Medicine
Ondansetron 8 mg orally disintegrating tablet
Ondansetron 8 mg orally disintegrating tablet is a generic prescription medicine for oral use, made by 24 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25° C (68°F to 77° F).
Key facts
- Active ingredient (INN)
- Ondansetron
- Brand
- Sold under the generic name
- Strength
- 8 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 1 blister pack, 100 tablets, 500 tablets and 166 more
- Manufacturers
- Aurobindo PharmaIndiaIpca LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaGlenmark PharmaceuticalsIndiaBryant Ranch PrepackNuCare Pharmaceuticals,IncRising Pharma HoldingsChartwell RX24 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25° C (68°F to 77° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A04AA01 Ondansetron
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 December 2006
- Identifiers
- RxCUI 312087, 104894, 2685489 +3DailyMed set ID 40258e4b-5e67-46c0-8ef0-3e8bfe36ba11, e436e361-da0f-7d6d-e053-2995a90a10e4, f1a0ea2c-0788-4e8a-e053-2a95a90a2f32 +37NDC 71335-2974, 76420-251, 80425-0222 +37Application ANDA209389, ANDA090469, ANDA078152 +2
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 24 labelers. The register lists 169 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 65862-391-01 | Aurobindo PharmaIndia | 24 March 2021 |
| 100 tablet, orally disintegrating in 1 bottle | 65862-391-02 | Aurobindo PharmaIndia | 12 April 2024 |
| 500 tablet, orally disintegrating in 1 bottle | 65862-391-05 | Aurobindo PharmaIndia | 12 April 2024 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 65862-391-10 | Aurobindo PharmaIndia | 12 April 2010 |
| 30 tablet, orally disintegrating in 1 bottle | 65862-391-30 | Aurobindo PharmaIndia | 12 April 2010 |
| 6000 tablet, orally disintegrating in 1 bottle | 65862-391-66 | Aurobindo PharmaIndia | 12 April 2010 |
| 10 tablet, orally disintegrating in 1 box, unit-dose | 68462-158-11 | Glenmark PharmaceuticalsIndia | 27 June 2007 |
| 30 tablet, orally disintegrating in 1 box, unit-dose | 68462-158-13 | Glenmark PharmaceuticalsIndia | 27 June 2007 |
| 100 tablet, orally disintegrating in 1 bottle | 83980-013-01 | Ipca LaboratoriesIndia | 19 June 2025 |
| 1000 tablet, orally disintegrating in 1 bottle | 83980-013-10 | Ipca LaboratoriesIndia | 19 June 2025 |
| 30 tablet, orally disintegrating in 1 bottle | 83980-013-13 | Ipca LaboratoriesIndia | 19 June 2025 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 83980-013-83 | Ipca LaboratoriesIndia | 19 June 2025 |
| 3 blister pack in 1 dose pack / 10 tablet, orally disintegrating in 1 blister pack | 62756-356-64 | Sun Pharmaceutical IndustriesIndia | 2 August 2007 |
| 1 blister pack in 1 dose pack / 10 tablet, orally disintegrating in 1 blister pack | 62756-356-66 | Sun Pharmaceutical IndustriesIndia | 2 August 2007 |
| 30 tablet, orally disintegrating in 1 bottle | 62756-356-83 | Sun Pharmaceutical IndustriesIndia | 2 August 2007 |
| 30 tablet, orally disintegrating in 1 bottle | 62135-122-30 | Chartwell RX | 30 March 2022 |
| 100 tablet, orally disintegrating in 1 bottle | 57237-078-01 | Rising Pharma Holdings | 30 September 2024 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 57237-078-10 | Rising Pharma Holdings | 12 April 2010 |
| 30 tablet, orally disintegrating in 1 bottle | 57237-078-30 | Rising Pharma Holdings | 12 April 2010 |
| 500 tablet, orally disintegrating in 1 bottle | 57237-078-50 | Rising Pharma Holdings | 30 September 2024 |
| 30 tablet, orally disintegrating in 1 bottle | 68071-1730-3 | NuCare Pharmaceuticals,Inc | 8 August 2018 |
| 30 blister pack in 1 dose pack / 10 tablet, orally disintegrating in 1 blister pack | 68071-2284-3 | NuCare Pharmaceuticals,Inc | 26 October 2020 |
| 10 tablet, orally disintegrating in 1 box, unit-dose | 68071-2718-1 | NuCare Pharmaceuticals,Inc | 20 May 2022 |
| 30 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 68071-2763-3 | NuCare Pharmaceuticals,Inc | 15 June 2022 |
| 30 tablet, orally disintegrating in 1 box, unit-dose | 68071-3926-3 | NuCare Pharmaceuticals,Inc | 8 December 2025 |
| 30 tablet, orally disintegrating in 1 box | 68071-4570-3 | NuCare Pharmaceuticals,Inc | 21 September 2018 |
| 4 tablet, orally disintegrating in 1 box | 68071-5167-4 | NuCare Pharmaceuticals,Inc | 7 February 2020 |
| 15 tablet, orally disintegrating in 1 box | 68071-5167-5 | NuCare Pharmaceuticals,Inc | 27 January 2026 |
| 10 tablet, orally disintegrating in 1 box | 68071-5230-1 | NuCare Pharmaceuticals,Inc | 27 March 2020 |
| 3 tablet, orally disintegrating in 1 blister pack | 63629-4306-0 | Bryant Ranch Prepack | 20 August 2010 |
| 30 tablet, orally disintegrating in 1 blister pack | 63629-4306-1 | Bryant Ranch Prepack | 19 August 2013 |
| 10 tablet, orally disintegrating in 1 blister pack | 63629-4306-2 | Bryant Ranch Prepack | 19 August 2013 |
| 5 tablet, orally disintegrating in 1 blister pack | 63629-4306-3 | Bryant Ranch Prepack | 19 August 2013 |
| 4 tablet, orally disintegrating in 1 blister pack | 63629-4306-4 | Bryant Ranch Prepack | 20 August 2010 |
| 6 tablet, orally disintegrating in 1 blister pack | 63629-4306-5 | Bryant Ranch Prepack | 20 August 2010 |
| 14 tablet, orally disintegrating in 1 blister pack | 63629-4306-6 | Bryant Ranch Prepack | 20 August 2010 |
| 60 tablet, orally disintegrating in 1 blister pack | 63629-4306-7 | Bryant Ranch Prepack | 20 August 2010 |
| 12 tablet, orally disintegrating in 1 blister pack | 63629-4306-8 | Bryant Ranch Prepack | 20 August 2010 |
| 90 tablet, orally disintegrating in 1 blister pack | 63629-4306-9 | Bryant Ranch Prepack | 20 August 2010 |
| 3 tablet, orally disintegrating in 1 bottle | 71335-1071-0 | Bryant Ranch Prepack | 2 May 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 4 January 1991 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Ondansetron
Clinical summary
Ondansetron is a serotonin-3 receptor antagonist. It is available as tablets, orally disintegrating tablets and injection for intramuscular and intravenous use. MedsAcross supplies Ondansetron for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about OndansetronFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ondansetron prescribing information (Ascend Laboratories) · U.S. National Library of Medicine, DailyMed
Need Ondansetron 8 mg orally disintegrating tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.