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    Chemistry

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    Also known as: 959-24-0, Sotalol hcl, Betapace, Betapace af, Sotalex, Sotacor
    Molecular Formula
    C12H21ClN2O3S
    Molecular Weight
    308.83  g/mol
    InChI Key
    VIDRYROWYFWGSY-UHFFFAOYSA-N
    FDA UNII
    HEC37C70XX
    Sotalol Hydrochloride
    An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.
    1 2D Structure

    Sotalol Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[4-[1-hydroxy-2-(propan-2-ylamino)ethyl]phenyl]methanesulfonamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C12H20N2O3S.ClH/c1-9(2)13-8-12(15)10-4-6-11(7-5-10)14-18(3,16)17;/h4-7,9,12-15H,8H2,1-3H3;1H
    2.1.3 InChI Key
    VIDRYROWYFWGSY-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)NCC(C1=CC=C(C=C1)NS(=O)(=O)C)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    HEC37C70XX
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Darob

    2. Mj 1999

    3. Mj-1999

    4. Mj1999

    5. Sotalol

    6. Sotalol Monohydrochloride

    2.3.2 Depositor-Supplied Synonyms

    1. 959-24-0

    2. Sotalol Hcl

    3. Betapace

    4. Betapace Af

    5. Sotalex

    6. Sotacor

    7. Sorine

    8. Mj 1999

    9. Sotalol (hydrochloride)

    10. Sotylize

    11. Darob

    12. Mead Johnson 1999

    13. Sotalol.hcl

    14. (+/-)-sotalol Hydrochloride

    15. Sotalol Monohydrochloride

    16. Betapace (tn)

    17. Sotalol (betapace)

    18. Mj-1999

    19. 4'-(1-hydroxy-2-(isopropylamino)ethyl)methanesulfonanilide Monohydrochloride

    20. Isopropylaminohydroxyethylmethanesulfonanilide Hydrochloride

    21. N-[4-[1-hydroxy-2-(propan-2-ylamino)ethyl]phenyl]methanesulfonamide;hydrochloride

    22. Nsc-337251

    23. Nsc-760358

    24. N-isopropyl-beta-(4-methanesulfonamidophenyl)ethanolamine Hydrochloride

    25. Hec37c70xx

    26. Chebi:9207

    27. 4-(2-isopropylamino-1-hydroxyaethyl)methanesulfonailid Hydrochlorid

    28. Dl-mj-1999

    29. N-[4-[1-hydroxy-2-(isopropylamino)ethyl]phenyl]methanesulfonamide Hydrochloride

    30. 959-24-0 (hcl)

    31. Ncgc00094337-02

    32. Berlex

    33. Dsstox_cid_1278

    34. N-(4-(1-hydroxy-2-(isopropylamino)ethyl)phenyl)methanesulfonamide Hydrochloride

    35. Dsstox_rid_76054

    36. Methanesulfonamide, N-(4-(1-hydroxy-2-((1-methylethyl)amino)ethyl)phenyl)-, Monohydrochloride

    37. N-(4-{1-hydroxy-2-[(1-methylethyl)amino]ethyl}phenyl)methanesulfonamide Hydrochloride

    38. N-{4-[1-hydroxy-2-(propan-2-ylamino)ethyl]phenyl}methanesulfonamide Hydrochloride

    39. Dsstox_gsid_21278

    40. Sotalol Hydrochloride 100 Microg/ml In Acetonitrile

    41. N-(2-hydroxy-2-{4-[(methylsulfonyl)amino]phenyl}ethyl)propan-2-aminium Chloride

    42. N-[4-[1-hydroxy-2-(propan-2-ylamino)ethyl]phenyl]methanesulfonamide Hydrochloride

    43. 366-80-3

    44. Methanesulfonamide, N-[4-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]-, Hydrochloride (1:2)

    45. Smr000326828

    46. Sotalol Hydrochloride [usan]

    47. Sr-01000076116

    48. Einecs 213-496-0

    49. Unii-hec37c70xx

    50. 4'-(1-hydroxy-2-isopropylaminoethyl)methanesulphonanilide Hydrochloride

    51. 4'-[1-hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide Monohydrochloride

    52. N-(4-[1-hydroxy-2-(isopropylamino)ethyl]phenyl)methanesulfonamide Hydrochloride

    53. N-[4-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]methanesulfonamide Hydrochloride

    54. Sotalol, Hcl

    55. Sotalol Hydrochloride [usan:usp]

    56. Mfcd00242937

    57. Sorine (tn)

    58. Cpd000326828

    59. Mj 1999 Hydrochloride

    60. (y)-sotalol Hydrochloride

    61. Cas-959-24-0

    62. (?)-sotalol Hydrochloride

    63. 4-(2-isopropylamino-1-hydroxyaethyl)methanesulfonailid Hydrochlorid [german]

