Overview
Hydrocodone is a synthetic opioid derivative of codeine. It is commonly used in combination with acetaminophen to control moderate to severe pain. Historically, hydrocodone has been used as a cough suppressant although this has largely been replaced by dextromethorphan in current cough and cold formulations. Hydrocodone's more potent metabolite, hydromorphone has also found wide use as an analgesic and is frequently used in cases of severe pain. The FDA first approved Hydrocodone for use as part of the cough suppressant syrup Hycodan in March of 1943.
Background
Hydrocodone is a synthetic opioid derivative of codeine. It is commonly used in combination with acetaminophen to control moderate to severe pain. Historically, hydrocodone has been used as a cough suppressant although this has largely been replaced by dextromethorphan in current cough and cold formulations. Hydrocodone's more potent metabolite, hydromorphone has also found wide use as an analgesic and is frequently used in cases of severe pain. The FDA first approved Hydrocodone for use as part of the cough suppressant syrup Hycodan in March of 1943.
Indication
Hydrocodone is indicated for the management of acute pain, sometimes in combination with acetaminophen or ibuprofen, as well as the symptomatic treatment of the common cold and allergic rhinitis in combination with decongestants, antihistamines, and expectorants.
Associated Conditions
- Acute Pain
- Chronic Pain
- Cough
- Cough caused by Allergic Rhinitis
- Cough caused by Common Cold
- Nasal Congestion caused by Allergic Rhinitis
- Nasal Congestion caused by Common Cold
- Rhinitis caused by Common Cold
- Severe Pain
- Moderate Pain
- Upper respiratory symptoms caused by Allergic Rhinitis
- Upper respiratory symptoms caused by Common Cold
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/05 | Phase 1 | Not yet recruiting | |||
2024/07/03 | Early Phase 1 | Completed | United States Naval Medical Center, San Diego | ||
2024/01/31 | Phase 2 | Active, not recruiting | |||
2022/09/16 | Phase 4 | Completed | |||
2020/01/27 | Phase 4 | Completed | |||
2019/07/05 | Phase 4 | Withdrawn | |||
2019/06/25 | Not Applicable | Completed | |||
2018/08/22 | Phase 1 | Completed | |||
2018/07/06 | Early Phase 1 | Active, not recruiting | |||
2018/06/26 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Tris Pharma Inc | 27808-036 | ORAL | 7.5 mg in 1 1 | 12/19/2023 | |
| Zogenix, Inc. | 43376-320 | ORAL | 20 mg in 1 1 | 2/25/2015 | |
| Physicians Total Care, Inc. | 54868-4034 | ORAL | 10 mg in 1 1 | 5/2/2012 | |
| Tris Pharma Inc | 27808-086 | ORAL | 10 mg in 5 mL | 5/31/2021 | |
| RedPharm Drug, Inc. | 67296-1571 | ORAL | 10 mg in 1 1 | 1/21/2022 | |
| McKesson Packaging Services Business Unit of McKesson Corporation | 63739-455 | ORAL | 5 mg in 1 1 | 6/26/2009 | |
| Aurolife Pharma, LLC | 13107-020 | ORAL | 7.5 mg in 1 1 | 1/11/2022 | |
| STAT Rx USA LLC | 42549-653 | ORAL | 10 mg in 1 1 | 4/13/2012 | |
| American Health Packaging | 68084-895 | ORAL | 5 mg in 1 1 | 7/6/2023 | |
| RedPharm Drug, Inc. | 67296-1425 | ORAL | 10 mg in 1 1 | 2/25/2021 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||