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Chemistry

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Also known as: 156-51-4, Phenelzine sulfate salt, Estinerval, Nardelzine, Phenelzine sulphate, Phenelzine (sulfate)
Molecular Formula
C8H14N2O4S
Molecular Weight
234.28  g/mol
InChI Key
RXBKMJIPNDOHFR-UHFFFAOYSA-N
FDA UNII
2681D7P965

Phenelzine Sulfate
One of the MONOAMINE OXIDASE INHIBITORS used to treat DEPRESSION; PHOBIC DISORDERS; and PANIC.
1 2D Structure

Phenelzine Sulfate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-phenylethylhydrazine;sulfuric acid
2.1.2 InChI
InChI=1S/C8H12N2.H2O4S/c9-10-7-6-8-4-2-1-3-5-8;1-5(2,3)4/h1-5,10H,6-7,9H2;(H2,1,2,3,4)
2.1.3 InChI Key
RXBKMJIPNDOHFR-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC=C(C=C1)CCNN.OS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
2681D7P965
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2 Phenethylhydrazine

2. 2-phenethylhydrazine

3. Beta Phenylethylhydrazine

4. Beta-phenylethylhydrazine

5. Fenelzin

6. Nardelzine

7. Nardil

8. Phenelzine

9. Phenethylhydrazine

10. Sulfate, Phenelzine

2.3.2 Depositor-Supplied Synonyms

1. 156-51-4

2. Phenelzine Sulfate Salt

3. Estinerval

4. Nardelzine

5. Phenelzine Sulphate

6. Phenelzine (sulfate)

7. Phenethylhydrazine Sulfate

8. Phenethylhydrazin

9. Mao-rem

10. Phenelzine Bisulfate

11. Phenylethylhydrazine Sulfate

12. Phenelzine Acid Sulfate

13. Phenelzine Hydrogen Sulfate

14. Hydrazine, (2-phenylethyl)-, Sulfate (1:1)

15. Phenalzine Dihydrogen Sulfate

16. Phenelzine Dihydrogen Sulfate

17. Wl 7

18. Phenethylhydrazine Sulfate (1:1)

19. N-1544a

20. 2-phenylethylhydrazine Dihydrogen Sulfate

21. (2-phenylethyl)hydrazine Sulfate

22. 2-phenylethylhydrazine;sulfuric Acid

23. S 1544

24. Phenelzine Sulfate [usp]

25. Hydrazine, (2-phenylethyl)-, Sulfate

26. Nsc-170957

27. 156-51-4 (sulfate)

