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Ondansetron
Zofran, Zuplenz (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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
chemically-induced disordersD064419
mental disordersD001523
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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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Ondansetron hydrochloride
Tradename
Company
Number
Date
Products
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERGSKN-020403 DISCN1995-01-31
1 products, RLD
ZOFRAN PRESERVATIVE FREESandozN-020007 DISCN1993-12-10
1 products, RLD
ZOFRANSandozN-020007 DISCN1991-01-04
1 products, RLD
ZOFRANSandozN-020103 DISCN1992-12-31
3 products, RLD
ZOFRANSandozN-020605 DISCN1997-01-24
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
ondansetron hydrochlorideANDA2023-05-16
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
259 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544——1022638
Urinary tract infectionsD014552EFO_0003103N39.0—286—16
Healthy volunteers/patients—61—3111
PneumoniaD011014EFO_0003106J18—281—10
CataractD002386EFO_0001059H26.93114—9
Multidrug-resistant tuberculosisD018088EFO_0007381—451—9
EndophthalmitisD00987733—115
Pulmonary tuberculosisD014397EFO_1000049A15—122—4
Pelvic inflammatory diseaseD000292EFO_1001388N70-N77——22—4
Otitis mediaD010033EFO_0004992H66.9——31—4
Show 27 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PyelonephritisD011704EFO_1001141N10-N16—25——7
TuberculosisD014376EFO_0000774A15-A19223—16
Hiv infectionsD015658EFO_0000764B202—1—25
Chronic bronchitisD029481J42—15——5
ProstatitisD011472EFO_0003830N41—14——5
Diabetic footD017719EFO_1001459—32——5
Bacterial infectionsD001424A491—3——4
NeoplasmsD009369C80—23——4
Cystic fibrosisD003550EFO_0000390E842—2——4
Maxillary sinusitisD015523EFO_0007361J32.0——3——3
Show 45 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MyopiaD009216H52.111——12
SarcoidosisD012507EFO_0000690D80-D89—1———1
Non-hodgkin lymphomaD008228C85.9—1———1
PterygiumD011625H11.011———1
Corneal diseasesD003316H18.911———1
HyperopiaD006956H52.011———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pulmonary sarcoidosisD017565DOID_13406D86.01————1
Retinal diseasesD012164HP_0000479H35.91————1
Hearing lossD034381EFO_0004238H91.91————1
Escherichia coli infectionsD004927EFO_1001318B96.201————1
Short bowel syndromeD0127781————1
PharmacokineticsD0105991————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805A41.9————22
MicrobiotaD064307————11
Chemical and drug induced liver injuryD056486————11
Refractive errorsD012030EFO_0003908H52.7————11
TherapeuticsD013812————11
Helicobacter pyloriD016480NCBITaxon_210B96.81————11
RadiotherapyD011878————11
Drug-related side effects and adverse reactionsD064420T88.7————11
Drug monitoringD016903————11
EpistaxisD004844EFO_0003895R04.0————11
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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)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Zuplenz - Par Pharmaceutical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,742 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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80,293 adverse events reported
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