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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
2025/02/19
Phase 3
Not yet recruiting
2025/02/14
Phase 4
Recruiting
2025/02/11
Not Applicable
Completed
2025/01/29
Phase 4
Recruiting
2025/01/20
Phase 4
Recruiting
2025/01/07
Not Applicable
Recruiting
2024/12/11
Phase 3
Recruiting
2024/12/04
Phase 4
Not yet recruiting
2024/12/04
Phase 2
Recruiting
2024/11/25
Phase 4
Not yet recruiting

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
STAT RX USA LLC
16590-597
ORAL
90 mg in 1 1
9/22/2011
Sun Pharmaceutical Industries, Inc.
63304-450
ORAL
15 mg in 1 1
12/14/2023
Purdue Pharma LP
59011-261
ORAL
30 mg in 1 1
3/23/2017
Upsher-Smith Laboratories, LLC
0832-0228
ORAL
50 mg in 1 1
2/29/2024
Fresenius Kabi USA, LLC
63323-455
INTRAVENOUS, INTRAMUSCULAR
5 mg in 1 mL
12/30/2019
Hikma Pharmaceuticals USA Inc.
0054-0517
ORAL
100 mg in 5 mL
11/15/2024
Bryant Ranch Prepack
63629-2301
ORAL
20 mg in 1 mL
1/6/2022
Padagis US LLC
0574-7114
RECTAL
20 mg in 1 1
7/8/2019
Ascend Laboratories, LLC
67877-671
ORAL
30 mg in 1 1
8/18/2021
Rhodes Pharmaceuticals L.P.
42858-631
ORAL
30 mg in 1 1
12/27/2023

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
MORPHINE EXTRA-FORTE
00869325
Solution - Intramuscular ,  Intravenous ,  Subcutaneous
50 MG / ML
12/31/1990
MORPHINE SULFATE INJECTION EPIDURAL
Sterimax Inc
02498286
Solution - Epidural
1 MG / ML
6/2/2021
MORPHINE HP 50
00617288
Solution - Intramuscular ,  Intravenous ,  Subcutaneous
50 MG / ML
12/31/1987
MORPHINE SULFATE INJECTION
02500701
Solution - Intravenous ,  Intramuscular ,  Subcutaneous
2 MG / ML
4/29/2021
MORPHINE SULFATE INJECTION
02500728
Solution - Intramuscular ,  Subcutaneous ,  Intravenous
10 MG / ML
4/29/2021
MORPHINE SULFATE INJ 10MG/ML USP
00392588
Liquid - Subcutaneous ,  Intravenous ,  Intramuscular
10 MG / ML
12/31/1978
MORPHINE SULFATE INJECTION, USP
fresenius kabi canada ltd
02482738
Solution - Subcutaneous ,  Intravenous ,  Intramuscular
8 MG / 1 ML
N/A
M-ESLON
02019965
Capsule (Extended Release) - Oral
100 MG
12/31/1993
M.O.S. 10 SYRUP 10MG/ML
valeant canada lp / valeant canada s.e.c.
00632503
Syrup - Oral
10 MG / ML
12/31/1985
ORAMORPH SR TABLETS 100MG
roxane labs, division of boehringer ingelheim
01988743
Tablet (Extended-Release) - Oral
100 MG / TAB
12/31/1992

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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