MedPath

Morphine

Generic Name
Morphine
Brand Names
Arymo, Avinza, Doloral, Duramorph, Embeda, Infumorph, Kadian, M-ediat, M-eslon, MSIR, Mitigo, Ms Contin, Statex
Drug Type
Small Molecule
Chemical Formula
C17H19NO3
CAS Number
57-27-2
Unique Ingredient Identifier
76I7G6D29C

Overview

Morphine, the main alkaloid of opium, was first obtained from poppy seeds in 1805. It is a potent analgesic, though its use is limited due to tolerance, withdrawal, and the risk of abuse. Morphine is still routinely used today, though there are a number of semi-synthetic opioids of varying strength such as codeine, fentanyl, methadone, hydrocodone, hydromorphone, meperidine, and oxycodone. Morphine was granted FDA approval in 1941.

Indication

Morphine is used for the management of chronic, moderate to severe pain. Opiods, including morphine, are effective for the short term management of pain. Patients taking opioids long term may need to be monitored for the development of physical dependence, addiction disorder, and drug abuse.

Associated Conditions

  • Chronic Pain
  • Severe Pain

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/17
Not Applicable
Not yet recruiting
Ondokuz Mayıs University
2025/08/05
Not Applicable
Not yet recruiting
Papa Giovanni XXIII Hospital
2025/07/22
Not Applicable
Not yet recruiting
GCS Ramsay Santé pour l'Enseignement et la Recherche
2025/07/17
Not Applicable
Recruiting
2025/07/08
Not Applicable
Recruiting
2025/07/03
Not Applicable
Recruiting
2025/06/17
Not Applicable
Recruiting
The Second Hospital of Anhui Medical University
2025/06/17
Not Applicable
Recruiting
2025/06/10
Not Applicable
Completed
2025/06/04
Not Applicable
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Rhodes Pharmaceuticals L.P.
42858-515
ORAL
15 mg in 1 1
12/27/2023
Bryant Ranch Prepack
63629-1091
ORAL
200 mg in 1 1
10/31/2019
Quality Care Products LLC
49999-848
ORAL
15 mg in 1 1
1/6/2020
Cantrell Drug Company
52533-059
INTRAVENOUS
1 mg in 1 mL
10/20/2014
Bryant Ranch Prepack
71335-0707
ORAL
60 mg in 1 1
7/30/2025
Hikma Pharmaceuticals USA Inc.
0054-0235
ORAL
15 mg in 1 1
9/1/2018
Hospira, Inc.
0409-1890
INTRAVENOUS
2 mg in 1 mL
7/30/2025
STAT RX USA LLC
16590-697
ORAL
20 mg in 1 1
6/15/2011
Bryant Ranch Prepack
63629-1965
ORAL
10 g in 1000 mL
2/8/2021
Upsher-Smith Laboratories, LLC
0832-0225
ORAL
10 mg in 1 1
2/29/2024

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
MST CONTINUS TABLET 10 mg
SIN05506P
TABLET, FILM COATED
10 mg
3/4/1991
MORPHINE SULFATE KALCEKS SOLUTION FOR INJECTION 10MG/ML
SIN16891P
INJECTION, SOLUTION
10.00mg/mL
10/20/2023
DBL MORPHINE SULFATE INJECTION BP 10 mg/ml
SIN00757P
INJECTION
10 mg/ml
5/4/1988
ORAMORPH SYRUP 2MG/ML
SIN16036P
SYRUP
2MG/ML
10/30/2020
Morphine-hameln 10 mg/ml Injection
SIN13598P
INJECTION, SOLUTION
10mg
2/9/2009
SOOV CREAM
SIN08901P
CREAM
1.00% w/w
9/4/1996
MST CONTINUS TABLET 30 mg
SIN05508P
TABLET, FILM COATED
30 mg
3/4/1991

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
SANDOZ MORPHINE SR
02244791
Tablet (Extended-Release) - Oral
30 MG
11/14/2001
MORPHINE SULFATE INJECTION USP
02242484
Liquid - Intramuscular ,  Intravenous ,  Subcutaneous
2 MG / ML
12/12/2000
PMS-MORPHINE SULFATE SR 100 MG
02245287
Tablet (Extended-Release) - Oral
100 MG
12/17/2007
MORPHINE SULFATE INJECTION, USP
fresenius kabi canada ltd
02488647
Solution - Intramuscular ,  Intravenous ,  Subcutaneous
10 MG / 1 ML
N/A
DOLORAL SIROP
laboratoire atlas inc
00614505
Syrup - Oral
5 MG / ML
12/31/1991
KADIAN
BGP Pharma ULC
02184451
Capsule (Sustained-Release) - Oral
100 MG
10/25/1996
SANDOZ MORPHINE SR
02478889
Tablet (Extended-Release) - Oral
100 MG
12/19/2018
PMS-MORPHINE SULFATE IR
02549743
Tablet (Immediate Release) - Oral
5 MG
N/A
MORPHINE SULFATE INJECTION, USP
fresenius kabi canada ltd
02488620
Solution - Subcutaneous ,  Intramuscular ,  Intravenous
2 MG / 1 ML
N/A
MORPHINE SULFATE INJECTION BP
Sterimax Inc
02474999
Solution - Intramuscular ,  Intravenous ,  Subcutaneous
15 MG / ML
N/A

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
MORFINA KALCEKS 10 MG/ML SOLUCION INYECTABLE EFG
Kalceks As
82883
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Estupefacientes
Not Commercialized
MORFINA SERRA 20 MG/ML SOLUCION INYECTABLE
Laboratorios Serra Pamies S.A.
37472
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Estupefacientes
Commercialized
MORFINA SERRA 10 MG/ML SOLUCION INYECTABLE
Laboratorios Serra Pamies S.A.
37473
SOLUCIÓN INYECTABLE
Medicamento Sujeto A Prescripción Médica. Estupefacientes
Commercialized
DROPIZOL 10 MG/ML GOTAS ORALES EN SOLUCION
Pharmanovia A/S
83323
GOTAS ORALES EN SOLUCIÓN
Diagnóstico Hospitalario. Estupefacientes
Commercialized
MARACEX 20 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION
Kalceks As
84129
SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN
Medicamento Sujeto A Prescripción Médica. Estupefacientes
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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