Composition: Ondansetron hydrochloride USP equivalent to anhydrous ondansetron 4 mg per uncoated ODT.
Usage: Prevention and treatment of nausea and vomiting in approved clinical settings; it does not trigger vomiting.
Category: Antacid & Anti Ulcer Drugs (website category)
Therapeutic category: Antiemetic / 5-HT3 receptor antagonist
SKU: Ondansetron Orally Disintegrating Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Ondansetron Orally Disintegrating Tablets USP 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 in certain settings, including chemotherapy, radiotherapy and surgery, subject to approved indications. The orally disintegrating dosage form is placed on the tongue, where it disperses without needing water; the medicine is then swallowed with saliva.
This listing covers the supplied USP 4 mg uncoated ODT. The 8 mg variant mentioned in the longer description has not been established by the provided product composition. Rapid tablet disintegration does not necessarily mean immediate clinical relief or faster absorption compared with conventional oral tablets.
| Product name | Ondansetron Orally Disintegrating Tablets |
|---|---|
| Active ingredient | Ondansetron hydrochloride USP equivalent to anhydrous ondansetron 4 mg |
| Confirmed strength | 4 mg (8 mg not confirmed in supplied composition) |
| Dosage form | Uncoated orally disintegrating tablet (ODT) |
| Pharmacopoeial standard | USP (BP / IP compliance not confirmed) |
| Therapeutic class | Antiemetic / selective 5-HT3 receptor antagonist |
| CAS number | 99614-01-4 (ondansetron free base; verify salt-specific identifiers) |
| Shelf life and packaging | Confirm against approved stability data and packaging specification |
Orally disintegrating tablet development requires a balance between rapid dispersion, mechanical integrity, palatability, moisture protection and dose uniformity. Suitable formulation approaches may use soluble excipients, disintegrants and taste-masking techniques. The specific excipients, flavours, disintegration time, processing humidity and blister construction for this product require confirmation from actual formulation and manufacturing records.
Product release and stability assessment should follow the applicable approved USP specification, including identity, assay, uniformity, disintegration or dissolution as relevant, related substances and packaging integrity. Do not assume a 30-second disintegration limit, 90–110% assay range or 36-month shelf life without the product-specific approved specification and stability results.
Ondansetron selectively blocks 5-HT3 receptors involved in the vomiting reflex, helping prevent nausea and vomiting associated with certain cancer treatments and postoperative care. Indications and age eligibility vary by jurisdiction and approved product labeling. ODT convenience may help patients who have difficulty swallowing standard tablets, but it is not guaranteed to act more rapidly or to treat every cause of vomiting.
Business customers should request product-specific manufacturing authorization, GMP evidence, approved artwork, certificate of analysis, validated stability data, and any required CTD/ACTD documentation. Availability of FSC, COPP, dossiers, export permissions and shipping arrangements should be verified with the supplier before publication or procurement.
Q: Which strength is confirmed?
A: The supplied formula confirms 4 mg USP ODT. An 8 mg version is not verified here.
Q: Does the tablet need water?
A: Usually no. Place it on the tongue and allow it to disperse, then swallow with saliva, following the approved pack instructions.
Q: Should the tablet be pushed through the blister?
A: Some fragile ODT products require peeling back the foil. Follow the exact packaging instructions; do not assume every blister opens the same way.
Q: Is it suitable for all vomiting?
A: No. Persistent vomiting, dehydration, severe abdominal pain or other warning symptoms require medical assessment.
For registered medical practitioners and patient reference; follow locally approved prescribing information.
Ondansetron dosing depends on the indication, age, chemotherapy emetogenicity, concomitant medicines and liver function. Severe hepatic impairment may require a lower maximum daily dose under applicable labeling. With dry hands, remove the ODT as instructed on the pack, place on the tongue, let it disperse and swallow. Do not use promotional dose schedules in place of prescribing information.
Common adverse effects include headache and constipation. Important precautions include QT interval prolongation and serious heart rhythm disturbances, serotonin syndrome when used with certain serotonergic medicines, hypersensitivity and masking of progressive ileus. Correct electrolyte abnormalities and review interactions when clinically relevant. Ondansetron is contraindicated with apomorphine in jurisdictions where this interaction is listed. Some ODT products contain phenylalanine from aspartame; check the actual excipient label for patients with phenylketonuria.
Store according to the approved label in original packaging and protect from moisture and excessive heat. The exact temperature limit and expiry date must be supported by stability studies. Handle fragile ODT tablets carefully and open the blister only when ready to administer.