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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 12 USDMF, 2 CEP/COS, 4 EU WC, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

23 API Suppliers
12 USDMF
2 CEP/COS
4 EU WC
9 NDC API
13 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers, 38 FDA Orange Book, 2 Europe, 6 Canada, 2 South Africa, 23 Listed Dossiers

71 FDF Dossiers
38 FDA Orange Book
2 Europe
6 Canada
2 South Africa
23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 50MG/ML, CAPSULE;ORAL - 100MG EXTENDED, CAPSULE;ORAL - 30MG EXTENDED

drugProductComposition
INJECTABLE;INJECTION - 50MG/ML
CAPSULE;ORAL - 100MG EXTENDED
CAPSULE;ORAL - 30MG EXTENDED

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 11 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 33 Direct Compression, 25 Controlled & Modified Release, 24 Thickeners and Stabilizers, 21 Granulation, 16 Co-Processed Excipients, 15 Lubricants & Glidants, 15 Taste Masking, 12 Chewable & Orodispersible Aids, 11 Solubilizers, 11 Parenteral, 10 Film Formers & Plasticizers, 9 Topical, 9 Empty Capsules, 8 Disintegrants & Superdisintegrants, 5 Emulsifying Agents, 5 Rheology Modifiers, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices

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3 US Medicaid Prescriptions
8 Finished Drug Prices

MARKET PLACE

10 APIs, 3 FDF Dossiers

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10 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 2 USP , 2 Others

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1 EDQM
2 USP
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 31

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

32,711,638

Annual Reports (USD Million)

Finished Drug Prices

210 RELATED EXCIPIENT COMPANIES

362EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 630-93-3, 5,5-diphenylhydantoin sodium salt, Dilantin sodium, Diphenylhydantoin sodium, Diphantoine, Tacosal

Molecular Formula

C₁₅H₁₁N₂NaO₂

Molecular Weight

274.25 g/mol

InChI Key

FJPYVLNWWICYDW-UHFFFAOYSA-M

FDA UNII

4182431BJH

An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.

1 2D Structure

Phenytoin Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;5,5-diphenylimidazolidin-3-ide-2,4-dione

2.1.2 InChI

InChI=1S/C15H12N2O2.Na/c18-13-15(17-14(19)16-13,11-7-3-1-4-8-11)12-9-5-2-6-10-12;/h1-10H,(H2,16,17,18,19);/q;+1/p-1

2.1.3 InChI Key

FJPYVLNWWICYDW-UHFFFAOYSA-M

2.1.4 Canonical SMILES

C1=CC=C(C=C1)C2(C(=O)[N-]C(=O)N2)C3=CC=CC=C3.[Na+]

