Medicine
Ondansetron 8 mg tablet
Ondansetron 8 mg tablet is a generic prescription medicine for oral use, made by 33 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° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Ondansetron
- Brand
- Sold under the generic name
- Strength
- 8 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 156 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaNatco PharmaIndiaIpca LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaGlenmark PharmaceuticalsIndiaAscend LaboratoriesIndiaNuCare Pharmaceuticals,IncPharmPakChartwell RX33 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
- 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 312086, 198052, 312084 +2DailyMed set ID 54e8981e-6880-4d4f-bc46-600c2af59698, 00b17a8e-9d38-a8d4-e063-6294a90a153e, bde7c22c-0047-4735-8df6-b48e8dfa478a +37NDC 55700-627, 60760-658, 63187-513 +37Application ANDA078539, ANDA077851, ANDA077050 +4
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 33 labelers. The register lists 159 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 63850-0004-1 | Natco PharmaIndia | 25 June 2007 |
| 100 tablet in 1 bottle | 69339-172-01 | Natco PharmaIndia | 27 June 2025 |
| 30 tablet in 1 bottle | 69339-172-03 | Natco PharmaIndia | 24 October 2022 |
| 500 tablet in 1 bottle | 69339-172-05 | Natco PharmaIndia | 27 June 2025 |
| 30 tablet, film coated in 1 bottle | 62756-131-01 | Sun Pharmaceutical IndustriesIndia | 25 June 2007 |
| 10 blister pack in 1 dose pack / 10 tablet, film coated in 1 blister pack | 62756-131-02 | Sun Pharmaceutical IndustriesIndia | 25 June 2007 |
| 30 tablet, film coated in 1 bottle | 63304-459-30 | Sun Pharmaceutical IndustriesIndia | 25 June 2007 |
| 30 tablet, film coated in 1 bottle | 67877-170-30 | Ascend LaboratoriesIndia | 6 January 2007 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 65862-188-03 | Aurobindo PharmaIndia | 31 July 2007 |
| 500 tablet, film coated in 1 bottle | 65862-188-05 | Aurobindo PharmaIndia | 31 July 2007 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-188-10 | Aurobindo PharmaIndia | 31 July 2007 |
| 30 tablet, film coated in 1 bottle | 65862-188-30 | Aurobindo PharmaIndia | 31 July 2007 |
| 1000 tablet, film coated in 1 bottle | 65862-188-99 | Aurobindo PharmaIndia | 31 July 2007 |
| 100 tablet, film coated in 1 bottle | 55111-154-01 | Dr. Reddy's LaboratoriesIndia | 26 December 2006 |
| 500 tablet, film coated in 1 bottle | 55111-154-05 | Dr. Reddy's LaboratoriesIndia | 26 December 2006 |
| 3 dose pack in 1 box / 1 tablet, film coated in 1 dose pack | 55111-154-13 | Dr. Reddy's LaboratoriesIndia | 26 December 2006 |
| 30 tablet, film coated in 1 bottle | 55111-154-30 | Dr. Reddy's LaboratoriesIndia | 26 December 2006 |
| 10 dose pack in 1 box / 10 tablet, film coated in 1 dose pack | 55111-154-78 | Dr. Reddy's LaboratoriesIndia | 26 December 2006 |
| 30 tablet, film coated in 1 bottle | 68462-106-30 | Glenmark PharmaceuticalsIndia | 25 June 2007 |
| 1 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack | 68462-106-33 | Glenmark PharmaceuticalsIndia | 25 June 2007 |
| 1000 tablet, film coated in 1 bottle | 83980-018-10 | Ipca LaboratoriesIndia | 14 August 2026 |
| 30 tablet, film coated in 1 bottle | 83980-018-13 | Ipca LaboratoriesIndia | 14 August 2026 |
| 10 tablet, film coated in 1 bottle | 83980-018-97 | Ipca LaboratoriesIndia | 14 August 2026 |
| 500 tablet in 1 bottle | 62135-351-05 | Chartwell RX | 20 April 2022 |
| 30 tablet in 1 bottle | 62135-351-30 | Chartwell RX | 20 April 2022 |
| 1 bottle in 1 box / 1 tablet, film coated in 1 bottle | 54348-821-00 | Pharmpak | 8 August 2019 |
| 1 bottle in 1 box / 2 tablet, film coated in 1 bottle | 54348-821-02 | Pharmpak | 8 August 2019 |
| 1 bottle in 1 box / 4 tablet, film coated in 1 bottle | 54348-821-04 | Pharmpak | 8 August 2019 |
| 1 bottle in 1 box / 5 tablet, film coated in 1 bottle | 54348-821-05 | Pharmpak | 8 August 2019 |
| 30 tablet, film coated in 1 bottle | 57237-076-30 | Rising Pharma Holdings | 31 July 2007 |
| 500 tablet, film coated in 1 bottle | 57237-076-50 | Rising Pharma Holdings | 4 October 2022 |
| 30 tablet, film coated in 1 bottle | 68071-1742-3 | NuCare Pharmaceuticals,Inc | 6 April 2023 |
| 30 tablet, film coated in 1 bottle | 68071-3713-3 | NuCare Pharmaceuticals | 25 October 2024 |
| 10 tablet, film coated in 1 bottle | 68071-3801-1 | NuCare Pharmaceuticals | 24 February 2025 |
| 10 tablet, film coated in 1 bottle | 68071-4328-1 | NuCare Pharmceuticals,Inc | 12 March 2018 |
| 4 tablet, film coated in 1 bottle | 68071-4328-4 | NuCare Pharmceuticals,Inc | 12 March 2018 |
| 4 tablet, film coated in 1 bottle | 68071-4705-4 | NuCare Pharmaceuticals,Inc | 11 January 2019 |
| 4 tablet, film coated in 1 bottle | 68071-4966-4 | Nucare Pharmaceuticals | 11 July 2019 |
| 10 tablet, film coated in 1 bottle | 63187-065-10 | Proficient Rx | 1 April 2014 |
| 15 tablet, film coated in 1 bottle | 63187-065-15 | Proficient Rx | 1 April 2014 |
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 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.