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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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02-Jan-2021
29-Apr-2025
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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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ABOUT THIS PAGE

Looking for 99614-01-4 / Ondansetron Hydrochloride API manufacturers, exporters & distributors?

Ondansetron Hydrochloride manufacturers, exporters & distributors 1

32

PharmaCompass offers a list of Ondansetron Hydrochloride 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 Ondansetron Hydrochloride manufacturer or Ondansetron Hydrochloride supplier for your needs.

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

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

API | Excipient name

Ondansetron Hydrochloride

Synonyms

Ondansetron hcl, 99614-01-4, Zofran, Ondemet, Emeset, Ondansetron (hydrochloride)

Cas Number

99614-01-4

Unique Ingredient Identifier (UNII)

2999F27MAD

About 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.

Emetron Manufacturers

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

Emetron Suppliers

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

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

Emetron USDMF

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

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

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

Emetron JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Emetron Drug Master File in Japan (Emetron JDMF) empowers Emetron API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Emetron JDMF during the approval evaluation for pharmaceutical products. At the time of Emetron JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Emetron suppliers with JDMF on PharmaCompass.

Emetron KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Emetron Drug Master File in Korea (Emetron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Emetron. The MFDS reviews the Emetron KDMF as part of the drug registration process and uses the information provided in the Emetron KDMF to evaluate the safety and efficacy of the drug.

After submitting a Emetron KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Emetron API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Emetron suppliers with KDMF on PharmaCompass.

Emetron CEP

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

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

Emetron WC

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

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

Emetron 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 Emetron as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Emetron GMP

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

Emetron CoA

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

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

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