2.2 Other Identifiers

2.2.1 UNII

4182431BJH

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 5,5-diphenylhydantoin

2. 5,5-diphenylimidazolidine-2,4-dione

3. Antisacer

4. Difenin

5. Dihydan

6. Dilantin

7. Diphenylhydantoin

8. Diphenylhydantoinate, Sodium

9. Epamin

10. Epanutin

11. Fenitoin

12. Hydantol

13. Phenhydan

14. Phenytoin

15. Sodium Diphenylhydantoinate

2.3.2 Depositor-Supplied Synonyms

1. 630-93-3

2. 5,5-diphenylhydantoin Sodium Salt

3. Dilantin Sodium

4. Diphenylhydantoin Sodium

5. Diphantoine

6. Tacosal

7. Antisacer

8. Phenytoin Sodium Salt

9. Diphentoin

10. Epanutin

11. Solantoin

12. Solantyl

13. Eptoin

14. Sodium Phenytoin

15. Diphenylan Sodium

16. Sodium 2,5-dioxo-4,4-diphenylimidazolidin-1-ide

17. Phenytek

18. Sodium Diphenylhydantoin

19. 5,5-diphenylhydantoin Sodium

20. Mls000554076

21. 2,4-imidazolidinedione, 5,5-diphenyl-, Monosodium Salt

22. 4182431bjh

23. Citrullamon

24. Fenidantoin

25. Novodiphenyl

26. Aladdin

27. Alepsin

28. Cumatil

29. Decatona

30. Dihydan

31. Ditomed

32. Enkefal

33. Epdantoin

34. Epileptin

35. Epsolin

36. Eptolin

37. Fenigramon

38. Fenitron

39. Fenytoin

40. Hidantin

41. Phenilep

42. Smr000146393

43. Ditoin

44. Episar

45. Muldis

46. Fenitoin Sodium

47. Hidantal Sodium

48. Lepitoin Sodium

49. Denyl Sodium

50. Aleviatin Sodium

51. Diphenine Sodium

52. Epilantin-e

53. Fenitoina Sodica

54. Soluble Phenytoin

55. Dilantin Infatabs

56. Metinal Idantoina

57. Di-len

58. Dilantin Injection

59. Dilantin Suspension

60. Om-hydantoine Sodium

61. Sdph

62. Prompt Phenytoin Sodium

63. Sodium;5,5-diphenylimidazolidin-3-ide-2,4-dione

64. Mls000028562

65. Sodium Diphenyl Hydantoinate

66. Diphenylhydantoin Sodium Salt

67. Sodium 5,5-diphenylhydantoinate

68. Phenytoin, Sodium Salt

69. Sodium 5,5-diphenyl Hydantoinate

70. Nsc-757274

71. Extended Phenytoin Sodium

72. Smr000058987

73. Einecs 211-148-2

74. Mfcd00069674

75. Hydantoin, 5,5-diphenyl-, Sodium Salt

76. Phenytoin Sodium [usp:jan]

77. Sodium 5,5-diphenylhydantoin

78. Diphenylhydantoin, Sodium Salt

79. Sodium 5,5-diphenyl-2,4-imidazolidinedione

80. Unii-4182431bjh

81. Hydantoin, 5,5-diphenyl-, Monosodium Salt

82. Opera_id_1233

83. Dsstox_cid_3775

84. Dsstox_rid_77190

85. Dsstox_gsid_23775

86. Spectrum1500485

87. Schembl3051683

88. Dtxsid2023775

89. Phenytoin Sodium [vandf]

90. Hms501j09

91. 5,5-diphenylhydatoin Sodium Salt

92. Phenytoin Sodium [mart.]

93. Phenytoin Sodium [usp-rs]

94. Phenytoin Sodium [who-dd]

95. Phenytoin Sodium [who-ip]

96. Hms1920h10

97. Hms2091p14

98. Hms2233k24

99. Hms3259h11

100. Hms3373o11

101. Phenytoin Sodium Salt [mi]

102. Tox21_302338

103. Ccg-39219

104. Akos003273947

105. Akos015951389

106. Akos025310163

107. Phenytoin Sodium [ep Impurity]

108. Phenytoin Sodium [orange Book]

109. Nc00642

110. Nsc 757274

111. Phenytoin Sodium [ep Monograph]

112. 5,5-diphenylhydantoin Sodium Sigmaultra

113. Phenytoin Sodium [usp Monograph]

114. Ncgc00094758-01

115. Ncgc00094758-02

116. Ncgc00164434-01

117. Ncgc00255285-01

118. As-13308

119. Cas-630-93-3

120. 5,5-diphenylhydantoin Sodium Salt, >=99%

121. Phenytoinum Natricum [who-ip Latin]

122. D1331

123. Diphenylhydantoin Sodium [green Book]

124. Phenytoin Sodium For Injection [jan]

125. En300-49847

126. H12023

127. A834211

128. Sr-05000001698

129. Q-201564

130. Sr-05000001698-1

131. Q27258415

132. 2,4-imidazolidinedione, 5,5-diphenyl-, Sodium Salt (1:1)

133. Phenytoin Sodium, European Pharmacopoeia (ep) Reference Standard

134. Phenytoin Sodium, United States Pharmacopeia (usp) Reference Standard

135. Phenytoin Sodium, Pharmaceutical Secondary Standard; Certified Reference Material

2.3.3 Other Synonyms

1. Phenylhydantoin

2.4 Create Date

2005-06-29

3 Chemical and Physical Properties

Molecular Formula	C₁₅H₁₁N₂NaO₂
Molecular Weight	274.25 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	2
Exact Mass	274.07182188 g/mol
Monoisotopic Mass	274.07182188 g/mol
Topological Polar Surface Area	47.2 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	356
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
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 2
Drug Name	Phenytoin sodium
Drug Label	Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural formula:...
Active Ingredient	Phenytoin sodium
Dosage Form	Injectable
Route	Injection
Strength	50mg/ml
Market Status	Prescription
Company	Hospira; Hikma Maple; X-gen Pharms; Luitpold

2 of 2
Drug Name	Phenytoin sodium
Drug Label	Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2, 4-imidazolidinedione, having the following structural formula:...
Active Ingredient	Phenytoin sodium
Dosage Form	Injectable
Route	Injection
Strength	50mg/ml
Market Status	Prescription
Company	Hospira; Hikma Maple; X-gen Pharms; Luitpold

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anticonvulsants

Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

Cytochrome P-450 CYP1A2 Inducers

Drugs and compounds that induce the synthesis of CYTOCHROME P-450 CYP1A2. (See all compounds classified as Cytochrome P-450 CYP1A2 Inducers.)