28. Chebi:8061

29. Alacine

30. Alazin

31. 2681d7p965

32. Dsstox_cid_1144

33. Phenelzine Sulfate (usp)

34. Dsstox_rid_75973

35. Dsstox_gsid_21144

36. Phenelzine Hydrogen Sulphate

37. Phenelzine Bisulphate

38. Phenethylhydrazine Sulphate

39. Phenylethylhydrazine Sulphate

40. Smr000058500

41. Ccris 498

42. 2-phenylethylhydrazine Sulphate

43. Beta-phenylethylhydrazine Sulfate

44. Sr-01000076074

45. Einecs 205-856-0

46. Ep-411

47. Nsc 170957

48. Phenylethylhydrazine Dihydrogen Sulphate

49. 2-phenylethylhydrazine Hydrogen Sulphate

50. Felazine

51. Phelazin

52. Phenelzin

53. Phenline

54. 2-phenylethylhydrazine Dihydrogen Sulphate

55. Beta-phenylethylhydrazine Hydrogen Sulphate

56. Beta-phenylethylhydrazine Dihydrogen Sulfate

57. Phenelzinesulfate

58. 1-hydrazino-2-phenylethane Hydrogen Sulphate

59. P 1531

60. Unii-2681d7p965

61. Prestwick_595

62. Mfcd00050687

63. Nardil (tn)

64. Phenylaethyl-hydrazin

65. W 1544a

66. Hydrazine, Phenethyl-, Sulfate (1:1)

67. Phenelzine-[d4] Sulfate

68. Phenethyl Hydrazine Sulfate

69. Schembl40652

70. 2-phenethyl-hydrazine Sulfate

71. 2-phenylethylhydrazine Sulfate

72. Mls000069778

73. Mls000758253

74. Mls001423996

75. Spectrum1500476

76. Chembl1200895

77. Dtxsid3021144

78. 2-phenethylhydrazine Sulfate Salt

79. Hms500d04

80. Hy-b1018a

81. Phenelzine Sulfate [iarc]

82. Hms1568b21

83. Hms1920j08

84. Hms2051i11

85. Hms2091n20

86. Hms2095b21

87. Hms2233n22

88. Hms3263c03

89. Hms3393i11

90. Hms3712b21

91. Pharmakon1600-01500476

92. Phenelzine Sulfate [vandf]

93. .beta.-phenylethylhydrazine Sulfate

94. Phenelzine Sulfate [mart.]

95. Phenelzine Sulfate [usp-rs]

96. Phenelzine Sulfate [who-dd]

97. Tox21_110236

98. Tox21_200134

99. Tox21_500971

100. Ccg-40227

101. Nsc170957

102. Nsc757268

103. Phenelzine Acid Sulfate [mi]

104. (2-phenylethyl)hydrazine Sulfuric Acid

105. Akos015914085

106. Tox21_110236_1

107. Cs-4533

108. Lp00971

109. Nc00037

110. Nsc-757268

111. Phenelzine Sulfate [orange Book]

112. Ncgc00015830-08

113. Ncgc00094271-01

114. Ncgc00094271-02

115. Ncgc00094271-03

116. Ncgc00094271-04

117. Ncgc00094271-05

118. Ncgc00257688-01

119. Ncgc00261656-01

120. Phenelzine Sulfate [usp Monograph]

121. Phenethylhydrazine Sulphate (1:1)

122. Eu-0100971

123. Ft-0673678

124. .beta.-phenylethylhydrazine Dihydrogen Sulfate

125. C07431

126. D00505

127. P 6777

128. J-009308

129. Sr-01000076074-1

130. Sr-01000076074-6

131. Sr-01000076074-8

132. Hydrazine, (2-phenylethyl)-, Sulphate (1:1)

133. Q27107688

134. Phenelzine Sulfate, United States Pharmacopeia (usp) Reference Standard

135. Wln: Zm2r & Wsqqalacinealazineep-411estinervalfenelsinfenetsinfenelzinafenizinkalganmao-remmonofenmonophenmonoten

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 234.28 g/mol
Molecular Formula C8H14N2O4S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count3
Exact Mass234.06742811 g/mol
Monoisotopic Mass234.06742811 g/mol
Topological Polar Surface Area121 Ų
Heavy Atom Count15
Formal Charge0
Complexity159
Isotope Atom Count0
Defined Atom Stereocenter Count0
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 2  
Drug NamePhenelzine sulfate
Drug LabelPhenelzine Sulfate Tablets, USP (phenelzine sulfate) is a potent inhibitor of monoamine oxidase(MAO). Phenelzine sulfate is a hydrazine derivative. It has a molecular weight of 234.27 and is chemically described as C8H12N2 H2SO4. Its chemical stru...
Active IngredientPhenelzine sulfate
Dosage FormTablet
RouteOral
Strengtheq 15mg base
Market StatusPrescription
CompanyNovel Labs

2 of 2  
Drug NamePhenelzine sulfate
Drug LabelPhenelzine Sulfate Tablets, USP (phenelzine sulfate) is a potent inhibitor of monoamine oxidase(MAO). Phenelzine sulfate is a hydrazine derivative. It has a molecular weight of 234.27 and is chemically described as C8H12N2 H2SO4. Its chemical stru...
Active IngredientPhenelzine sulfate
Dosage FormTablet
RouteOral
Strengtheq 15mg base
Market StatusPrescription
CompanyNovel Labs

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antidepressive Agents

Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)


Monoamine Oxidase Inhibitors

A chemically heterogeneous group of drugs that have in common the ability to block oxidative deamination of naturally occurring monoamines. (From Gilman, et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed, p414) (See all compounds classified as Monoamine Oxidase Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Monoamine Oxidase Inhibitors [MoA]; Monoamine Oxidase Inhibitor [EPC]

API SUPPLIERS

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Procos

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Procos

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
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Tyche Industries Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Tyche Industries Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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03

Siegfried AG

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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Siegfried AG

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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04

CML EUROPE BV

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPHI Middle east
Not Confirmed
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CML EUROPE BV

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CPHI Middle east
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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Cml Europe Bv

U.S.A

USDMF

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CPHI Middle east
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01

CPHI Middle east
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18400

Submission : 2005-06-10

Status : Inactive

Type : II

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02

Procos Spa

Italy

USDMF

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CPHI Middle east
Not Confirmed

03

Siegfried Evionnaz Sa

Switzerland

USDMF

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CPHI Middle east
Not Confirmed

03

04

Tyche Industries Ltd

India

USDMF

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CPHI Middle east
Not Confirmed

