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Drug ReportsOndansetron
Ondansetron
Ondansetron (ondansetron) is a small molecule pharmaceutical. Ondansetron was first approved as Zofran on 1991-01-04. It is used to treat alcoholism in the USA.
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Drug
Target
Variants
Financial
Trends
Safety
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
chemically-induced disordersD064419
mental disordersD001523
Trade Name
FDA
EMA
Ondansetron (discontinued: Ondansetron, Zofran, Zuplenz)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ondansetron hydrochloride
Tradename
Company
Number
Date
Products
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERGSKN-020403 DISCN1995-01-31
1 products, RLD
ZOFRANSandozN-020007 DISCN1991-01-04
1 products, RLD
ZOFRAN PRESERVATIVE FREESandozN-020007 DISCN1993-12-10
1 products, RLD
ZOFRANSandozN-020103 DISCN1992-12-31
3 products, RLD
ZOFRANSandozN-020605 DISCN1997-01-24
1 products, RLD
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Ondansetron
Tradename
Company
Number
Date
Products
ZUPLENZAquestive TherapeuticsN-022524 DISCN2010-07-02
2 products, RLD
ZOFRAN ODTSandozN-020781 DISCN1999-01-27
2 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
mko melt dose packunapproved drug other2019-03-04
ondansetronANDA2025-03-27
ondansetron hclANDA2024-12-31
ondansetron hydrochlorideANDA2025-04-03
ondansetron hydrochloride ondansetron hydrochlorideANDA2025-01-27
ondansetron ondansetron hydrochlorideANDA2024-05-30
sumansetronunapproved drug other2023-01-11
zofranANDA2021-10-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
alcoholismEFO_0003829D000437F10.1
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ondansetron, Zuplenz, Aquestive
90955772030-07-13DP
85808302029-11-23DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A04: Antiemetics and antinauseants
— A04A: Antiemetics and antinauseants
— A04AA: Serotonin (5ht3) antagonists
— A04AA01: Ondansetron
HCPCS
Code
Description
J2405
Injection, ondansetron hydrochloride, per 1 mg
Q0162
Ondansetron 1 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen
S0119
Ondansetron, oral, 4 mg (for circumstances falling under the medicare statute, use hcpcs q code)
Clinical
Clinical Trials
590 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80—1———1
NauseaD009325—R11.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOndansetron
INNondansetron
Description
Ondansetron is a member of carbazoles.
Classification
Small molecule
Drug classserotonin 5-HT3 receptor antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Identifiers
PDB—
CAS-ID99614-02-5
RxCUI—
ChEMBL IDCHEMBL46
ChEBI ID7773
PubChem CID4595
DrugBankDB00904
UNII ID4AF302ESOS (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Zuplenz – Par Pharmaceutical
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Estimated US medical usage
Ondansetron
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 15,917 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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27,464 adverse events reported
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