Codeine

Overview

The relief of pain (analgesia) is a primary goal for enhancing the quality of life of patients and for increasing the ability of patients to engage in day to day activities. Codeine, an opioid analgesic, was originally approved in the US in 1950 and is a drug used to decrease pain by increasing the threshold for pain without impairing consciousness or altering other sensory functions. Opiates such as codeine are derived from the poppy plant, Papaver somniferum (Papaveraceae). Codeine is utilized as a central analgesic, sedative, hypnotic, antinociceptive, and antiperistaltic agent, and is also recommended in certain diseases with incessant coughing.

Background

Indication

Codeine sulfate is a form of this drug that is commonly used. It is available in tablet form and indicated for the relief of mild to moderately severe pain, where the use of an opioid analgesic is appropriate . The solution form is used by itself or combined in a syrup with other drugs and is used as a cough suppressant in adults aged 18 and above , .

Associated Conditions

Common Cold
Cough
Flu caused by Influenza
Mild pain
Pain
Severe Pain
Dry cough
Moderate Pain
Upper respiratory symptoms

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS	2025/04/02	NCT06907355	Phase 4	Recruiting	Pontificia Universidad Catolica de Chile
Colonic Motor Patterns in Healthy Volunteers	2023/03/16	NCT05770960	Phase 4	Completed	Universitaire Ziekenhuizen KU Leuven
COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA	2022/11/23	NCT05626140	Phase 3	Completed	Pakistan Institute of Medical Sciences
Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.	2020/11/23	NCT04641338	Phase 3	Completed	Brazilian Clinical Research Institute
Codeine on Pharyngeal and Esophageal Motility	2018/12/21	NCT03784105	Phase 4	Completed	Universitaire Ziekenhuizen KU Leuven
Opioid Analgesics for Acute Fracture Pain in Adults Discharged From the ED	2018/03/27	NCT03478423	Not Applicable	Terminated	Mount Sinai Hospital, Canada
Inter- and Intra-individual Variations in Metformin Pharmacokinetics - The Importance of Genes and Drug Interactions	2017/11/07	NCT03335423	Phase 1	Completed	University of Southern Denmark
Clinical Evaluation of the VIPUN Balloon Catheter 0.1	2017/08/04	NCT03239821	Not Applicable	Completed	Universitaire Ziekenhuizen KU Leuven
Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects	2016/04/13	NCT02737059	Phase 1	Completed	Michael Camilleri
Codeine Plus Paracetamol Versus Placebo for PRK Post-operative Pain	2015/12/09	NCT02625753	Phase 3	Completed	University of Sao Paulo General Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
ACETAMINOPHEN AND CODEINE PHOSPHATE	Northwind Pharmaceuticals, LLC	51655-910	ORAL	30 mg in 1 1	6/14/2023
ACETAMINOPHEN AND CODEINE	DIRECT RX	61919-023	ORAL	30 mg in 1 1	3/29/2023
Acetaminophen and Codeine Phosphate	Physicians Total Care, Inc.	54868-0378	ORAL	12 mg in 5 mL	11/10/2010
Acetaminophen and Codeine Phosphate	Akorn	50383-338	ORAL	24 mg in 10 mL	5/25/2022
promethazine hydrochloride and codeine phosphate	Nostrum Laboratories, Inc.	70408-185	ORAL	10 mg in 5 mL	12/11/2018
Codeine sulfate	Hikma Pharmaceuticals USA Inc.	0054-0243	ORAL	15 mg in 1 1	3/15/2021
ACETAMINOPHEN AND CODEINE PHOSPHATE	A-S Medication Solutions	50090-5204	ORAL	60 mg in 1 1	5/20/2021
Promethazine/Codeine	Direct_Rx	72189-486	ORAL	10 mg in 5 mL	6/2/2023
Acetaminophen and Codeine	Blenheim Pharmacal, Inc.	10544-100	ORAL	30 mg in 1 1	12/31/2013
ACETAMINOPHEN AND CODEINE PHOSPHATE	REMEDYREPACK INC.	70518-2764	ORAL	60 mg in 1 1	3/6/2024

