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Synopsis

Chemistry

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Also known as: 124-90-3, Oxycodone hcl, Oxecta, Oxycontin, Endocodone, Roxicodone
Molecular Formula
C18H22ClNO4
Molecular Weight
351.8  g/mol
InChI Key
MUZQPDBAOYKNLO-RKXJKUSZSA-N
FDA UNII
C1ENJ2TE6C

Oxycodone Hydrochloride
A semisynthetic derivative of CODEINE.
1 2D Structure

Oxycodone Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,4aS,7aR,12bS)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride
2.1.2 InChI
InChI=1S/C18H21NO4.ClH/c1-19-8-7-17-14-10-3-4-12(22-2)15(14)23-16(17)11(20)5-6-18(17,21)13(19)9-10;/h3-4,13,16,21H,5-9H2,1-2H3;1H/t13-,16+,17+,18-;/m1./s1
2.1.3 InChI Key
MUZQPDBAOYKNLO-RKXJKUSZSA-N
2.1.4 Canonical SMILES
CN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)OC)O4)O.Cl
2.1.5 Isomeric SMILES
CN1CC[C@]23[C@@H]4C(=O)CC[C@]2([C@H]1CC5=C3C(=C(C=C5)OC)O4)O.Cl
2.2 Other Identifiers
2.2.1 UNII
C1ENJ2TE6C
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dihydrohydroxycodeinone

