Regulatory PathRegulatory requirements compared

Active substance

Morphine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MORPHINE HCl10 mg/mlSolution for injection · Intrathecal, Intravenous, Intramuscular10 AmpouleSAR 197.50NCE · PrescriptionLABORATOIRES STEROP NVValid
MORPHINE SULPHATE BP 10 mg/ml solution for injection10 mg/mlSolution for injection · Parenteral use10 AmpouleSAR 34.85Generic · PrescriptionMACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALSValid
MST Continus 10 mg10 mgProlonged-release tablet · Oral use60 BlisterSAR 47.05NCE · PrescriptionMUNDIPHARMA MEDICAL COMPANYValid
MST Continus 30 mg30 mgProlonged-release tablet · Oral use60 BlisterSAR 116.20NCE · PrescriptionMUNDIPHARMA MEDICAL COMPANYValid
MST Continus 60 mg60 mgProlonged-release tablet · Oral use60 BlisterSAR 218.90NCE · PrescriptionMUNDIPHARMA MEDICAL COMPANYValid
Morphine HCL Kabi10 mg/mlSolution for injection · Intravenous use10 AmpouleSAR 197.50NCE · PrescriptionLabesfal Laboratorios Almiro, S.A.Valid
Morphine sulfate 10 mg per 5 ml2 mg/mlOral solution · Oral use1 BottleSAR 28.65Generic · PrescriptionMartindale PharmaValid
Morphine sulfate Kalceks10 mg/mlSolution for injection · Intramuscular and intravenous use10 AmpouleSAR 51.00Generic · PrescriptionAS KalceksValid
Oramorph20 mg/mlOral solution · Oral use1 Dropper ContainerSAR 30.35NCE · PrescriptionL Molteni and C dei F lli Alitti Societa di Esercizio SpAValid
VERMOR-10MG/ML SOLUTION FOR INJECTION10 mg/mlSolution for injection · Intramuscular and intravenous use10 AmpouleSAR 40.70Generic · PrescriptionVERVE HUMAN CARE LABORATORIESWithdrawn by MAH · Not Marketed
VERMOR-15MG/ML SOLUTION FOR INJECTION15 mg/mlSolution for injection · Intramuscular and intravenous use10 AmpouleSAR 40.70Generic · PrescriptionVERVE HUMAN CARE LABORATORIESWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BURN MANAGEMENT; ENDOMETRIOSIS; SICKLE CELL DISEASE - PAIN MANAGEMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
DURAMORPH PF0.5MG/ML; 1MG/MLinjectable · injectionHIKMA PHARMSPrescription18 Sep 1984
INFUMORPH10MG/ML; 25MG/MLinjectable · injectionHIKMA PHARMSPrescription18 Sep 1984
MS CONTIN30MG; 60MG; 15MGtablet, extended release · oralKNOA PHARMAPrescription29 May 1987
MORPHINE SULFATE0.5MG/MLinjectable · injectionHOSPIRAPrescription30 Sep 1992
MORPHINE SULFATE1MG/MLinjectable · injectionHOSPIRAPrescription30 Sep 1992
MORPHINE SULFATE100MG; 200MGtablet, extended release · oralRHODES PHARMSPrescription2 Jul 1998
MORPHINE SULFATE15MG; 30MG; 60MGtablet, extended release · oralRHODES PHARMSPrescription7 Jul 1998
MORPHINE SULFATE15MGtablet, extended release · oralDAVA PHARMS INCPrescription28 Jan 2000
MORPHINE SULFATE100MG; 200MGtablet, extended release · oralSPECGX LLCPrescription3 Jul 2003
MORPHINE SULFATE15MG; 30MG; 60MGtablet, extended release · oralSPECGX LLCPrescription31 Jul 2003
MORPHINE SULFATE10MG/5ML; 20MG/5ML; 100MG/5MLsolution · oralHIKMA PHARMSPrescription17 Mar 2008
MORPHINE SULFATE15MG; 30MGtablet · oralHIKMA PHARMSPrescription17 Mar 2008
MORPHINE SULFATE100MG/5MLsolution · oralSPECGX LLCPrescription15 Jul 2011
MORPHINE SULFATE2MG/ML; 4MG/ML; 8MG/ML; 10MG/ML; 50MG/MLinjectable · injectionHOSPIRA INCPrescription14 Nov 2011
MORPHINE SULFATE15MG; 30MG; 60MG; 100MG; 200MGtablet, extended release · oralSUN PHARM INDS LTDPrescription11 May 2012
MORPHINE SULFATE30MG; 45MG; 60MG; 75MG; 90MG; 120MGcapsule, extended release · oralACTAVIS ELIZABETHPrescription16 Jan 2013
MORPHINE SULFATE10MG; 20MG; 30MG; 50MG; 60MG; 80MG; 100MGcapsule, extended release · oralUPSHER SMITH LABSPrescription3 Jun 2013
MORPHINE SULFATE2MG/ML (2MG/ML); 4MG/ML (4MG/ML); 10MG/ML (10MG/ML)solution · intramuscular, intravenousFRESENIUS KABI USAPrescription30 Oct 2013
MORPHINE SULFATE100MG/5MLsolution · oralTRIS PHARMA INCPrescription12 May 2015
MORPHINE SULFATE4MG/ML; 8MG/ML; 10MG/MLinjectable · injectionHIKMA PHARMSPrescription21 May 2015
MORPHINE SULFATE100MG/5ML; 10MG/5MLsolution · oralPHARM ASSOCPrescription14 Nov 2016
MITIGO10MG/ML; 25MG/MLinjectable · injectionPIRAMAL CRITICALPrescription16 Jul 2018
MORPHINE SULFATE15MG; 30MGtablet · oralUPSHER SMITH LABSPrescription22 Jul 2019
MORPHINE SULFATE15MG; 30MGtablet · oralALKEM LABS LTDPrescription3 Dec 2020
MORPHINE SULFATE10MG/5ML; 20MG/5ML; 100MG/5MLsolution · oralWINDER LABS LLCPrescription12 Feb 2021

