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Oxycodone Hydrochloride

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

30 API Suppliers, 13 USDMF, 11 CEP/COS, 1 JDMF, 1 EU WC, 7 KDMF, 17 NDC API, 17 Listed Suppliers

PRICE INFORMATION

API Reference Price, API Imports, FDF Imports

INTERMEDIATES

2 Suppliers

2 Suppliers

DOSSIERs // Finished Dosage Formulations

737 Dossiers, 289 FDA Orange Book, 289 Europe, 51 Canada, 47 Australia, 17 South Africa, 44 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE;ORAL - 5MG
SOLUTION;ORAL - 100MG/5ML
SOLUTION;ORAL - 5MG/5ML
SOLUTION;ORAL - 5MG/5ML
TABLET;ORAL - 5MG
TABLET;ORAL - 7.5MG
TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG
CAPSULE, EXTENDED RELEASE;ORAL - 18MG
CAPSULE, EXTENDED RELEASE;ORAL - 27MG
CAPSULE, EXTENDED RELEASE;ORAL - 36MG
CAPSULE, EXTENDED RELEASE;ORAL - 9MG
TABLET, EXTENDED RELEASE;ORAL - 10MG
TABLET, EXTENDED RELEASE;ORAL - 15MG
TABLET, EXTENDED RELEASE;ORAL - 20MG
TABLET, EXTENDED RELEASE;ORAL - 30MG
TABLET, EXTENDED RELEASE;ORAL - 40MG
TABLET, EXTENDED RELEASE;ORAL - 60MG
TABLET, EXTENDED RELEASE;ORAL - 80MG
TABLET;ORAL - 325MG;5MG

RELATED EXCIPIENT COMPANIES

Suppliers, 40 Roquette, 39 Kerry, 38 BASF, 22 Corel Pharma Chem, 22 SPI Pharma, 19 Microlex e.U, 14 Actylis, 14 Seppic, 14 Gangwal Healthcare, 13 Gangwal Chemicals, 12 Sigachi Industries, 12 Ideal Cures Pvt Ltd, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 8 Nanjing Well Pharmaceutical, 7 Rochem International Inc, 7 DKSH, 7 Boai NKY Pharmaceuticals Ltd, 7 DFE Pharma, 6 Lonza Capsugel, 5 Ingredion Pharma Solutions, 5 Vasa Pharmachem, 4 Kima Chemical, 4 ACG Worldwide, 4 Pharmatrans-Sanaq, 4 Evonik, 4 Prachin Chemical, 3 Shijiazhuang Huaxu Pharmaceutical, 3 Pfanstiehl, 3 Ulanqab Kema New Material, 3 The Dow Chemical Company, 2 Qualicaps, 2 Pharm-RX Chemical, 2 Alcedo Pharmachem, 2 Nanjing Bold Chemical, 2 Seqens, 2 Finar, 2 Nomisma Healthcare, 2 Zhejiang Huakang Pharmaceutical, 2 Jai Radhe Sales, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Clariant, 1 Aeon Procare, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Bioplus Life Sciences, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

98 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 57 Controlled & Modified Release, 49 Direct Compression, 44 Disintegrants & Superdisintegrants, 38 Taste Masking, 35 Thickeners and Stabilizers, 35 Granulation, 32 Solubilizers, 27 Film Formers & Plasticizers, 26 Parenteral, 25 Lubricants & Glidants, 22 Chewable & Orodispersible Aids, 20 Topical, 19 Co-Processed Excipients, 9 Empty Capsules, 9 API Stability Enhancers, 6 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

GLOBAL SALES INFORMATION

37 US Medicaid Prescriptions, 213 Finished Drug Prices

MARKET PLACE

7 APIs, 9 DOSSIERS // FDF

PATENTS

209 US Patents, 4 US Exclusivities, 55 Health Canada Patents

ANALYTICAL SOLUTION(s)

2 EDQM Standards, 5 USP Standards, 7 Other Ref. Standards

DIGITAL CONTENT

5 Data Compilations & Company Tracker #PharmaFlow, 289 News

API SUPPLIERS

API Suppliers

US DMFs Filed

CEP/COS Certifications

JDMFs Filed

Other Certificates

Other Suppliers

API REF. PRICE (USD / KG)

1,369

API Market Place

INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

289

Europe

289

Canada

Australia

South Africa

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

7,991.00

Annual Reports

189.00

FDF Market Place

EXCIPIENTS

385

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

209

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

289

REF STANDARD

EDQM

USP

Other Listed Suppliers

SERVICES

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

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 Formula	C₁₈H₂₂ClNO₄
Molecular Weight	351.8 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	1
Exact Mass	351.1237359 g/mol
Monoisotopic Mass	351.1237359 g/mol
Topological Polar Surface Area	59 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	553
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Oxecta
Drug Label	OXECTA (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 Ingredient	Oxycodone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	7.5mg; 5mg
Market Status	Prescription
Company	Acura Pharms

2 of 4
Drug Name	Oxycodone hydrochloride
Drug Label	DESCRIPTIONOxyContin (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 Ingredient	Oxycodone hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule; Solution
Route	oral; Oral
Strength	30mg; 100mg/5ml; 15mg; 5mg; 10mg; 5mg/5ml; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; 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 Name	Oxecta
Drug Label	OXECTA (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 Ingredient	Oxycodone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	7.5mg; 5mg
Market Status	Prescription
Company	Acura Pharms

4 of 4
Drug Name	Oxycodone hydrochloride
Drug Label	DESCRIPTIONOxyContin (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 Ingredient	Oxycodone hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule; Solution
Route	oral; Oral
Strength	30mg; 100mg/5ml; 15mg; 5mg; 10mg; 5mg/5ml; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; 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]