2. Dihydrone

3. Dinarkon

4. Eucodal

5. Oxiconum

6. Oxycodeinon

7. Oxycodone

8. Oxycone

9. Oxycontin

10. Pancodine

11. Theocodin

2.3.2 Depositor-Supplied Synonyms

1. 124-90-3

2. Oxycodone Hcl

3. Oxecta

4. Oxycontin

5. Endocodone

6. Roxicodone

7. Oxycodone Hydrochloride Cii

8. Chebi:7859

9. 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one Hydrochloride

10. (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

11. (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydron;chloride

12. Roxicodone (tn)

13. Oxycontin (tn)

14. (4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride

15. Oxecta (tn)

16. Roxybond

17. Oxycodone Monohydrochloride

18. Schembl30095

19. Oxycodone Hydrochloride (usp)

20. Chembl1200890

21. Dtxsid80924674

22. Oxycodone Hydrochloride [mi]

23. Oxycodone Hydrochloride [usan]

24. Akos024457896

25. Oxycodone Hydrochloride [mart.]

26. Oxycodone Hydrochloride [vandf]

27. Anhydrous Oxycodone Hydrochloride

28. Oxycodone Hydrochloride [who-dd]

29. Oxycodone Hydrochloride, Analytical Standard

30. Oxycodone Hydrochloride [orange Book]

31. Oxycodone Hydrochloride Cii [usp-rs]

32. Oxycodone Hydrochloride [ep Monograph]

33. Tylox Component Oxycodone Hydrochloride

34. C08026

35. Codoxy Component Oxycodone Hydrochloride

36. D00847

37. Oxycet Component Oxycodone Hydrochloride

38. Oxycodone Hydrochloride [usp Monograph]

39. Roxicet Component Oxycodone Hydrochloride

40. Roxilox Component Oxycodone Hydrochloride

41. Troxyca Component Oxycodone Hydrochloride

42. Combunox Component Oxycodone Hydrochloride

43. Oxycodone Hydrochloride Component Of Tylox

44. Percocet Component Oxycodone Hydrochloride

45. Percodan Component Oxycodone Hydrochloride

46. Roxiprin Component Oxycodone Hydrochloride

47. Targiniq Component Oxycodone Hydrochloride

48. Xartemis Component Oxycodone Hydrochloride

49. Oxycodone Hydrochloride Component Of Codoxy

50. Oxycodone Hydrochloride Component Of Oxycet

51. Oxycodone Hydrochloride Component Of Roxicet

52. Oxycodone Hydrochloride Component Of Roxilox

53. Oxycodone Hydrochloride Component Of Troxyca

54. Oxycodone Hydrochloride Component Of Combunox

55. Oxycodone Hydrochloride Component Of Percocet

56. Oxycodone Hydrochloride Component Of Percodan

57. Oxycodone Hydrochloride Component Of Roxiprin

58. Oxycodone Hydrochloride Component Of Targiniq

59. Oxycodone Hydrochloride Component Of Xartemis

60. Percodan-demi Component Oxycodone Hydrochloride

61. Q27107601

62. Oxycodone Hydrochloride Component Of Percodan-demi

63. 14-hydroxy-3-methoxy-17-methyl-4,5alpha-epoxymorphinan-6-one Hydrochloride

64. Oxycodone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

65. Oxycodone Hydrochloride, United States Pharmacopeia (usp) Reference Standard

66. (5?)-4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one Hydrochloride

67. (5alpha,17s)-14-hydroxy-3-methoxy-17-methyl-6-oxo-4,5-epoxymorphinan-17-ium Chloride

68. 4,5.alpha.-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one Hydrochloride

69. Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, Hydrochloride, (5.alpha.)-

70. Oxycodone Hydrochloride Solution, 1.0 Mg/ml In Methanol, Analytical Standard, For Drug Analysis

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 351.8 g/mol
Molecular Formula C18H22ClNO4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count5
Rotatable Bond Count1
Exact Mass351.1237359 g/mol
Monoisotopic Mass351.1237359 g/mol
Topological Polar Surface Area59 Ų
Heavy Atom Count24
Formal Charge0
Complexity553
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameOxecta
Drug LabelOXECTA (oxycodone HCl, USP) tablets are an immediate-release opioid analgesic intended for oral administration only. OXECTA contains oxycodone HCl, USP as the active analgesic ingredient. The tablets are round, convex, white and debossed with the str...
Active IngredientOxycodone hydrochloride
Dosage FormTablet
RouteOral
Strength7.5mg; 5mg
Market StatusPrescription
CompanyAcura Pharms

2 of 4  
Drug NameOxycodone hydrochloride
Drug LabelDESCRIPTIONOxyContin (oxycodone hydrochloride controlled-release) Tablets are an opioid analgesic supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg tablet strengths for oral administration...
Active IngredientOxycodone hydrochloride
Dosage FormTablet, extended release; Tablet; Capsule; Solution
Routeoral; Oral
Strength30mg; 100mg/5ml; 15mg; 5mg; 10mg; 5mg/5ml; 80mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyCorepharma; Vintage Pharms; Amneal Pharms; Impax Pharms; Aurolife Pharma; Avanthi; Teva; Endo Pharms; Sun Pharm Inds; Coastal Pharms; Rhodes Pharms; Mallinckrodt; Roxane; Lannett Holdings; Nesher Pharms; Vistapharm; Actavis Elizabeth; Lehigh Valley; Alvog

3 of 4  
Drug NameOxecta
Drug LabelOXECTA (oxycodone HCl, USP) tablets are an immediate-release opioid analgesic intended for oral administration only. OXECTA contains oxycodone HCl, USP as the active analgesic ingredient. The tablets are round, convex, white and debossed with the str...
Active IngredientOxycodone hydrochloride
Dosage FormTablet
RouteOral
Strength7.5mg; 5mg
Market StatusPrescription
CompanyAcura Pharms

4 of 4  
Drug NameOxycodone hydrochloride
Drug LabelDESCRIPTIONOxyContin (oxycodone hydrochloride controlled-release) Tablets are an opioid analgesic supplied in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg tablet strengths for oral administration...
Active IngredientOxycodone hydrochloride
Dosage FormTablet, extended release; Tablet; Capsule; Solution
Routeoral; Oral
Strength30mg; 100mg/5ml; 15mg; 5mg; 10mg; 5mg/5ml; 80mg; 40mg; 20mg
Market StatusTentative Approval; Prescription
CompanyCorepharma; Vintage Pharms; Amneal Pharms; Impax Pharms; Aurolife Pharma; Avanthi; Teva; Endo Pharms; Sun Pharm Inds; Coastal Pharms; Rhodes Pharms; Mallinckrodt; Roxane; Lannett Holdings; Nesher Pharms; Vistapharm; Actavis Elizabeth; Lehigh Valley; Alvog

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)


Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

API SUPPLIERS

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01

Temad Co

Iran
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euroPLX 86 Munich
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Virtual BoothTemad- We think of world-class quality.

