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Tox21_300633

Tox21_300633

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

26 API Suppliers, 10 USDMF, 9 CEP/COS, 1 JDMF, 6 EU WC, 12 NDC API, 13 Listed Suppliers

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API Reference Price, API Exports, FDF Exports

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155 Dossiers, 51 FDA Orange Book, 61 Europe, 14 Canada, 2 South Africa, 27 Listed Dossiers

DRUG PRODUCT COMPOSITION

CONCENTRATE;ORAL - 10MG/ML, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CONCENTRATE;ORAL - 10MG/ML
TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

Suppliers, 25 Kerry, 24 Roquette, 12 Microlex e.U, 10 Sigachi Industries, 9 Actylis, 8 Gangwal Healthcare, 7 Gangwal Chemicals, 6 SPI Pharma, 6 BASF, 5 Nanjing Well Pharmaceutical, 5 DFE Pharma, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 DKSH, 2 Finar, 2 Nanjing Bold Chemical, 2 Ingredion Pharma Solutions, 2 Vasa Pharmachem, 2 Prachin Chemical, 1 Pharmatrans-Sanaq, 1 Ideal Cures Pvt Ltd, 1 Zhejiang Huakang Pharmaceutical, 1 Rochem International Inc, 1 Pfanstiehl, 1 Aeon Procare, 1 Seppic, 1 Shijiazhuang Huaxu Pharmaceutical

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59 Fillers, Diluents & Binders, 26 Direct Compression, 18 Thickeners and Stabilizers, 17 Lubricants & Glidants, 13 Film Formers & Plasticizers, 13 Granulation, 12 Coating Systems & Additives, 12 Parenteral, 12 Co-Processed Excipients, 12 Taste Masking, 10 Disintegrants & Superdisintegrants, 9 Controlled & Modified Release, 8 Chewable & Orodispersible Aids, 7 Topical, 5 Solubilizers, 2 Emulsifying Agents, 1 API Stability Enhancers, 1 Soft Gelatin, 1 Rheology Modifiers

GLOBAL SALES INFORMATION

26 US Medicaid Prescriptions, 20 Finished Drug Prices

MARKET PLACE

7 APIs, 2 DOSSIERS // FDF

PATENTS

4 Health Canada Patents

4 Health Canada Patents

ANALYTICAL SOLUTION(s)

3 EDQM Standards, 1 USP Standards, 2 Other Ref. Standards

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9 News

9 News

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405

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USA (Orange Book)

Europe

Canada

Australia

South Africa

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GLOBAL SALES (USD Million)

U.S. Medicaid

173.00

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145

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USFDA Orange Book Patents

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SERVICES

Also known as: Algolysin, Butalgin, Fenadone, Mecodin, Depridol, Dolophine

Molecular Formula

C₂₁H₂₈ClNO

Molecular Weight

345.9 g/mol

InChI Key

FJQXCDYVZAHXNS-UHFFFAOYSA-N

FDA UNII

229809935B

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

1 2D Structure

Tox21_300633

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

6-(dimethylamino)-4,4-diphenylheptan-3-one;hydrochloride

2.1.2 InChI

InChI=1S/C21H27NO.ClH/c1-5-20(23)21(16-17(2)22(3)4,18-12-8-6-9-13-18)19-14-10-7-11-15-19;/h6-15,17H,5,16H2,1-4H3;1H

2.1.3 InChI Key

FJQXCDYVZAHXNS-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCC(=O)C(CC(C)N(C)C)(C1=CC=CC=C1)C2=CC=CC=C2.Cl

