEPHRONPrescription26 Jun 2001
ALBUTEROL SULFATEEQ 0.042% BASE; EQ 0.021% BASEsolution · inhalationNEPHRONPrescription28 Jun 2004
PROAIR HFAEQ 0.09MG BASE/INHaerosol, metered · inhalationTEVA BRANDED PHARMPrescription29 Oct 2004
ALBUTEROL SULFATEEQ 2MG BASE/5MLsyrup · oralCHARTWELL MOLECULARPrescription27 Dec 2006
ALBUTEROL SULFATEEQ 2MG BASE/5MLsyrup · oralCHARTWELL RXPrescription26 Jun 2007
ALBUTEROL SULFATEEQ 0.083% BASEsolution · inhalationRITEDOSE CORPPrescription16 Dec 2008
ALBUTEROL SULFATEEQ 2MG BASE/5MLsyrup · oralAMNEAL PHARMSPrescription12 May 2010
PROAIR RESPICLICKEQ 0.09MG BASE/INHpowder, metered · inhalationTEVA BRANDED PHARMPrescription31 Mar 2015
ALBUTEROL SULFATEEQ 0.083% BASEsolution · inhalationSUN PHARMPrescription21 Jul 2017
ALBUTEROL SULFATEEQ 0.083% BASEsolution · inhalationLUOXIN AUROVITASPrescription17 Oct 2017
ALBUTEROL SULFATEEQ 2MG BASE; EQ 4MG BASEtablet · oralAMNEAL PHARMS COPrescription21 May 2018
ALBUTEROL SULFATEEQ 2MG BASE; EQ 4MG BASEtablet · oralRISINGPrescription29 Jun 2018
ALBUTEROL SULFATEEQ 2MG BASE; EQ 4MG BASEtablet · oralACERTIS PHARMSPrescription26 Oct 2018
ALBUTEROL SULFATEEQ 2MG BASE/5MLsyrup · oralQUAGENPrescription6 Sep 2019
ALBUTEROL SULFATEEQ 0.09MG BASE/INHaerosol, metered · inhalationPADAGIS USPrescription24 Feb 2020
ALBUTEROL SULFATEEQ 0.09MG BASE/INHaerosol, metered · inhalationCIPLAPrescription8 Apr 2020
ALBUTEROL SULFATEEQ 0.021% BASE; EQ 0.042% BASEsolution · inhalationLUOXIN AUROVITASPrescription20 Apr 2020
ALBUTEROL SULFATEEQ 0.09MG BASE/INHaerosol, metered · inhalationLUPINPrescription24 Aug 2020
ALBUTEROL SULFATEEQ 2MG BASE; EQ 4MG BASEtablet · oralZYDUS PHARMSPrescription22 Oct 2020