Voltage-Gated Sodium Channel Blockers

A class of drugs that inhibit the activation of VOLTAGE-GATED SODIUM CHANNELS. (See all compounds classified as Voltage-Gated Sodium Channel Blockers.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cytochrome P450 1A2 Inducers [MoA]; Cytochrome P450 2B6 Inducers [MoA]; Cytochrome P450 2C19 Inducers [MoA]; Cytochrome P450 2C8 Inducers [MoA]; Cytochrome P450 2C9 Inducers [MoA]; Cytochrome P450 2D6 Inducers [MoA]; Cytochrome P450 3A Inducers [MoA]; Decreased Central Nervous System Disorganized Electrical Activity [PE]; Anti-epileptic Agent [EPC]

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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FDF Dossiers

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FDA Orange Book

01

TARO

U.S.A

American Pharma Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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U.S.A

Virtual Booth

Digital Content

RLD : No

TE Code : AB

PHENYTOIN SODIUM

Brand Name : EXTENDED PHENYTOIN SODIUM

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG EXTENDED

Approval Date : 2006-09-05

Application Number : 40684

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

ACELLA

U.S.A

American Pharma Summit

Not Confirmed

03

WATSON LABS

Ireland

American Pharma Summit

Not Confirmed

04

AM REGENT

U.S.A

American Pharma Summit

Not Confirmed

05

ANI PHARMS

U.S.A

American Pharma Summit

Not Confirmed

06

ANI PHARMS

U.S.A

American Pharma Summit

Not Confirmed

07

HOSPIRA

U.S.A

American Pharma Summit

Not Confirmed

08

SMITH AND NEPHEW

Canada

American Pharma Summit

Not Confirmed

09

SOLOPAK

Australia

American Pharma Summit

Not Confirmed

10

VIATRIS

U.S.A

American Pharma Summit

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 50MG/ML

USFDA APPLICATION NUMBER - 84307

DOSAGE - CAPSULE;ORAL - 100MG EXTENDED

USFDA APPLICATION NUMBER - 84349

DOSAGE - CAPSULE;ORAL - 30MG EXTENDED

USFDA APPLICATION NUMBER - 84349

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US Medicaid Prescriptions

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Market Place

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APIs

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FDF DOSSIERS

Phenytoin Sodium 250 mg Injections needed in Palestine [ENA06858]

Al-Razi Drug Store, a limited private company that is one of the main pharmaceutical products provider to the ministry of health as well as to the Palestinian market is looking for suppliers of Phenytoin Sodium 250 mg Injections. The required quantity is 2000 injections. Interested suppliers can contact them via their email: khalid@al-razi.ps.

16 Mar 2020

Tender// Various Formulations needed in Mauritius [ENA05763]

16 Nov 2019

In-licensing request// Injectable Products Required for the United Kingdom [EN00315][EN00316][EN00317][EN00318][EN00319][EN00320][EN00321]

A global leader in clinical packaging supplies is searching for partners who can provide the following injectable solutions – Phenytoin, 250mg/5ml, 10000 packs/year Haloperidol, 50mg/ml, 1000 packs/year Haloperidol, 100mg/ml, 2000 packs/year Neostigmine, 10mg/10ml (1mg/ml), 22000 packs/year Neostigmine, 5mg/10ml (0.5mg/ml), 22000 packs/year Phenylepherine, 10mg/ml, 6000 packs/year Glycopyrronium Bromide, 0.2mg/ml, 33000 packs/year

03 Mar 2016

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REF. STANDARDS & IMPURITIES

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EDQM

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USP

01

USP

U.S.A

euroPLX 86 Munich

Not Confirmed

02

USP

U.S.A

euroPLX 86 Munich

Not Confirmed

Others

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ABOUT THIS PAGE

Find Phenytoin Sodium manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers

12 USDMF

2 CEP/COS

4 EU WC

9 NDC API

13 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers

38 FDA Orange Book

2 Europe

6 Canada

2 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 50MG/ML

CAPSULE;ORAL - 100MG EXTENDED

CAPSULE;ORAL - 30MG EXTENDED

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

11 DKSH

5 Faran Shimi Pharmaceutical

1 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

3 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

16 BASF

10 Corel Pharma Chem

4 DFE Pharma

2 Finar

7 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

31 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

12 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders

48 Coating Systems & Additives

33 Direct Compression

25 Controlled & Modified Release

24 Thickeners and Stabilizers

21 Granulation

16 Co-Processed Excipients

15 Lubricants & Glidants

15 Taste Masking

12 Chewable & Orodispersible Aids

11 Solubilizers

11 Parenteral

10 Film Formers & Plasticizers

9 Topical

9 Empty Capsules

8 Disintegrants & Superdisintegrants