2.2 Other Identifiers

2.2.1 UNII

229809935B

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Amidone

2. Biodone

3. Dolophine

4. Hydrochloride, Methadone

5. Metadol

6. Metasedin

7. Methaddict

8. Methadone

9. Methadose

10. Methex

11. Phenadone

12. Phymet

13. Physeptone

14. Pinadone

15. Symoron

2.3.2 Depositor-Supplied Synonyms

1. Algolysin

2. Butalgin

3. Fenadone

4. Mecodin

5. Depridol

6. Dolophine

7. Methadose

8. Moheptan

9. Miadone

10. Phenadone Hydrochloride

11. Dolofin Hydrochloride

12. 1095-90-5

13. Methadone Hcl

14. Ketalgin Hydrochloride

15. Algidon

16. Fenadon

17. Heptadon

18. Polamidon

19. Adolan

20. Adanon Hydrochloride

21. Physeptone

22. Diaminon Hydrochloride

23. Dl-methadone Hydrochloride

24. Dolophine Hydrochloride

25. Dolohepton

26. Westadone

27. Althose Hydrochloride

28. Mephenon

29. Racemic Methadone Hydrochloride

30. (+-)-methadone Hydrochloride

31. Ccris 3320

32. An-148

33. Methadonium Chloride

34. Dolophin Hydrochloride

35. 4,4-diphenyl-6-dimethylamino-3-heptanone Hydrochloride

36. Hoechst 10820

37. 6-(dimethylamino)-4,4-diphenyl-3-heptanone Hydrochloride

38. Dl-6-dimethylamino-4,4-diphenyl-3-heptanone Hydrochloride

39. An 148

40. Nsc-19600

41. Methadone Hydrochloride Cii

42. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride

43. 6-(dimethylamino)-4,4-diphenylheptan-3-one Hydrochloride

44. 125-56-4

45. Chebi:50140

46. 6-dimethylamino-4,4-diphenyl-3-heptanone.hcl

47. Althose

48. 6-(dimethylamino)-4,4-diphenylheptan-3-one;hydrochloride

49. Tussal

50. Dsstox_cid_501

51. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride, (+-)-

52. Diskets Dispersible

53. Dsstox_rid_75626

54. Dsstox_gsid_20501

55. 229809935b

56. (+-)-tussal

57. (+/-)-methadone Hydrochloride

58. Cas-1095-90-5

59. Einecs 214-140-7

60. Nsc 19600

61. Methadose Oral Concentrate

62. Methadose Sugar-free Oral

63. Biscuits

64. Dollies

65. Macodin

66. Medicine

67. Dolly

68. Methadone Hydrochloride [usp]

69. Methadone Hydrochloride Intensol

70. Tussol:

71. Drg-0023

72. Amidone Hydrochloride

73. Unii-229809935b

74. Azt + Methadone Hcl

75. (+/-)-tussal

76. (.+-.) Tussal

77. Methadone Hydrochloride Dl-

78. Dl-methadone, Hydrochloride

79. Schembl24293

80. Dolophine Hydrochloride (tn)

81. Mls003922099

82. 6-dimethylamino-4,4-diphenyl-3-heptanone Hydrochloride

83. Chembl1200825

84. Dtxsid2020501

85. (.+-.)-methadone Hydrochloride

86. Methadone Hydrochloride (jan/usp)

87. 1,1-diphenyl-1-(2-dimethylaminopropyl)-2-butanone Hydrochloride

88. Nsc19600

89. Methadone Hydrochloride [mi]

90. Tox21_112895

91. Tox21_202026

92. Tox21_300633

93. Methadone Hydrochloride [jan]

94. Methadone Hydrochloride [vandf]

95. Methadone Hydrochloride [usp-rs]

96. Methadone Hydrochloride [who-dd]

97. Ncgc00254397-01

98. Ncgc00259575-01

99. Smr000058978

100. Ft-0671040

101. Methadone Hydrochloride [ep Impurity]

102. Methadone Hydrochloride [orange Book]

103. Methadone Hydrochloride Cii [usp-rs]

104. Methadone Hydrochloride [ep Monograph]

105. D02102

106. Methadone Hydrochloride [usp Monograph]

107. Wln: 2vxr & R & Y2 & N1 & 1

108. 3-heptanone,4-diphenyl-, Hydrochloride,(.+-.)-

109. 3-heptanone,4-diphenyl-, Hydrochloride, (.+-.)-

110. Q26840915

111. (+/-)-methadone Hydrochloride, Powder, >=98% (tlc)

112. 3-heptanone, Dl-6-dimethylamino-4,4-diphenyl-, Hydrochloride

113. 4,4-diphenyl-6-dimethylamino-3-heptanone Hydrochloride (+/-)-

114. Dl-6-(dimethylamino)-4,4-diphenyl-3-heptanone Hydrochloride

115. 4,4-diphenyl-6-(dimethylamino)-3-heptanone Hydrochloride(.+-.)-

116. 6-(dimethylamino)-4,4-diphenyl-3-heptanone Hydrochloride (1:1)

117. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride (1:1)