75 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-SALBUTAMOL HFA02245669100 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONAPOTEX INC
PMS-SALBUTAMOL022082291 MG / MLSOLUTION · INHALATIONPHARMASCIENCE INC
PMS-SALBUTAMOL022082372 MG / MLSOLUTION · INHALATIONPHARMASCIENCE INC
PMS-SALBUTAMOL022082450.5 MG / MLSOLUTION · INHALATIONPHARMASCIENCE INC
SALBUTAMOL HFA02419858100 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONSANIS HEALTH INC
TEVA-SALBUTAMOL HFA02326450100 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONTEVA CANADA LIMITED
TEVA-SALBUTAMOL STERINEBS P.F.019269341 MG / MLSOLUTION · INHALATIONTEVA CANADA LIMITED
TEVA-SALBUTAMOL STERINEBS P.F.021733602 MG / MLSOLUTION · INHALATIONTEVA CANADA LIMITED
VENTOLIN DISKUS02243115200 MCG / ACTPOWDER · INHALATIONGLAXOSMITHKLINE INC
VENTOLIN HFA02241497100 MCG / ACTAEROSOL (METERED-DOSE) · INHALATIONGLAXOSMITHKLINE INC
VENTOLIN I.V. INFUSION SOLUTION 5.0MG SALBUTAMOL IN 5ML (1000MCG/ML)022134511 MG / MLSOLUTION · INTRAVENOUSGLAXOSMITHKLINE INC
VENTOLIN RESPIRATOR SOLUTION022134865 MG / MLSOLUTION · INHALATIONGLAXOSMITHKLINE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACALBUTEROL 2.5 MG/0.5 ML SOL$0.51582per EA23 Sep 2026
US NADACALBUTEROL HFA 90 MCG INHALER$2.12002per GM23 Sep 2026
US NADACALBUTEROL HFA 90 MCG INHALER$1.54049per GM23 Sep 2026
US NADACALBUTEROL HFA 90 MCG INHALER$1.82548per GM23 Sep 2026
US NADACALBUTEROL SUL 0.63 MG/3 ML SOL$0.19407per ML23 Sep 2026
US NADACALBUTEROL SUL 0.63 MG/3 ML SOL$0.25227per ML23 Sep 2026
US NADACALBUTEROL SUL 1.25 MG/3 ML SOL$0.1979per ML23 Sep 2026
US NADACALBUTEROL SUL 1.25 MG/3 ML SOL$0.22622per ML23 Sep 2026
US NADACALBUTEROL SUL 2.5 MG/3 ML SOLN$0.06044per ML23 Sep 2026
US NADACALBUTEROL SUL 2.5 MG/3 ML SOLN$0.06125per ML23 Sep 2026
US NADACALBUTEROL SUL 2.5 MG/3 ML SOLN$0.06651per ML23 Sep 2026
US NADACALBUTEROL SULF 2 MG/5 ML SYRUP$0.03176per ML23 Sep 2026
NHS Drug TariffSalbutamol 100micrograms/dose breath actuated inhaler CFC free£6.30200 dose1 Oct 2026
NHS Drug TariffSalbutamol 100micrograms/dose dry powder inhalation cartridge£2.75200 dose1 Oct 2026
NHS Drug TariffSalbutamol 100micrograms/dose dry powder inhalation cartridge with device£4.95200 dose1 Oct 2026
NHS Drug TariffSalbutamol 100micrograms/dose dry powder inhaler£4.05200 dose1 Oct 2026
NHS Drug TariffSalbutamol 100micrograms/dose inhaler CFC free£1.50200 dose1 Oct 2026
NHS Drug TariffSalbutamol 2.5mg/2.5ml nebuliser liquid unit dose ampoules£16.2520 unit dose1 Oct 2026
NHS Drug TariffSalbutamol 200micrograms/dose dry powder inhaler£3.6060 dose1 Oct 2026
NHS Drug TariffSalbutamol 200micrograms/dose dry powder inhaler£8.12200 dose1 Oct 2026
NHS Drug TariffSalbutamol 2mg tablets£109.4728 tablet1 Oct 2026
NHS Drug TariffSalbutamol 2mg/5ml oral solution sugar free£1.50150 ml1 Oct 2026
NHS Drug TariffSalbutamol 4mg tablets£107.8628 tablet1 Oct 2026
NHS Drug TariffSalbutamol 500micrograms/1ml solution for injection ampoules£1.915 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.

WHO WHO Model List of Essential Medicines (2025)

  • 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
    Chronic obstructive pulmonary disease; Asthma
    Parenteral > General injections > IV: 500 µg per mL in 1 mL ampoule (as sulfate); 500 µg per mL in 5 mL ampoule (as sulfate) | Respiratory > Inhalation > solution: 100 µg per actuation in pressurized metered dose inhaler (as sulfate); 2.5 mg per 2.5 mL in 2.5 mL ampoule (as sulfate) for use in nebulizers; 5 mg per 2.5 mL in 2.5 mL ampoule (as sulfate) for use in nebulizers; 5 mg per mL in multi-dose bottle (as sulfate) for use in nebulizers

Safety signals and safety-related labeling changes

All safety entries for salbutamol →

Combinations containing Salbutamol

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.