56 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
DOLORAL SIROP006144911 MG / MLSYRUP · ORALLABORATOIRE ATLAS INC
DOLORAL SIROP006145055 MG / MLSYRUP · ORALLABORATOIRE ATLAS INC
KADIAN0218443520 MGCAPSULE (EXTENDED-RELEASE) · ORALBGP PHARMA ULC
KADIAN0218444350 MGCAPSULE (EXTENDED-RELEASE) · ORALBGP PHARMA ULC
KADIAN02184451100 MGCAPSULE (EXTENDED-RELEASE) · ORALBGP PHARMA ULC
KADIAN0224216310 MGCAPSULE (EXTENDED-RELEASE) · ORALBGP PHARMA ULC
KADIAN02559722200 MGCAPSULE (EXTENDED-RELEASE) · ORALBGP PHARMA ULC
M-EDIAT023203985 MGCAPSULE (IMMEDIATE-RELEASE) · ORALETHYPHARM INC
M-EDIAT0232042810 MGCAPSULE (IMMEDIATE-RELEASE) · ORALETHYPHARM INC
M-EDIAT0232043620 MGCAPSULE (IMMEDIATE-RELEASE) · ORALETHYPHARM INC
M-EDIAT0232044430 MGCAPSULE (IMMEDIATE-RELEASE) · ORALETHYPHARM INC
M-ESLON0201993010 MGCAPSULE (EXTENDED-RELEASE) · ORALETHYPHARM INC
M-ESLON0201994930 MGCAPSULE (EXTENDED-RELEASE) · ORALETHYPHARM INC
M-ESLON0201995760 MGCAPSULE (EXTENDED-RELEASE) · ORALETHYPHARM INC
M-ESLON02019965100 MGCAPSULE (EXTENDED-RELEASE) · ORALETHYPHARM INC
M-ESLON0217774915 MGCAPSULE (EXTENDED-RELEASE) · ORALETHYPHARM INC
M-ESLON02177757200 MGCAPSULE (EXTENDED-RELEASE) · ORALETHYPHARM INC
MORPHINE HP 500061728850 MG / MLSOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUSSANDOZ CANADA INCORPORATED
MORPHINE LP EPIDURAL020210481 MG / MLSOLUTION · EPIDURAL; INTRAVENOUS; SUBCUTANEOUSSANDOZ CANADA INCORPORATED
MORPHINE LP EPIDURAL020210560.5 MG / MLSOLUTION · EPIDURAL; INTRAVENOUS; SUBCUTANEOUSSANDOZ CANADA INCORPORATED
MORPHINE SULFATE INJ 10MG/ML USP0039258810 MG / MLSOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUSSANDOZ CANADA INCORPORATED
MORPHINE SULFATE INJ 15MG/ML USP0039256115 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUSSANDOZ CANADA INCORPORATED
MORPHINE SULFATE INJECTION025007012 MG / MLSOLUTION · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUSJAMP PHARMA CORPORATION
MORPHINE SULFATE INJECTION0250072810 MG / MLSOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULARJAMP PHARMA CORPORATION
MORPHINE SULFATE INJECTION0250073615 MG / MLSOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULARJAMP PHARMA CORPORATION

