Composition: Ondansetron hydrochloride (as specified for IP/BP/USP variants), equivalent to anhydrous Ondansetron 4 mg or 8 mg.
Usage: Prevention and control of nausea and vomiting in approved settings.
Category: Antacid & Anti Ulcer Drugs (website category)
Therapeutic category: Antiemetic / 5-HT3 receptor antagonist
SKU: Ondansetron Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Ondansetron Tablets is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (manufacturing and WHO-GMP certification subject to verification)
Exporter: Healthy Inc (export credentials subject to verification)
Ondansetron is a selective serotonin 5-HT3 receptor antagonist used to prevent nausea and vomiting associated with chemotherapy, radiotherapy and surgery in approved clinical settings. It blocks serotonin-mediated signals involved in the vomiting reflex.
This product listing covers conventional uncoated oral tablets, not orally disintegrating (ODT/MD) tablets. The supplied variants include 4 mg and 8 mg products under different pharmacopoeial standards. The exact registered indications vary by country and label.
| Variant | Strength | Composition / Standard | Dosage form |
|---|---|---|---|
| Ondansetron Tablets IP | 4 mg | Ondansetron Hydrochloride Dihydrate IP equivalent to anhydrous Ondansetron 4 mg | Uncoated oral tablet |
| Xysetron | 4 mg | Ondansetron Hydrochloride USP equivalent to anhydrous Ondansetron 4 mg | Uncoated oral tablet |
| Nausedon 4 | 4 mg | Ondansetron HCl Dihydrate BP equivalent to anhydrous Ondansetron 4 mg | Uncoated oral tablet |
| Xysetron 8 | 8 mg | Ondansetron Hydrochloride USP equivalent to anhydrous Ondansetron 8 mg | Uncoated oral tablet |
| Nausedon 8 | 8 mg | Ondansetron HCl Dihydrate BP equivalent to anhydrous Ondansetron 8 mg | Uncoated oral tablet |
Therapeutic class: Antiemetic / 5-HT3 receptor antagonist. CAS: 99614-01-4 (ondansetron free base; salt identifiers differ). Shelf life and packaging require confirmation from approved product records.
Conventional oral tablet development focuses on blend uniformity, tablet integrity, consistent disintegration, dissolution, and stability. Excipients and manufacturing processes should be selected and validated against the applicable pharmacopoeial monograph and approved specifications.
The supplied products are uncoated tablets. Claims regarding ODT technology, taste-masking resins, flavouring, sub-30-second dispersion, special humidity-controlled rooms or Alu-Alu blister construction are not established for these variants.
Appropriate quality controls include identity, assay, content uniformity, dissolution or disintegration as applicable, related substances, microbiological requirements where applicable, and stability in the final market pack. Specific numerical acceptance criteria must be taken from the relevant approved IP, BP or USP monograph and product specification rather than assumed across all variants.
Ondansetron selectively antagonizes 5-HT3 receptors in the gastrointestinal tract and central nervous system, helping prevent chemotherapy-induced, radiotherapy-induced and postoperative nausea and vomiting where approved.
It prevents or controls nausea and vomiting; it does not trigger them. Pregnancy-related nausea is not an automatically approved indication and requires individual risk–benefit assessment. It is not a universal treatment for every cause of vomiting.
For importers and B2B partners, applicable requirements may include a product dossier (CTD/ACTD where accepted), manufacturing authorization, Certificate of Analysis, stability data, approved artwork and export documentation. Availability of WHO-GMP certification, COPP, FSC, specific dossiers and destination-country registrations should be confirmed directly before advertising or tender submission.
Q: Are these mouth-dissolving tablets?
A: No. The supplied compositions identify conventional uncoated tablets. ODTs are a separate dosage form.
Q: Which strengths are confirmed?
A: Both 4 mg and 8 mg are supplied, with IP, BP and USP variants as listed above.
Q: Does ondansetron make patients vomit?
A: No. It is an antiemetic used to prevent or control nausea and vomiting.
Q: Is it safe during pregnancy?
A: Use during pregnancy requires clinician-led assessment of benefits and risks; it should not be described as universally safe.
Swallow conventional oral tablets with water, as directed in the approved prescribing information. The dose, timing and duration depend on the clinical indication, patient age, liver function, concomitant medicines and local labeling. Patients with severe hepatic impairment may require a lower maximum total daily dose. These tablets are not intended to dissolve on the tongue like ODT formulations.
Common adverse effects include headache and constipation. Important precautions include QT interval prolongation and potentially serious arrhythmias, particularly in patients with electrolyte disturbances, congenital long QT syndrome or other QT-prolonging medicines. Serotonin syndrome has been reported, especially with other serotonergic drugs. Ondansetron is contraindicated with apomorphine. Clinicians should review allergies, other medicines and relevant medical history before prescribing.
Store in accordance with the approved product label, in the original packaging and protected from unsuitable heat, moisture and light. A universal temperature limit or 36-month shelf life cannot be confirmed from the supplied composition alone. Keep out of reach of children.