    64. Chembl1700

    65. Sotalol Hydrochloride- Bio-x

    66. Mls000758296

    67. Mls000859969

    68. Mls001401380

    69. Mls002222318

    70. Schembl118761

    71. Dtxsid8021278

    72. Sotalol Hydrochloride (jan/usp)

    73. Hms1571a13

    74. Pharmakon1600-01506043

    75. Sotalol Hydrochloride [mi]

    76. Sotalol Hydrochloride [jan]

    77. Bcp02975

    78. Hy-b0437

    79. Tox21_111267

    80. Tox21_200127

    81. Tox21_501055

    82. Nsc337251

    83. Nsc760358

    84. S2509

    85. Sotalol Hydrochloride [vandf]

    86. Sotalol Hydrochloride [mart.]

    87. Akos015888287

    88. Sotalol Hydrochloride [usp-rs]

    89. Sotalol Hydrochloride [who-dd]

    90. Ac-3541

    91. Ccg-100907

    92. Ccg-213603

    93. Lp01055

    94. Nc00157

    95. Nsc 337251

    96. Nsc 760358

    97. Wln: Ws1&mr Dyq1my1&1 &gh

    98. Methanesulfonanilide, 4'-(1-hydroxy-2-(isopropylamino)ethyl)-, Monohydrochloride

    99. Ncgc00094337-01

    100. Ncgc00094337-03

    101. Ncgc00257681-01

    102. Ncgc00261740-01

    103. As-13017

    104. Bs164418

    105. Bcp0726000245

    106. Sotalol Hydrochloride [orange Book]

    107. Sotalol Hydrochloride [ep Monograph]

    108. Eu-0101055

    109. Ft-0603531

    110. Sotalol Hydrochloride [usp Monograph]

    111. Sw197352-4

    112. ( Inverted Question Mark)-sotalol Hydrochloride

    113. D01026

    114. F21235

    115. S 0278

    116. Sotylize Component Sotalol Hydrochloride

    117. (+/-)-sotalol Hydrochloride, Analytical Standard

    118. 959s240

    119. A845501

    120. Sotalol Hydrochloride Component Of Sotylize

    121. Q-201730

    122. Sr-01000076116-2

    123. Sr-01000076116-3

    124. Sr-01000076116-8

    125. (+/-)-sotalol Hydrochloride, >=98% (tlc), Powder

    126. Q27108309

    127. Sotalol Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    128. [(isopropylamino)hydroxyethyl]methanesulfonanilide Hydrochloride

    129. 4'-[1-hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide Hydrochloride

    130. 4'-[2-(isopropylamino)-1-hydroxyethyl]methanesulfonanilide Hydrochloride

    131. 4'-[2-(isopropylamino)-1-hydroxyethyl]methanesulfonanilide Monohydrochloride

    132. 4-[2-(isopropylamine)-1-hydroxyethyl]methanesulfonanilide Hydrochloride

    133. N-isopropyl-.beta.-(4-methanesulfonamidophenyl)ethanolamine Hydrochloride

    134. P-[1-hydroxy-2-(isopropylamino)ethyl]methanesulfonanilide Hydrochloride

    135. Sotalol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    136. N-(4-{1-hydroxy-2-[(propan-2-yl)amino]ethyl}phenyl)methanesulfonamide Hydrochloride

    137. N-[4-[1-oxidanyl-2-(propan-2-ylamino)ethyl]phenyl]methanesulfonamide Hydrochloride

    138. Methanesulfonamide, N-(4-(1-hydroxy-2-((1-methylethyl)amino)ethyl)phenyl)-, Hydrochloride (1:1)

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 308.83 g/mol
    Molecular Formula C12H21ClN2O3S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count6
    Exact Mass308.0961414 g/mol
    Monoisotopic Mass308.0961414 g/mol
    Topological Polar Surface Area86.8 Ų
    Heavy Atom Count19
    Formal Charge0
    Complexity330
    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 6  
    Drug NameBetapace
    PubMed HealthSotalol (By mouth)
    Drug ClassesAntianginal, Antiarrhythmic, Group III, Cardiovascular Agent
    Drug LabelBetapace AF, (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administ...
    Active IngredientSotalol hydrochloride
    Dosage FormTablet
    RouteOral
    Strength160mg; 120mg; 80mg; 240mg
    Market StatusPrescription
    CompanyBayer Hlthcare

    2 of 6  
    Drug NameBetapace af
    PubMed HealthSotalol
    Drug ClassesAntianginal, Antiarrhythmic, Group III, Cardiovascular Agent
    Drug LabelBetapace AF, (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administ...
    Active IngredientSotalol hydrochloride
    Dosage FormTablet
    RouteOral
    Strength160mg; 120mg; 80mg
    Market StatusPrescription
    CompanyBayer Hlthcare

