Label: ONDANSETRON HYDROCHLORIDE tablet, film coated
ONDANSETRON tablet, orally disintegrating

  • NDC Code(s): 62756-130-01, 62756-130-02, 62756-131-01, 62756-131-02, view more
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 18, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE TABLETS, and ONDANSETRON ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Ondansetron is indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. initial and ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage - The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively. Corresponding doses of ondansetron tablets, ondansetron orally ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Ondansetron tablets are oval, film-coated tablets available in the following strengths: 4 mg – white tablet with “130” engraved on one side. 8 mg – yellow tablet with “131” engraved on one ...
  • 4 CONTRAINDICATIONS
    Ondansetron is contraindicated in patients:   known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypersensitivity Reactions - Hypersensitivity reactions, including anaphylaxis and bronchospasm, have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] QT Prolongation [see Warnings ...
  • 7 DRUG INTERACTIONS
    7.1 Serotonergic Drugs - Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important ...
  • 9 DRUG ABUSE AND DEPENDENCE
    Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.
  • 10 OVERDOSAGE
    There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. In addition to the adverse reactions listed above, the following adverse ...
  • 11 DESCRIPTION
    The active ingredient in ondansetron tablets is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Ondansetron is a selective 5-HT3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron doses up to 10 mg/kg per day and 30 mg/kg ...
  • 14 CLINICAL STUDIES
    14.1 Prevention of Chemotherapy-Induced Nausea and Vomiting - Highly Emetogenic Chemotherapy - In 2 randomized, double-blind, monotherapy trials, a single 24 mg oral dose of ondansetron was ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Ondansetron Tablets - 4 mg (ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with “130” on one side and plain on the other ...
  • 17 PATIENT COUNSELING INFORMATION
    Hypersensitivity Reactions - Inform patients that ondansetron may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. Instruct patients to immediately report any ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Ondansetron Hydrochloride Tablets
    NDC 62756-130-01 - Ondansetron Hydrochloride Tablets - 4 mg* Rx only - 30 Tablets - SUN PHARMA - NDC 62756-131-01 - Ondansetron Hydrochloride Tablets - 8 mg* Rx only - 30 Tablets - SUN PHARMA - NDC ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Ondansetron Orally Disintegrating Tablets
    NDC 62756-240-83 - Ondansetron Orally Disintegrating Tablets, USP - 4 mg - Rx only - 30 Tablets - SUN PHARMA - NDC 62756-356-83 - Ondansetron Orally Disintegrating Tablets, USP - 8 mg - Rx only - 30 ...
  • INGREDIENTS AND APPEARANCE
    Product Information