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Oxycodone Hydrochloride

About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...

Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Middle East. Apart from complying with Iranian GMP regulations, Temad has acquired the national & international standards of API manufacturing such as ISO 9001/14001/17025/45001 and OHSAS 18001. It currently manufactures more than 115 pharmaceutical products, including narcotics and non-narcotics, in accordance with GMP and WHO standards and regulations. Temad exports its products to 45 countries worldwide.
Temad

02

Veranova

U.S.A
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Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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Oxycodone Hydrochloride

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
Veranova

03

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euroPLX 86 Munich
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Virtual BoothParand Darou is a knowledge-based company, focused on the production of Narcotic APIs.

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Oxycodone Hydrochloride

About the Company : Parand Daro Pharmaceutical Company is a knowledge-based company that commenced operations in 2015, focusing on the production of narcotic medicinal substances. Parand Daro holds th...

Parand Daro Pharmaceutical Company is a knowledge-based company that commenced operations in 2015, focusing on the production of narcotic medicinal substances. Parand Daro holds the distinction of being the second private sector company in Iran to obtain a license from the Food and Drug Organization to manufacture narcotic products. Leveraging opioid raw materials, Parand Daro has successfully produced potent medicinal substances, including codeine phosphate, noscapine, thebaine, papaverine and oxycodone. Apart from catering to domestic demand, Parand Daro has also expanded its reach by exporting its products to global markets.
Parand Darou Pharma

04

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euroPLX 86 Munich
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Oxycodone Hydrochloride

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
Faran Shimi Pharmaceutical

05

EUROAPI

France
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Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Oxycodone Hydrochloride

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.
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06

Rusan Pharma

India
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Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Oxycodone Hydrochloride

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.
Rusan Pharma

07

Noramco

U.S.A
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euroPLX 86 Munich
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Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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Oxycodone Hydrochloride

About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...

Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and manufacturing, Noramco offers services like supply-chain integration for high-purity controlled substances, efficient routes to APIs, analytical data, stability studies, regulatory help, formulation-friendly particle size grades, extended technical packages, DEA-compliant security and production capacity from kilos to multi-ton supply. Noramco also offers world-class supply security for controlled substances, from Schedule I to Schedule III.
Noramco

08

euroPLX 86 Munich
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Oxycodone Hydrochloride

About the Company : Danesh Kimia Pharmed Co. was established on 2011 by industrial and university researchers in order to invest on the production of new pharmaceutical molecules and their ready to us...

Danesh Kimia Pharmed Co. was established on 2011 by industrial and university researchers in order to invest on the production of new pharmaceutical molecules and their ready to use pharmaceutical dosage forms. The company is known as the pioneer generic producer for new entities and ready to use pharmaceutical formulations made by research and production units. It has created a production line for anticancer active ingredients in Baran Chemical and Pharmaceutical Co., molecules in low quantity with high value such as Fingolimod, Nitisinone, Bosentan, etc.
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09

ITALTECNO

Italy
euroPLX 86 Munich
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ITALTECNO

Italy
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euroPLX 86 Munich
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Oxycodone Hcl

About the Company : We are an Italian company that import and export goods and services to all around the world. Our target is to obtain the best quality goods and services to satisfy the requirements...

We are an Italian company that import and export goods and services to all around the world. Our target is to obtain the best quality goods and services to satisfy the requirements of the client and to provide them as quickly as possible. Furthermore, we aim to provide a comprehensive “one-stop” solution so that all your requirements can be purchased from ITALTECNO, from medical and machinery supplies and beyond. We would like to be considered as an extension of the client in terms of the great care and attention, we pay to each specific requirement.
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10

euroPLX 86 Munich
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Oxycodone Hydrochloride

About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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API Reference Price

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27-Dec-2022
27-Jun-2024
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DOSAGE - CAPSULE;ORAL - 5MG

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DOSAGE - SOLUTION;ORAL - 100MG/5ML

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 204031

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 13....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG

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USFDA APPLICATION NUMBER - 208090

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 9MG

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USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 80MG

USFDA APPLICATION NUMBER - 22272

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DOSAGE - TABLET;ORAL - 325MG;5MG

USFDA APPLICATION NUMBER - 87003

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