31 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACMORPHINE SULF 10 MG/5 ML SOLN$0.09151per ML23 Sep 2026
US NADACMORPHINE SULF 10 MG/5 ML SOLN$0.0431per ML23 Sep 2026
US NADACMORPHINE SULF 100 MG/5 ML CONC$0.45992per ML23 Sep 2026
US NADACMORPHINE SULF 100 MG/5 ML CONC$0.39203per ML23 Sep 2026
US NADACMORPHINE SULF 100 MG/5 ML CONC$0.30191per ML23 Sep 2026
US NADACMORPHINE SULF 20 MG/5 ML SOLN$0.11959per ML23 Sep 2026
US NADACMORPHINE SULF ER 100 MG TABLET$0.85389per EA23 Sep 2026
US NADACMORPHINE SULF ER 15 MG TABLET$0.30984per EA23 Sep 2026
US NADACMORPHINE SULF ER 200 MG TABLET$2.12665per EA23 Sep 2026
US NADACMORPHINE SULF ER 30 MG TABLET$0.44128per EA23 Sep 2026
US NADACMORPHINE SULF ER 60 MG TABLET$0.65658per EA23 Sep 2026
US NADACMORPHINE SULFATE 10 MG/ML VIAL$2.34224per ML19 Aug 2026
NHS Drug TariffMorphine 100mg modified-release capsules£21.8060 capsule1 Oct 2026
NHS Drug TariffMorphine 100mg modified-release tablets£38.5060 tablet1 Oct 2026
NHS Drug TariffMorphine 10mg modified-release capsules£3.4760 capsule1 Oct 2026
NHS Drug TariffMorphine 10mg modified-release tablets£5.2060 tablet1 Oct 2026
NHS Drug TariffMorphine 10mg orodispersible tablets sugar free£7.7556 tablet1 Oct 2026
NHS Drug TariffMorphine 10mg tablets£5.3156 tablet1 Oct 2026
NHS Drug TariffMorphine 120mg modified-release capsules£29.1528 capsule1 Oct 2026
NHS Drug TariffMorphine 150mg modified-release capsules£36.4328 capsule1 Oct 2026
NHS Drug TariffMorphine 15mg modified-release tablets£9.1060 tablet1 Oct 2026
NHS Drug TariffMorphine 1mg orodispersible tablets sugar free£4.7556 tablet1 Oct 2026
NHS Drug TariffMorphine 2.5mg orodispersible tablets sugar free£5.7556 tablet1 Oct 2026
NHS Drug TariffMorphine 200mg modified-release capsules£43.6060 capsule1 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)

  • 2.2. Opioid analgesics · core
    Pain
    Oral > Liquid: 5 mg per 5 mL (morphine hydrochloride or morphine sulfate) (EMLc); 10 mg per 5 mL (morphine hydrochloride or morphine sulfate) | Parenteral > General injections > unspecified: 1 mg per mL in 1 mL ampoule (morphine hydrochloride or morphine sulfate) (EMLc); 2 mg per mL in 1 mL ampoule (morphine hydrochloride or morphine sulfate) (EMLc); 10 mg per mL in 1 mL ampoule (morphine hydrochloride or morphine sulfate) | Oral > Solid > tablet: 10 mg immediate release (morphine sulfate) | Oral > Solid > dosage form: 30 mg slow-release (morphine hydrochloride or morphine sulfate); 200 mg slow-release (morphine hydrochloride or morphine sulfate) (EML); 100 mg slow-release (morphine hydrochloride or morphine sulfate); 60 mg slow-release (morphine hydrochloride or morphine sulfate); 10 mg slow-release (morphine hydrochloride or morphine sulfate); 5 mg slow-release (morphine hydrochloride or morphine sulfate) (EMLc) | Oral > Solid > granules: 20 mg (morphine sulfate); 30 mg (morphine sulfate); 60 mg (morphine sulfate); 100 mg (morphine sulfate); 200 mg (morphine sulfate) (EML)
  • 1.3. Preoperative medication and sedation for short-term procedures · core
    Opioids or related analgesics and agents affecting opioid receptors
    Parenteral > General injections > IV: 1 mg in 1 mL ampoule (morphine hydrochloride or morphine sulfate) (EMLc); 2 mg per mL in 1 mL ampoule (morphine hydrochloride or morphine sulfate) (EMLc); 10 mg per mL in 1 mL ampoule (morphine hydrochloride or morphine sulfate)

Safety signals and safety-related labeling changes

  • US FDA 22 Dec 2025 DURAMORPH PF — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 INFUMORPH — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Dec 2025 MS CONTIN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Dec 2023 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 4 Mar 2021 KADIAN — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Oct 2019 ARYMO ER — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Oct 2019 EMBEDA — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Oct 2019 MORPHABOND ER — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Oct 2019 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 7 Oct 2019 MORPHINE SULFATE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for morphine →

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.