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Oxycodone

Generic Name
Oxycodone
Brand Names
Endocet, Endodan Reformulated May 2009, Nalocet, Oxaydo, Oxy.IR, Oxycontin, Oxyneo, Percocet, Prolate, Rivacocet, Roxicet, Roxicodone, Roxybond, Targin, Targiniq, Xolox, Xtampza
Drug Type
Small Molecule
Chemical Formula
C18H21NO4
CAS Number
76-42-6
Unique Ingredient Identifier
CD35PMG570

Overview

Oxycodone is a semisynthetic opioid analgesic derived from thebaine in Germany in 1917. It is currently indicated as an immediate release product for moderate to severe pain and as an extended release product for chronic moderate to severe pain requiring continuous opioid analgesics for an extended period. The first oxycodone containing product, Percodan, was approved by the FDA on April 12, 1950.

Indication

Oxycodone is indicated for the treatment of moderate to severe pain. There is also an extended release formulation indicated for chronic moderate to severe pain requiring continuous opioid analgesics for an extended period.

Associated Conditions

  • Severe Acute Pain
  • Severe Pain
  • Severe, Chronic Pain
  • Acute, moderate Pain
  • Chronic, moderate Pain

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
2016/10/18
NCT02936934
Phase 4
UNKNOWN
Hospital Civil de Guadalajara
Celecoxib After Tonsillectomy
2016/10/14
NCT02934191
Phase 2
Completed
Children's Hospital of Philadelphia
Cannabis Versus Oxycodone for Pain Relief
2016/09/08
NCT02892591
Phase 3
Completed
University of Colorado, Denver
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain
2016/07/06
NCT02824276
Phase 1
Active, not recruiting
Brigham and Women's Hospital
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain
2016/04/18
NCT02741076
Phase 4
Terminated
Member Companies of the Opioid PMR Consortium
Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway
2016/04/15
NCT02740114
Phase 3
Terminated
M.D. Anderson Cancer Center
Population Pharmacokinetic-Pharmacodynamic Study of Intravenous Oxycodone in Malaysian Population
2016/04/05
NCT02728648
Phase 4
Completed
University of Malaya
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
2016/03/23
NCT02716857
Phase 3
Completed
Egalet Ltd
An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.
2016/01/21
NCT02660229
Phase 4
Completed
Mundipharma Korea Ltd
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis
2015/12/09
NCT02625181
Not Applicable
Completed
Vanderbilt University

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Oxycodone Hydrochloride
Rhodes Pharmaceuticals L.P.
42858-003
ORAL
15 mg in 1 1
12/31/2023
Oxycodone Hydrochloride
Bryant Ranch Prepack
72162-1336
ORAL
15 mg in 1 1
3/16/2021
OXYCODONE HYDROCHLORIDE
ATLANTIC BIOLOGICALS CORP.
17856-0826
ORAL
100 mg in 5 mL
4/19/2021
OXYCODONE AND ACETAMINOPHEN
Redpharm Drug, Inc
67296-1855
ORAL
5 mg in 1 1
11/28/2023
Oxycodone Hydrochloride
Major Pharmaceuticals
0904-7180
ORAL
15 mg in 1 1
2/8/2022
OXYCODONE AND ACETAMINOPHEN
Redpharm Drug, Inc
67296-1855
ORAL
5 mg in 1 1
3/9/2023
Oxycodone Hydrochloride
Bryant Ranch Prepack
71335-1414
ORAL
30 mg in 1 1
2/10/2022
OXYCODONE HYDROCHLORIDE
Amneal Pharmaceuticals of New York LLC
0115-1556
ORAL
10 mg in 1 1
3/19/2019
OXYCODONE HCL
DIRECT RX
61919-659
ORAL
15 mg in 1 1
1/21/2020
Oxycodone Hydrochloride
Bryant Ranch Prepack
71335-1023
ORAL
20 mg in 1 1
12/22/2021

EMA Drug Approvals

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Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Approval Date
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NMPA Drug Approvals

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Company
Approval Number
Drug Type
Dosage Form
Approval Date
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PPB Drug Approvals

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Company
Licence No.
Strength
Registration Date
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TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
CHEMMART OXYCODONE MR oxycodone hydrochloride 10mg modified release tablets blister pack
214498
Arrotex Pharmaceuticals Pty Ltd
Medicine
A
11/21/2014
OXYCONTIN oxycodone hydrochloride 30mg modified release tablet blister pack
200025
Mundipharma Pty Ltd
Medicine
A
10/22/2013
CHEMMART OXYCODONE MR oxycodone hydrochloride 40mg tablet blister pack
160095
Arrotex Pharmaceuticals Pty Ltd
Medicine
A
11/11/2010
XEDONE oxycodone hydrochloride 20mg capsule bottle
227859
Medis Pharma Pty Ltd
Medicine
A
11/18/2015
OXYCODONE-WGR oxycodone hydrochloride 5mg film coated tablet blister pack
297750
GM Pharma International Pty Ltd
Medicine
A
5/29/2019

Health Canada Drug Approvals

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Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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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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License Number
Dosage Form
Strength
Approval Date
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Saudi SFDA Drug Approvals

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

Malaysia NPRA Drug Approvals

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Registration Number
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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Holder
MA Number
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Active Ingredient
Authorization Date
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