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Also known as: 24169-02-6, Ifenec, 68797-31-9, Pevaryl, Spectazole, Epi-pevaryl
Molecular Formula
C18H16Cl3N3O4
Molecular Weight
444.7  g/mol
InChI Key
DDXORDQKGIZAME-UHFFFAOYSA-N
FDA UNII
H438WYN10E

Econazole Nitrate
An imidazole derivative that is commonly used as a topical antifungal agent.
1 2D Structure

Econazole Nitrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[2-[(4-chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric acid
2.1.2 InChI
InChI=1S/C18H15Cl3N2O.HNO3/c19-14-3-1-13(2-4-14)11-24-18(10-23-8-7-22-12-23)16-6-5-15(20)9-17(16)21;2-1(3)4/h1-9,12,18H,10-11H2;(H,2,3,4)
2.1.3 InChI Key
DDXORDQKGIZAME-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC(=CC=C1COC(CN2C=CN=C2)C3=C(C=C(C=C3)Cl)Cl)Cl.[N+](=O)(O)[O-]
2.2 Other Identifiers
2.2.1 UNII
H438WYN10E
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Econazole

2. Ekonazole

3. Gyno Pervaryl 150

4. Gyno Pevaril

5. Gyno Pevaryl

6. Gyno-pervaryl 150

7. Gyno-pevaril

8. Gyno-pevaryl

9. Gynopevaril

10. Nitrate, Econazole

11. Pevaryl

2.3.2 Depositor-Supplied Synonyms

1. 24169-02-6

2. Ifenec

3. 68797-31-9

4. Pevaryl

5. Spectazole

6. Epi-pevaryl

7. Gyno-pevaryl

8. Econazole (nitrate)

9. Econazole Nitrate Salt

10. (+-)-econazole Nitrate

11. Gyno-pevaryl 150

12. Econazole Mononitrate

13. Palavale

14. Nsc 243115

15. R 14827

16. R 14,827

17. Sq 13050

18. Econazole Nitrate (spectazole)

19. Mls000028626

20. H438wyn10e

21. 1-(2,4-dichloro-beta-((p-chlorobenzyl)oxy)phenethyl)imidazole Nitrate

22. 1-[2-[(4-chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric Acid

23. Nsc-243115

24. Sq13050

25. 24169-02-6 (nitrate)

26. Smr000058732

27. Sq-13050

28. Dsstox_cid_5226

29. R14827

30. 1-{2-[(4-chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl}-1h-imidazole; Nitric Acid

31. Dsstox_rid_77708

32. Dsstox_gsid_25226

33. Econail

34. R-14827

35. 1h-imidazole, 1-(2-((4-chlorophenyl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-, Nitrate

36. Ccris 6031

37. Nsc243115

38. Sr-01000003142

39. Ncgc00018258-03

40. Einecs 246-053-5

41. Mfcd00058160

42. Unii-h438wyn10e

43. Micogin

44. Ecoza

45. 1-(2-(4-chlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole Nitrate

46. 1h-imidazole, 1-[2-[(4-chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-, Nitrate

47. Spectazole (tn)

48. Prestwick_191

49. Gynoryl

50. Ecoza (tn)

51. Econazole Nitrate [usan:usp:ban:jan]

52. Econazole Nitrate,(s)

53. 1-[2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole Nitrate

54. Opera_id_1393

55. Imidazole, 1-(2,4-dichloro-beta-((p-chlorobenzyl)oxy)phenethyl)-, Mononitrate

56. Cas-24169-02-6

57. 1-[2-[(4-chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole; Nitric Acid

58. Schembl36213

59. Mls001076561

60. Mls002222182

61. Mls002415728

62. Econazole Nitrate (jan/usp)

63. Spectrum1501185

64. Regid_for_cid_68589

65. Econazole Nitrate [mi]

66. Econazole For System Suitability

67. Econazole Nitrate [jan]

68. Chembl1201049

69. Dtxsid6025226

70. Econazole Nitrate [usan]

71. Hms500f15

72. Econazole Nitrate [vandf]

73. Econazole Nitrate [mart.]

74. Hms1568n10

75. Hms1921p03

76. Hms2092l03

77. Hms2095n10

78. Hms2235c19

79. Hms3656c14

80. Hms3712n10

81. Pharmakon1600-01501185

82. Econazole Nitrate [usp-rs]

83. Econazole Nitrate [who-dd]

84. Bcp12552

85. Hy-b0453

86. Tox21_110852

87. Tox21_200771

88. Tox21_303391

89. Ccg-38966

90. Nsc757882

91. S2535

92. Akos015895218

93. Tox21_110852_1

94. Ab02338

95. Ac-1113

96. Econazole Nitrate [ep Impurity]

97. Econazole Nitrate [orange Book]

98. Nsc 757882

99. Nsc-757882

100. 1-(2-((4-chlorophenyl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazolium Nitrate

101. 1h-imidazole, 1-(2-((4-chlorophenyl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-, Mononitrate

