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    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
    Phenytoin Sodium
    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 Weight 274.25 g/mol
    Molecular Formula C15H11N2NaO2
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count2
    Exact Mass274.07182188 g/mol
    Monoisotopic Mass274.07182188 g/mol
    Topological Polar Surface Area47.2 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity356
    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 NamePhenytoin sodium
    Drug LabelPhenytoin 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 IngredientPhenytoin sodium
    Dosage FormInjectable
    RouteInjection
    Strength50mg/ml
    Market StatusPrescription
    CompanyHospira; Hikma Maple; X-gen Pharms; Luitpold

    2 of 2  
    Drug NamePhenytoin sodium
    Drug LabelPhenytoin 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 IngredientPhenytoin sodium
    Dosage FormInjectable
    RouteInjection
    Strength50mg/ml
    Market StatusPrescription
    CompanyHospira; 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]

    API Reference Price

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    03-Jan-2021
    31-Mar-2025
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    DOSAGE - INJECTABLE;INJECTION - 50MG/ML

    USFDA APPLICATION NUMBER - 84307

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    DOSAGE - CAPSULE;ORAL - 100MG EXTENDED

    USFDA APPLICATION NUMBER - 84349

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    DOSAGE - CAPSULE;ORAL - 30MG EXTENDED

    USFDA APPLICATION NUMBER - 84349

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    ABOUT THIS PAGE

    Looking for 630-93-3 / Phenytoin Sodium API manufacturers, exporters & distributors?

    Phenytoin Sodium manufacturers, exporters & distributors 1

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenytoin Sodium manufacturer or Phenytoin Sodium supplier.

    PharmaCompass also assists you with knowing the Phenytoin Sodium API Price utilized in the formulation of products. Phenytoin Sodium API Price is not always fixed or binding as the Phenytoin Sodium Price is obtained through a variety of data sources. The Phenytoin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Phenytoin Sodium

    Synonyms

    630-93-3, 5,5-diphenylhydantoin sodium salt, Dilantin sodium, Diphenylhydantoin sodium, Diphantoine, Tacosal

    Cas Number

    630-93-3

    Unique Ingredient Identifier (UNII)

    4182431BJH

    About Phenytoin Sodium

    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.

    Fenitron Manufacturers

    A Fenitron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenitron, including repackagers and relabelers. The FDA regulates Fenitron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenitron 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 Fenitron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Fenitron Suppliers

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

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

    Fenitron USDMF

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

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

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

    Fenitron CEP

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

    A Fenitron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fenitron 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 Fenitron suppliers with CEP (COS) on PharmaCompass.

    Fenitron WC

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

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

    Fenitron 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 Fenitron as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Fenitron 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 Fenitron 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 Fenitron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fenitron NDC to their finished compounded human drug products, they may choose to do so.

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

    Fenitron GMP

    Fenitron 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 Fenitron 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 Fenitron GMP manufacturer or Fenitron GMP API supplier for your needs.

    Fenitron CoA

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

    Fenitron CoA mostly includes findings from lab analyses of a specific batch. For each Fenitron 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.

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