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.
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/10/08 | Phase 1 | Completed | |||
2015/09/11 | Phase 4 | Completed | |||
2014/11/20 | Not Applicable | Completed | |||
2013/05/03 | Phase 1 | Completed | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH | ||
2013/02/11 | Phase 1 | Completed | |||
2012/08/31 | Phase 3 | Terminated | |||
2012/08/24 | Phase 4 | Completed | Tan Tock Seng Hospital | ||
2011/07/26 | Phase 3 | Completed | |||
2011/03/24 | Phase 1 | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||
2010/12/28 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eywa Pharma Inc | 71930-056 | ORAL | 60 mg in 1 1 | 5/20/2021 | |
| Rebel Distributors Corp | 21695-336 | ORAL | 10 mg in 5 mL | 8/27/2009 | |
| A-S Medication Solutions | 50090-3011 | ORAL | 60 mg in 1 1 | 12/28/2023 | |
| Advanced Rx of Tennessee, LLC | 80425-0530 | ORAL | 60 mg in 1 1 | 6/2/2025 | |
| Rebel Distributors Corp. | 21695-243 | ORAL | 60 mg in 1 1 | 12/1/2009 | |
| Actavis Pharma, Inc. | 52544-082 | ORAL | 30 mg in 1 1 | 3/1/2021 | |
| Physicians Total Care, Inc. | 54868-0263 | ORAL | 10 mg in 5 mL | 12/9/2011 | |
| PAI Holdings, LLC | 0121-0504 | ORAL | 12 mg in 5 mL | 10/16/2023 | |
| RxChange Co. | 33358-001 | ORAL | 30 mg in 1 1 | 11/5/2014 | |
| NuCare Pharmaceuticals, Inc. | 68071-3061 | ORAL | 30 mg in 1 1 | 2/10/2021 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SUNSEDYL COUGH LINCTUS | SIN03490P | ELIXIR | 9 mg/5 ml | 6/26/1989 | |
| SUNSEDYL FORTE COUGH LINCTUS | SIN07750P | ELIXIR | 10.0 mg/5 ml | 6/21/1994 | |
| UNIDRYL CD EXPECTORANT | SIN02917P | SYRUP | 5mg/5ml | 5/22/1989 | |
| PHENEXPECT CD SYRUP | SIN06702P | SYRUP | 5.7 mg/5 ml | 12/3/1991 | |
| PARACETAMOL CODEINE TABLETS | SIN06330P | TABLET | 8 mg | 7/2/1991 | |
| CHLORSEDYL LINCTUS | SIN02933P | ELIXIR | 9 mg/5 ml | 5/22/1989 | |
| PACOFEN TABLETS | SIN06271P | TABLET | 8 mg | 5/7/1991 | |
| DHASEDYL SYRUP | SIN06928P | SYRUP | 9 mg/5 ml | 4/13/1992 | |
| COPHADYL-E COUGH LINCTUS | SIN09104P | ELIXIR | 9 mg/5 ml | 12/28/1996 | |
| PANACO TABLETS | SIN05462P | TABLET | 9 mg | 2/19/1991 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Codeine Phosphate Syrup | 国药准字H21020263 | 化学药品 | 糖浆剂 | 5/12/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CECOL COUGH SYRUP | N/A | N/A | N/A | 2/15/2019 | |
| MARSEDYL ELIXIR | N/A | N/A | N/A | 2/25/1984 | |
| PFC COUGH SYRUP CM FORMULA | N/A | N/A | N/A | 7/9/2010 | |
| COFFTIER COUGH SYRUP | N/A | N/A | N/A | 2/15/2008 | |
| COCURE COUGH SYRUP | N/A | N/A | N/A | 7/13/2001 | |
| UNI-CODPLEX SYRUP | N/A | N/A | N/A | 12/14/1998 | |
| DECOL COUGH SYRUP | N/A | N/A | N/A | 2/15/2019 | |
| ROYAL COUGH SYRUP | N/A | N/A | N/A | 7/8/2019 | |
| DIPHETAN COUGH SYRUP | N/A | N/A | N/A | 8/20/1986 | |
| THENADYL E C COMPOUND SYRUP | N/A | N/A | N/A | 5/3/1979 |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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