102. Econazole Nitrate [ep Monograph]

103. Econazole Nitrate [usp Monograph]

104. Ncgc00018258-10

105. Ncgc00089813-02

106. Ncgc00094926-01

107. Ncgc00094926-02

108. Ncgc00094926-03

109. Ncgc00094926-04

110. Ncgc00257500-01

111. Ncgc00258325-01

112. As-13263

113. E0957

114. Econazole Nitrate 100 Microg/ml In Methanol

115. Ft-0625644

116. Ft-0630510

117. Sw196500-3

118. Vu0239797-5

119. C08069

120. D00881

121. 1h-imidazole,4-dichlorophenyl]ethyl)-, Nitrate

122. A817124

123. A836253

124. 1h-imidazole,4-dichlorophenyl)ethyl]-, Mononitrate

125. J-015380

126. Sr-01000003142-2

127. Sr-01000003142-3

128. Q27279621

129. 1-[2-(4-chlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]imidazole Nitrate

130. Imidazole,4-dichloro-.beta.-[(p-chlorobenzyl)oxy]phenethyl]-, Mononitrate

131. (+/-)-1-(2,4-dichloro-.beta.-((p-chlorobenzyl)oxy)phenethyl)-imidazole Mononitrate

132. 1-[2-[(4-chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole Nitrate;econazole Nitrate

133. 1h-imidazole, 1-(2-((4-chlorophenyl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-, Mononitrate, (+/-)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 444.7 g/mol
Molecular Formula C18H16Cl3N3O4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count6
Exact Mass443.020639 g/mol
Monoisotopic Mass443.020639 g/mol
Topological Polar Surface Area93.1 Ų
Heavy Atom Count28
Formal Charge0
Complexity404
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameEconazole nitrate
Drug LabelEconazole Nitrate Cream, 1% contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxyl 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-w...
Active IngredientEconazole nitrate
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyFougera Pharms; Igi Labs; Perrigo New York; Taro

2 of 2  
Drug NameEconazole nitrate
Drug LabelEconazole Nitrate Cream, 1% contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxyl 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-w...
Active IngredientEconazole nitrate
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyFougera Pharms; Igi Labs; Perrigo New York; Taro

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

14-alpha Demethylase Inhibitors

Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)


Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Azoles [CS]; Azole Antifungal [EPC]

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10-Feb-2021
21-Nov-2024
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DOSAGE - CREAM;TOPICAL - 1% **Federal Registe...DOSAGE - CREAM;TOPICAL - 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18751

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DOSAGE - AEROSOL, FOAM;TOPICAL - 1%

USFDA APPLICATION NUMBER - 205175

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ABOUT THIS PAGE

Econazole Nitrate Manufacturers

A Econazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Econazole Nitrate, including repackagers and relabelers. The FDA regulates Econazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Econazole Nitrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Econazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Econazole Nitrate Suppliers

A Econazole Nitrate supplier is an individual or a company that provides Econazole Nitrate active pharmaceutical ingredient (API) or Econazole Nitrate finished formulations upon request. The Econazole Nitrate suppliers may include Econazole Nitrate API manufacturers, exporters, distributors and traders.

click here to find a list of Econazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Econazole Nitrate USDMF

A Econazole Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Econazole Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Econazole Nitrate DMFs exist exist since differing nations have different regulations, such as Econazole Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Econazole Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Econazole Nitrate USDMF includes data on Econazole Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Econazole Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Econazole Nitrate suppliers with USDMF on PharmaCompass.

Econazole Nitrate CEP

A Econazole Nitrate CEP of the European Pharmacopoeia monograph is often referred to as a Econazole Nitrate Certificate of Suitability (COS). The purpose of a Econazole Nitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Econazole Nitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Econazole Nitrate to their clients by showing that a Econazole Nitrate CEP has been issued for it. The manufacturer submits a Econazole Nitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Econazole Nitrate CEP holder for the record. Additionally, the data presented in the Econazole Nitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Econazole Nitrate DMF.

A Econazole Nitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Econazole Nitrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Econazole Nitrate suppliers with CEP (COS) on PharmaCompass.

Econazole Nitrate WC

A Econazole Nitrate written confirmation (Econazole Nitrate WC) is an official document issued by a regulatory agency to a Econazole Nitrate manufacturer, verifying that the manufacturing facility of a Econazole Nitrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Econazole Nitrate APIs or Econazole Nitrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Econazole Nitrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Econazole Nitrate suppliers with Written Confirmation (WC) on PharmaCompass.

Econazole Nitrate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Econazole Nitrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Econazole Nitrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Econazole Nitrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Econazole Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Econazole Nitrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Econazole Nitrate suppliers with NDC on PharmaCompass.

Econazole Nitrate GMP

Econazole Nitrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Econazole Nitrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Econazole Nitrate GMP manufacturer or Econazole Nitrate GMP API supplier for your needs.

Econazole Nitrate CoA

A Econazole Nitrate CoA (Certificate of Analysis) is a formal document that attests to Econazole Nitrate's compliance with Econazole Nitrate specifications and serves as a tool for batch-level quality control.

Econazole Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Econazole Nitrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Econazole Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Econazole Nitrate EP), Econazole Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Econazole Nitrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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