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

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Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/08
Phase 2
Active, not recruiting
2024/10/22
Not Applicable
Completed
Ondokuz Mayıs University
2024/10/01
Early Phase 1
Recruiting
2024/08/27
Not Applicable
Recruiting
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
2024/08/26
Phase 4
Not yet recruiting
2024/08/20
Not Applicable
ENROLLING_BY_INVITATION
2024/06/28
Phase 4
Not yet recruiting
2024/06/21
Phase 2
Recruiting
2024/06/18
Phase 3
Recruiting
2024/06/13
Phase 4
Completed
Yuwei Qiu

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Bryant Ranch Prepack
63629-2302
ORAL
20 mg in 1 mL
1/6/2022
Sun Pharmaceutical Industries, Inc.
63304-451
ORAL
30 mg in 1 1
12/14/2023
Fresenius Kabi USA, LLC
76045-005
INTRAVENOUS, INTRAMUSCULAR
4 mg in 1 mL
8/31/2020
Piramal Critical Care, Inc.
66794-162
EPIDURAL, INTRATHECAL
500 mg in 20 mL
7/23/2025
Par Pharmaceutical Inc.
49884-670
ORAL
100 mg in 1 1
2/19/2015
Precision Dose, Inc.
68094-256
ORAL
100 mg in 5 mL
6/30/2023
Rhodes Pharmaceuticals L. P.
42858-802
ORAL
30 mg in 1 1
12/31/2023
Physicians Total Care, Inc.
54868-5590
ORAL
100 mg in 1 1
3/7/2011
Purdue Pharma LP
59011-262
ORAL
60 mg in 1 1
3/23/2017
Hospira, Inc.
0409-1134
INTRAVENOUS
50 mg in 1 mL
10/13/2021

EMA Drug Approvals

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

HSA Drug Approvals

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Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
M.O.S. SYRUP 1.0 MG/ML
valeant canada lp / valeant canada s.e.c.
00486582
Syrup - Oral
1 MG / ML
12/31/1980
M.O.S.-50 CONCENTRATE LIQ 50MG/ML
valeant canada lp / valeant canada s.e.c.
00690236
Syrup - Oral
50 MG / ML
12/31/1986
M.O.S. 20 CONCENTRATE 20MG/ML
valeant canada lp / valeant canada s.e.c.
00632481
Syrup - Oral
20 MG / ML
12/31/1985
M-EDIAT
02320436
Capsule (Immediate Release) - Oral
20 MG
9/6/2016
MS CONTIN
purdue pharma
02014327
Tablet (Extended-Release) - Oral
200 MG
12/31/1993
MORPHINE SULFATE INJECTION SDZ
02382970
Solution - Intramuscular ,  Intravenous ,  Subcutaneous
1 MG / ML
N/A
MS CONTIN
purdue pharma
02015439
Tablet (Extended-Release) - Oral
15 MG
12/31/1993
NTP-MORPHINE SR
teva canada limited
02346370
Tablet (Extended-Release) - Oral
30 MG
N/A
MORPHINE SULPHATE INJECTION 2MG/ML
hospira healthcare ulc
02137240
Liquid - Subcutaneous ,  Intravenous
2 MG / ML
9/4/1997
TEVA-MORPHINE SR
teva canada limited
02302780
Tablet (Extended-Release) - Oral
60 MG
4/1/2008

CIMA AEMPS Drug Approvals

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Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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

Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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

UK EMC Drug Information

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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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