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    Chemistry

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    Also known as: Ondansetron hcl, 99614-01-4, Zofran, Ondemet, Emeset, Ondansetron (hydrochloride)
    Molecular Formula
    C18H20ClN3O
    Molecular Weight
    329.8  g/mol
    InChI Key
    MKBLHFILKIKSQM-UHFFFAOYSA-N
    FDA UNII
    2999F27MAD
    Ondansetron Hydrochloride
    A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
    1 2D Structure

    Ondansetron Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1H-carbazol-4-one;hydrochloride
    2.1.2 InChI
    InChI=1S/C18H19N3O.ClH/c1-12-19-9-10-21(12)11-13-7-8-16-17(18(13)22)14-5-3-4-6-15(14)20(16)2;/h3-6,9-10,13H,7-8,11H2,1-2H3;1H
    2.1.3 InChI Key
    MKBLHFILKIKSQM-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=NC=CN1CC2CCC3=C(C2=O)C4=CC=CC=C4N3C.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    2999F27MAD
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-

    2. Dihydrate, Ondansetron Monohydrochloride

    3. Gr 38032f

    4. Gr-38032f

    5. Gr38032f

    6. Hydrochloride, Ondansetron

    7. Monohydrochloride Dihydrate, Ondansetron

    8. Monohydrochloride, Ondansetron

    9. Odt, Zofran

    10. Ondansetron

    11. Ondansetron Monohydrochloride

    12. Ondansetron Monohydrochloride Dihydrate

    13. Ondansetron, (+,-)-isomer

    14. Ondansetron, (r)-isomer

    15. Ondansetron, (s)-isomer

    16. Sn 307

    17. Sn-307

    18. Sn307

    19. Zofran

    20. Zofran Odt

    2.3.2 Depositor-Supplied Synonyms

    1. Ondansetron Hcl

    2. 99614-01-4

    3. Zofran

    4. Ondemet

    5. Emeset

    6. Ondansetron (hydrochloride)

    7. Zofran Odt

    8. Nsc 665799

    9. Ondansetronhydrochloride

    10. 2999f27mad

    11. Nsc-665799

    12. C18h20cln3o

    13. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-, Monohydrochloride

    14. Emetron

    15. 1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-4h-carbazol-4-one Hydrochloride

    16. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-1,2,3,9-tetrahydro-4h-carbazol-4-one Hydrochloride

    17. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-2,3-dihydro-1h-carbazol-4(9h)-one Hydrochloride

    18. Smr000469179

    19. Gr 38032

    20. Unii-2999f27mad

    21. Sr-01000763250

    22. Zofran Preservative Free

    23. Zofran And Dextrose In Plastic Container

    24. Cpd000469179

    25. Ondansetron Hydrochloride Preservative Free

    26. 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-4h-carbazol-4-one Monohydrochloride

    27. Schembl41455

    28. Mls001304076

    29. Mls001401397

    30. Mls002222312

    31. Regid_for_cid_68647

    32. Gr 38032 Hcl

    33. Ondansetron Hydrochloride, 98%

    34. Chembl1201111

    35. Ondansetron Hydrochloride- Bio-x

    36. Ondansetron Hydrochloride And Dextrose In Plastic Container

    37. Dtxsid701027913

    38. Hms1571c18

    39. Ondansetron Hydrochloride (zofran)

    40. Hy-b0002

    41. Ondansetron Hydrochloride And Sodium Chloride In Plastic Container

    42. Mfcd00764297

    43. Nsc665799

    44. S1390

    45. Ondansetron Hydrochloride [mi]

    46. Akos015889292

    47. Ab07046

    48. Ccg-100852

    49. Ccg-221058

    50. Cs-1715

    51. Gs-3597

    52. H39o049

    53. Nc00102

    54. Ac-12464

    55. Bo164177

    56. Ondansetron Hydrochloride [who-dd]

    57. Ondansetron Hydrochloride Anhydrous

    58. O0407

    59. Sw100810-5

    60. Vu0424014-2

    61. C90628

    62. (+/-)-ondansetron Hydrochloride Anhydrous

    63. A800774

    64. Ondansetron Hydrochloride Anhydrous, (+/-)-

    65. Q-201515

    66. Sr-01000763250-5

    67. Q27254405

    68. 9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1h-carbazol-4-one;hydrochloride