118. 3-heptanone, 6-(dimethylamino)-4,4-diphenyl-, Hydrochloride (8ci,9ci)

119. (+/-)-methadone Hydrochloride Solution, Drug Standard, 1.0 Mg/ml In Methanol

2.4 Create Date

2005-06-01

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₈ClNO
Molecular Weight	345.9 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	2
Rotatable Bond Count	7
Exact Mass	345.1859422 g/mol
Monoisotopic Mass	345.1859422 g/mol
Topological Polar Surface Area	20.3 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	346
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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 8
Drug Name	Dolophine hydrochloride
Drug Label	DOLOPHINE HYDROCHLORIDE (Methadone Hydrochloride Tablets, USP), for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride i...
Active Ingredient	Methadone hydrochloride
Dosage Form	Injectable; Tablet
Route	Injection; Oral
Strength	5mg; 10mg; 10mg/ml
Market Status	Prescription
Company	Mylan Institutional; Roxane

2 of 8
Drug Name	Methadone hydrochloride
Drug Label	DESCRIPTIONMethadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble.Methadone hydrochloride is chemically describ...
Active Ingredient	Methadone hydrochloride
Dosage Form	Tablet, for suspension; Tablet; Concentrate; Powder; Solution
Route	Oral; For rx compounding
Strength	10mg/5ml; 50gm/bot; 500gm/bot; 10mg/ml; 5mg; 10mg; 100gm/bot; 5mg/5ml; 40mg
Market Status	Prescription
Company	The Pharmanetwork; Mallinckrodt; Sandoz; Roxane; Vistapharm

3 of 8
Drug Name	Methadone hydrochloride intensol
Active Ingredient	Methadone hydrochloride
Dosage Form	Concentrate
Route	Oral
Strength	10mg/ml
Market Status	Prescription
Company	Roxane

4 of 8
Drug Name	Methadose
Drug Label	Methadose Oral Concentrate (methadone hydrochloride oral concentrate USP) is supplied as a cherry flavored liquid concentrate. Methadose Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) is a dye-free, sugar-free, unfla...
Active Ingredient	Methadone hydrochloride
Dosage Form	Tablet, for suspension; Tablet; Concentrate
Route	Oral
Strength	10mg/ml; 5mg; 10mg; 40mg
Market Status	Prescription
Company	Mallinckrodt

5 of 8
Drug Name	Dolophine hydrochloride
Drug Label	DOLOPHINE HYDROCHLORIDE (Methadone Hydrochloride Tablets, USP), for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride i...
Active Ingredient	Methadone hydrochloride
Dosage Form	Injectable; Tablet
Route	Injection; Oral
Strength	5mg; 10mg; 10mg/ml
Market Status	Prescription
Company	Mylan Institutional; Roxane

6 of 8
Drug Name	Methadone hydrochloride
Drug Label	DESCRIPTIONMethadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.Methadone hydrochloride is a white, crystalline material that is water-soluble.Methadone hydrochloride is chemically describ...
Active Ingredient	Methadone hydrochloride
Dosage Form	Tablet, for suspension; Tablet; Concentrate; Powder; Solution
Route	Oral; For rx compounding
Strength	10mg/5ml; 50gm/bot; 500gm/bot; 10mg/ml; 5mg; 10mg; 100gm/bot; 5mg/5ml; 40mg
Market Status	Prescription
Company	The Pharmanetwork; Mallinckrodt; Sandoz; Roxane; Vistapharm

7 of 8
Drug Name	Methadone hydrochloride intensol
Active Ingredient	Methadone hydrochloride
Dosage Form	Concentrate
Route	Oral
Strength	10mg/ml
Market Status	Prescription
Company	Roxane

8 of 8
Drug Name	Methadose
Drug Label	Methadose Oral Concentrate (methadone hydrochloride oral concentrate USP) is supplied as a cherry flavored liquid concentrate. Methadose Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) is a dye-free, sugar-free, unfla...
Active Ingredient	Methadone hydrochloride
Dosage Form	Tablet, for suspension; Tablet; Concentrate
Route	Oral
Strength	10mg/ml; 5mg; 10mg; 40mg
Market Status	Prescription
Company	Mallinckrodt

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antitussive Agents

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)

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.)

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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Agonist [EPC]; Full Opioid Agonists [MoA]