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
Linctus Tussis Rubra 10mg/5ml	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN06870P	ELIXIR	10 mg/5 ml	3/4/1992
CODEINE TABLETS 30 mg	BEACONS PHARMACEUTICALS PTE. LTD.	SIN07044P	TABLET	30 mg	6/3/1992
PROMELIX SYRUP	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN06423P	SYRUP	9 mg/5 ml	7/8/1991
PROCODIN SYRUP	ICM PHARMA PTE. LTD.	SIN04075P	SYRUP	9 mg/5 ml	3/28/1990
UNISEDYL FORTE LINCTUS	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN02919P	ELIXIR	10 mg/5 ml	5/22/1989
BEACTAFED CO SYRUP	BEACONS PHARMACEUTICALS PTE LTD	SIN03140P	SYRUP	10 mg/5 ml	5/30/1989
COLINCTUS 10 MIXTURE 10 mg/5 ml	ICM PHARMA PTE. LTD.	SIN03413P	ELIXIR	10 mg/5 ml	6/22/1989
COPHADYL COUGH LINCTUS	ICM PHARMA PTE. LTD.	SIN09071P	ELIXIR	9 mg/5 ml	12/14/1996
L.T.R. COUGH LINCTUS 10 mg/5 ml	BEACONS PHARMACEUTICALS PTE LTD	SIN03699P	ELIXIR	10 mg/5 ml	8/5/1989
FEDAC COMPOUND LINCTUS	ICM PHARMA PTE. LTD.	SIN03195P	ELIXIR	10 mg/5 ml	6/1/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Codeine Phosphate Injection	东北制药集团沈阳第一制药有限公司	国药准字H21021146	化学药品	注射剂	7/13/2020
Codeine Phosphate Injection	东北制药集团沈阳第一制药有限公司	国药准字H21021147	化学药品	注射剂	7/13/2020
Codeine Phosphate Injection	宜昌人福药业有限责任公司	国药准字H42022494	化学药品	注射剂	6/14/2022
Codeine Phosphate Injection	宜昌人福药业有限责任公司	国药准字H42021991	化学药品	注射剂	6/14/2022
Codeine Phosphate Sustained-release Tablets	西南药业股份有限公司	国药准字H10980001	化学药品	片剂(缓释)	8/24/2020
Codeine Phosphate Tablets	国药集团工业有限公司	国药准字H11020673	化学药品	片剂	6/28/2020
Codeine Phosphate Tablets	青海制药有限公司	国药准字H63020056	化学药品	片剂	5/8/2020
Codeine Phosphate Tablets	南京白敬宇制药厂	国药准字H32022568	化学药品	片剂	7/14/2020
Codeine Phosphate Tablets	青海制药有限公司	国药准字H63020055	化学药品	片剂	5/8/2020
Codeine Phosphate Tablets	国药集团工业有限公司	国药准字H11020672	化学药品	片剂	6/28/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
PROSEDYL COUGH SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	8/20/1985
MOTRACK COUGH SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	9/14/2010
MERSIDYL SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/25/1986
NICE PHENDYL-B LINCTUS	N/A	neochem pharmaceutical laboratories ltd.	N/A	N/A	7/15/1982
NEODINE TAB	N/A	unicorn laboratories o/b american unicorn laboratories limited	N/A	N/A	1/11/2002
COCLEAN SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	6/15/2001
PECOLIN SYRUP	N/A	medipharma ltd	N/A	N/A	3/9/1992
OROSEDYL COUGH SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	2/8/2019
SUPHENIN SYRUP	N/A	medipharma ltd	N/A	N/A	3/28/2001
PACTOREX SYRUP	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	4/20/1979

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

AI-Powered Research

Premium Access