    69. 1,2,3,4-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-9h-carbazol-4-one Hydrochloride

    70. 4h-carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-, Hydrochloride (1:1)

    71. 9-methyl-3-[(2-methyl-1h-imidazol-1-yl)methyl]-2,3,4,9-tetrahydro-1h-carbazol-4-one Hydrochloride

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 329.8 g/mol
    Molecular Formula C18H20ClN3O
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count2
    Exact Mass329.1294900 g/mol
    Monoisotopic Mass329.1294900 g/mol
    Topological Polar Surface Area39.8 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity440
    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 NameOndansetron hydrochloride
    Drug LabelThe active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (1, 2, 3, 9-te...
    Active IngredientOndansetron hydrochloride
    Dosage FormTablet; Injectable; Solution
    Routeoral; Injection; Oral
    Strengtheq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base
    Market StatusTentative Approval; Prescription
    CompanyAmneal Pharms; Wockhardt; Silarx; Bedford; Hospira; Gland Pharma; Sun Pharm Inds (in); Teva; Apotex; Hikma Farmaceutica; Aurobindo Pharma; Natco Pharma; Taro; Sandoz; Par Pharm; Roxane; Glenmark Generics; Emcure Pharms; Fresenius Kabi Usa; Ipca Labs; Hikm

    2 of 6  
    Drug NameOndansetron hydrochloride preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyWockhardt; Hospira; Teva; Hikma Farmaceutica; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Hikma Maple; Claris Lifesciences; Taro Pharms Ireland; Luitpold; Bedford Labs; Agila Speclts; Bd Rx

    3 of 6  
    Drug NameZofran preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyGlaxosmithkline

    4 of 6  
    Drug NameOndansetron hydrochloride
    Drug LabelThe active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (1, 2, 3, 9-te...
    Active IngredientOndansetron hydrochloride
    Dosage FormTablet; Injectable; Solution
    Routeoral; Injection; Oral
    Strengtheq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base
    Market StatusTentative Approval; Prescription
    CompanyAmneal Pharms; Wockhardt; Silarx; Bedford; Hospira; Gland Pharma; Sun Pharm Inds (in); Teva; Apotex; Hikma Farmaceutica; Aurobindo Pharma; Natco Pharma; Taro; Sandoz; Par Pharm; Roxane; Glenmark Generics; Emcure Pharms; Fresenius Kabi Usa; Ipca Labs; Hikm

    5 of 6  
    Drug NameOndansetron hydrochloride preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyWockhardt; Hospira; Teva; Hikma Farmaceutica; Aurobindo Pharma; Sun Pharm Inds; Sandoz; Emcure Pharms; Fresenius Kabi Usa; Hikma Maple; Claris Lifesciences; Taro Pharms Ireland; Luitpold; Bedford Labs; Agila Speclts; Bd Rx

    6 of 6  
    Drug NameZofran preservative free
    Active IngredientOndansetron hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strengtheq 2mg base/ml
    Market StatusPrescription
    CompanyGlaxosmithkline

    4.2 Drug Indication

    Treatment of alcohol use disorder

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Serotonin 5-HT3 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT3 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT3 RECEPTOR AGONISTS. (See all compounds classified as Serotonin 5-HT3 Receptor Antagonists.)

    Antipruritics

    Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

    Antiemetics

    Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Serotonin-3 Receptor Antagonist [EPC]; Serotonin 3 Receptor Antagonists [MoA]

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    05-Jan-2021
    26-Aug-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20007

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    DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20103

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    DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20103

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    DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20103

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    DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML

    USFDA APPLICATION NUMBER - 20605

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