    3 of 6  
    Drug NameSotalol hydrochloride
    Drug LabelSotalol hydrochloride tablets (AF) are an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. The 80 mg, 120 mg and 160 mg strengths are supplied as light-orange,...
    Active IngredientSotalol hydrochloride
    Dosage FormTablet; Solution
    RouteOral; Intravenous
    Strength150mg/10ml (15mg/ml); 160mg; 120mg; 80mg; 240mg
    Market StatusPrescription
    CompanyVintage Pharms; Impax Pharms; Epic Pharma; Teva; Apotex; Sandoz; Academic Pharms; Mylan

    4 of 6  
    Drug NameBetapace
    PubMed HealthSotalol (By mouth)
    Drug ClassesAntianginal, Antiarrhythmic, Group III, Cardiovascular Agent
    Drug LabelBetapace AF, (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administ...
    Active IngredientSotalol hydrochloride
    Dosage FormTablet
    RouteOral
    Strength160mg; 120mg; 80mg; 240mg
    Market StatusPrescription
    CompanyBayer Hlthcare

    5 of 6  
    Drug NameBetapace af
    PubMed HealthSotalol
    Drug ClassesAntianginal, Antiarrhythmic, Group III, Cardiovascular Agent
    Drug LabelBetapace AF, (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administ...
    Active IngredientSotalol hydrochloride
    Dosage FormTablet
    RouteOral
    Strength160mg; 120mg; 80mg
    Market StatusPrescription
    CompanyBayer Hlthcare

    6 of 6  
    Drug NameSotalol hydrochloride
    Drug LabelSotalol hydrochloride tablets (AF) are an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. The 80 mg, 120 mg and 160 mg strengths are supplied as light-orange,...
    Active IngredientSotalol hydrochloride
    Dosage FormTablet; Solution
    RouteOral; Intravenous
    Strength150mg/10ml (15mg/ml); 160mg; 120mg; 80mg; 240mg
    Market StatusPrescription
    CompanyVintage Pharms; Impax Pharms; Epic Pharma; Teva; Apotex; Sandoz; Academic Pharms; Mylan

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Adrenergic beta-Antagonists

    Drugs that bind to but do not activate beta-adrenergic receptors thereby blocking the actions of beta-adrenergic agonists. Adrenergic beta-antagonists are used for treatment of hypertension, cardiac arrhythmias, angina pectoris, glaucoma, migraine headaches, and anxiety. (See all compounds classified as Adrenergic beta-Antagonists.)

    Anti-Arrhythmia Agents

    Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)

    Sympatholytics

    Drugs that inhibit the actions of the sympathetic nervous system by any mechanism. The most common of these are the ADRENERGIC ANTAGONISTS and drugs that deplete norepinephrine or reduce the release of transmitters from adrenergic postganglionic terminals (see ADRENERGIC AGENTS). Drugs that act in the central nervous system to reduce sympathetic activity (e.g., centrally acting alpha-2 adrenergic agonists, see ADRENERGIC ALPHA-AGONISTS) are included here. (See all compounds classified as Sympatholytics.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Antiarrhythmic [EPC]; Cardiac Rhythm Alteration [PE]; Adrenergic beta-Antagonists [MoA]

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     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    08

    Arevipharma

    Germany

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

    Antibody Engineering
    Not Confirmed
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    Arevipharma

    Germany

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

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    Antibody Engineering
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23752

    Submission : 2010-04-19

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2005-154 - Rev 04

    Issue Date : 2024-02-20

    Type : Chemical

    Substance Number : 2004

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 10920-572

    Start Marketing Date : 2010-11-23

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    09

    Erregierre SpA

    Italy

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

    Antibody Engineering
    Not Confirmed
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    Erregierre SpA

    Italy

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

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    Antibody Engineering
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 13083

    Submission : 1998-07-21

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Country

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

    Antibody Engineering
    Not Confirmed
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    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    Antibody Engineering
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 3754

    Submission : 1980-03-12

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Only 10 entries up to this point, click to access all click full view read-more
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    API Reference Price

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CESAR MARTINELL I BRUNET, 12A08191 RUBIBARCELONA SPAIN","customerAddress":"206, DEVAVRATA,"}]
    27-Jan-2021
    25-Oct-2024
    KGS
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    Average Price (USD/KGS)

    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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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 120MG

    USFDA APPLICATION NUMBER - 19865

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    DOSAGE - TABLET;ORAL - 160MG

    USFDA APPLICATION NUMBER - 19865

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    DOSAGE - TABLET;ORAL - 240MG

    USFDA APPLICATION NUMBER - 19865

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    DOSAGE - TABLET;ORAL - 80MG

    USFDA APPLICATION NUMBER - 19865

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    DOSAGE - TABLET;ORAL - 120MG

    USFDA APPLICATION NUMBER - 21151

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    DOSAGE - TABLET;ORAL - 160MG

    USFDA APPLICATION NUMBER - 21151

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    DOSAGE - TABLET;ORAL - 80MG

    USFDA APPLICATION NUMBER - 21151

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    DOSAGE - SOLUTION;INTRAVENOUS - 150MG/10ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 150MG/10ML (15MG/ML)

    USFDA APPLICATION NUMBER - 22306

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