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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
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
| Molecular Weight | 329.8 g/mol |
|---|---|
| Molecular Formula | C18H20ClN3O |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 2 |
| Exact Mass | 329.1294900 g/mol |
| Monoisotopic Mass | 329.1294900 g/mol |
| Topological Polar Surface Area | 39.8 Ų |
| Heavy Atom Count | 23 |
| Formal Charge | 0 |
| Complexity | 440 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 6 | |
|---|---|
| Drug Name | Ondansetron hydrochloride |
| Drug Label | The 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 Ingredient | Ondansetron hydrochloride |
| Dosage Form | Tablet; Injectable; Solution |
| Route | oral; Injection; Oral |
| Strength | eq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Amneal 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 Name | Ondansetron hydrochloride preservative free |
| Active Ingredient | Ondansetron hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2mg base/ml |
| Market Status | Prescription |
| Company | Wockhardt; 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 Name | Zofran preservative free |
| Active Ingredient | Ondansetron hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2mg base/ml |
| Market Status | Prescription |
| Company | Glaxosmithkline |
| 4 of 6 | |
|---|---|
| Drug Name | Ondansetron hydrochloride |
| Drug Label | The 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 Ingredient | Ondansetron hydrochloride |
| Dosage Form | Tablet; Injectable; Solution |
| Route | oral; Injection; Oral |
| Strength | eq 4mg base; eq 2mg base/ml; eq 4mg base/5ml; eq 16mg; eq 16mg base; 16mg; eq 24mg base; eq 8mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Amneal 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 Name | Ondansetron hydrochloride preservative free |
| Active Ingredient | Ondansetron hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2mg base/ml |
| Market Status | Prescription |
| Company | Wockhardt; 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 Name | Zofran preservative free |
| Active Ingredient | Ondansetron hydrochloride |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 2mg base/ml |
| Market Status | Prescription |
| Company | Glaxosmithkline |
Treatment of alcohol use disorder
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.)
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Issue Date : 2012-05-24
Type : Chemical
Substance Number : 2016
Status : Valid
NDC Package Code : 64567-0005
Start Marketing Date : 2009-08-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Initial Date of Registration : 2009-06-30
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NDC Package Code : 55111-017
Start Marketing Date : 2010-01-01
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DMF Number : 15990
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Inke S.A: APIs manufacturing plant.
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Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2005-056 - Rev 00
Status : Valid
Issue Date : 2012-05-24
Type : Chemical
Substance Number : 2016
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Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2005-071 - Rev 06
Status : Valid
Issue Date : 2023-05-23
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2004-209 - Rev 03
Status : Valid
Issue Date : 2020-03-04
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2003-130 - Rev 01
Status : Valid
Issue Date : 2011-12-12
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2006-279 - Rev 03
Status : Valid
Issue Date : 2014-07-28
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2003-053 - Rev 01
Status : Valid
Issue Date : 2011-08-22
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R0-CEP 2017-185 - Rev 00
Status : Expired
Issue Date : 2018-08-17
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2007-237 - Rev 02
Status : Valid
Issue Date : 2019-09-18
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R1-CEP 2009-319 - Rev 04
Status : Valid
Issue Date : 2019-09-16
Type : Chemical
Substance Number : 2016
Ondansetron Hydrochloride Dihydrate
Certificate Number : R0-CEP 2009-191 - Rev 02
Status : Expired
Issue Date : 2014-03-31
Type : Chemical
Substance Number : 2016
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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
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**
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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
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
DOSAGE - SOLUTION;ORAL - EQ 4MG BASE/5ML
USFDA APPLICATION NUMBER - 20605
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ABOUT THIS PAGE
A Ondansetron Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ondansetron Hydrochloride, including repackagers and relabelers. The FDA regulates Ondansetron Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ondansetron Hydrochloride 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 Ondansetron Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ondansetron Hydrochloride supplier is an individual or a company that provides Ondansetron Hydrochloride active pharmaceutical ingredient (API) or Ondansetron Hydrochloride finished formulations upon request. The Ondansetron Hydrochloride suppliers may include Ondansetron Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ondansetron Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ondansetron Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ondansetron Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ondansetron Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ondansetron Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ondansetron Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ondansetron Hydrochloride USDMF includes data on Ondansetron Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ondansetron Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Ondansetron Hydrochloride Drug Master File in Japan (Ondansetron Hydrochloride JDMF) empowers Ondansetron Hydrochloride 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 Ondansetron Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ondansetron Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ondansetron Hydrochloride Drug Master File in Korea (Ondansetron Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ondansetron Hydrochloride. The MFDS reviews the Ondansetron Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ondansetron Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ondansetron Hydrochloride 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 Ondansetron Hydrochloride API can apply through the Korea Drug Master File (KDMF).
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A Ondansetron Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Ondansetron Hydrochloride Certificate of Suitability (COS). The purpose of a Ondansetron Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ondansetron Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ondansetron Hydrochloride to their clients by showing that a Ondansetron Hydrochloride CEP has been issued for it. The manufacturer submits a Ondansetron Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ondansetron Hydrochloride CEP holder for the record. Additionally, the data presented in the Ondansetron Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ondansetron Hydrochloride DMF.
A Ondansetron Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ondansetron Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Ondansetron Hydrochloride written confirmation (Ondansetron Hydrochloride WC) is an official document issued by a regulatory agency to a Ondansetron Hydrochloride manufacturer, verifying that the manufacturing facility of a Ondansetron Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ondansetron Hydrochloride APIs or Ondansetron Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ondansetron Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Ondansetron Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
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 Ondansetron Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ondansetron Hydrochloride API and other APIs are published in this directory by the FDA.
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 Ondansetron Hydrochloride 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.
The NDC directory also contains data on finished compounded human drug products that contain Ondansetron Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ondansetron Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ondansetron Hydrochloride suppliers with NDC on PharmaCompass.
Ondansetron Hydrochloride 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 Ondansetron Hydrochloride 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 Ondansetron Hydrochloride GMP manufacturer or Ondansetron Hydrochloride GMP API supplier for your needs.
A Ondansetron Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ondansetron Hydrochloride's compliance with Ondansetron Hydrochloride specifications and serves as a tool for batch-level quality control.
Ondansetron Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ondansetron Hydrochloride 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.
Ondansetron Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ondansetron Hydrochloride EP), Ondansetron Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ondansetron Hydrochloride USP).
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