04

CPHI Middle east
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2017-07-11

Pay. Date : 2017-01-09

DMF Number : 31303

Submission : 2017-01-12

Status : Active

Type : II

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NDC API

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CPHI Middle east
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PHENELZINE SULFATE

NDC Package Code : 46016-1562

Start Marketing Date : 2003-09-01

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

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CPHI Middle east
Not Confirmed
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CPHI Middle east
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PHENELZINE SULFATE

NDC Package Code : 60862-004

Start Marketing Date : 2016-08-30

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Procos

Italy
CPHI Middle east
Not Confirmed
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Procos

Italy
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CPHI Middle east
Not Confirmed

PHENELZINE SULFATE

About the Company : Procos S.p.A. is a wholly owned subsidiary of the Japanese company, CBC Co. Ltd Group, specializing in the development, scale-up and production of Active Pharmaceutical Ingredients...

Procos S.p.A. is a wholly owned subsidiary of the Japanese company, CBC Co. Ltd Group, specializing in the development, scale-up and production of Active Pharmaceutical Ingredients (APIs), advanced intermediates and related services for the pharmaceutical industry. Our core business sectors include custom synthesis and Generic API manufacturing. The manufacturing site is located in Cameri, Italy. This 110,000 sq. meter, cutting-edge multipurpose plant, fully designed under cGMP compliance, has been successfully audited and approved by the main regulatory authorities including AIFA, FDA and PMDA.
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02

Siegfried AG

Switzerland
CPHI Middle east
Not Confirmed
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Siegfried AG

Switzerland
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CPHI Middle east
Not Confirmed

Phenelzine Sulfate

About the Company : As an internationally renowned outsourcing partner, we offer products and tailor-made service packages that are seamlessly embedded in the value chain of our customers. Our pharmac...

As an internationally renowned outsourcing partner, we offer products and tailor-made service packages that are seamlessly embedded in the value chain of our customers. Our pharmaceutical industry partners benefit from a wide range of offers - from the development of active ingredients to development services for ready-made drugs, their approval and production to packaging and logistics. As a former fully integrated pharmaceutical company, Siegfried is now one of the few suppliers who can develop both active ingredients and ready-made drugs under one roof. This combination of experience and know-how is unique in the CDMO market.
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FDF Dossiers

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01

Link Healthcare

Australia
AES 2024
Not Confirmed
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Link Healthcare

Australia
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AES 2024
Not Confirmed

phenelzine

Brand Name : Nardil

Dosage Form : tablet

Dosage Strength : 15 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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AES 2024
Not Confirmed
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AES 2024
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phenelzine

Brand Name : Nardil (Canada)

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

AES 2024
Not Confirmed
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AES 2024
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PHENELZINE SULFATE

Brand Name : PHENELZINE SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Packaging :

Approval Date : 2010-12-08

Application Number : 200181

Regulatory Info : RX

Registration Country : USA

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04

Pfizer Inc

U.S.A
AES 2024
Not Confirmed
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Pfizer Inc

U.S.A
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AES 2024
Not Confirmed

PHENELZINE SULFATE

Brand Name : NARDIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Packaging :

Approval Date : 1982-01-01

Application Number : 11909

Regulatory Info : RX

Registration Country : USA

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05

AES 2024
Not Confirmed
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AES 2024
Not Confirmed

PHENELZINE (PHENELZINE SULFATE)

Brand Name : NARDIL

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging : 100

Approval Date :

Application Number : 476552

Regulatory Info : Prescription

Registration Country : Canada

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FDA Orange Book

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AES 2024
Not Confirmed
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AES 2024
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PHENELZINE SULFATE

Brand Name : PHENELZINE SULFATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2010-12-08

Application Number : 200181

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

PARKE DAVIS

U.S.A
AES 2024
Not Confirmed
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PARKE DAVIS

U.S.A
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AES 2024
Not Confirmed

PHENELZINE SULFATE

Brand Name : NARDIL

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 1982-01-01

Application Number : 11909

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Canada

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CPHI Middle east
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CPHI Middle east
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PHENELZINE (PHENELZINE SULFATE)

Brand Name : NARDIL

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging : 100

Approval Date :

Application Number : 476552

Regulatory Info : Prescription

Registration Country : Canada

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Australia

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Antibody Engineering
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Antibody Engineering
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phenelzine

Brand Name : Nardil

Dosage Form : tablet

Dosage Strength : 15 mg

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Antibody Engineering
Not Confirmed
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Antibody Engineering
Not Confirmed

phenelzine

Brand Name : Nardil (Canada)

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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