Medicine
Ondansetron 4 mg orally disintegrating tablet
Ondansetron 4 mg orally disintegrating tablet is a generic prescription medicine for oral use, made by 25 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
- 4 mg
- Dosage form
- Orally disintegrating tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 3 blister pack and 171 more
- Manufacturers
- Aurobindo PharmaIndiaIpca LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaGlenmark PharmaceuticalsIndiaNuCare Pharmaceuticals,IncA-S Medication SolutionsRising Pharma HoldingsChartwell RX25 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).
- 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 104894, 312087, 198052 +3DailyMed set ID b76c5cc9-f1ca-428b-8989-36a66802b650, 251d7b9a-f935-42f7-b985-91b8bba7637b, 02ddd5f5-76d3-4f1c-9af3-d39e05a19c29 +37NDC 85534-0025, 50090-1201, 50090-1659 +37Application ANDA090469, ANDA078152, ANDA077557 +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 25 labelers. The register lists 174 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, orally disintegrating in 1 bottle | 65862-390-02 | Aurobindo PharmaIndia | 12 April 2024 |
| 500 tablet, orally disintegrating in 1 bottle | 65862-390-05 | Aurobindo PharmaIndia | 12 April 2024 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 65862-390-10 | Aurobindo PharmaIndia | 12 April 2010 |
| 10000 tablet, orally disintegrating in 1 bottle | 65862-390-19 | Aurobindo PharmaIndia | 12 April 2010 |
| 30 tablet, orally disintegrating in 1 bottle | 65862-390-30 | Aurobindo PharmaIndia | 12 April 2010 |
| 30 tablet, orally disintegrating in 1 box, unit-dose | 68462-157-13 | Glenmark PharmaceuticalsIndia | 27 June 2007 |
| 100 tablet, orally disintegrating in 1 bottle | 83980-012-01 | Ipca LaboratoriesIndia | 19 June 2025 |
| 1000 tablet, orally disintegrating in 1 bottle | 83980-012-10 | Ipca LaboratoriesIndia | 19 June 2025 |
| 30 tablet, orally disintegrating in 1 bottle | 83980-012-13 | Ipca LaboratoriesIndia | 19 June 2025 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 83980-012-83 | Ipca LaboratoriesIndia | 19 June 2025 |
| 3 blister pack in 1 dose pack / 10 tablet, orally disintegrating in 1 blister pack | 62756-240-64 | Sun Pharmaceutical IndustriesIndia | 2 August 2007 |
| 30 tablet, orally disintegrating in 1 bottle | 62756-240-83 | Sun Pharmaceutical IndustriesIndia | 2 August 2007 |
| 30 tablet, orally disintegrating in 1 bottle | 62135-121-30 | Chartwell RX | 30 March 2022 |
| 100 tablet, orally disintegrating in 1 bottle | 57237-077-01 | Rising Pharma Holdings | 30 September 2024 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 57237-077-10 | Rising Pharma Holdings | 12 April 2010 |
| 30 tablet, orally disintegrating in 1 bottle | 57237-077-30 | Rising Pharma Holdings | 12 April 2010 |
| 500 tablet, orally disintegrating in 1 bottle | 57237-077-50 | Rising Pharma Holdings | 30 September 2024 |
| 30 tablet, orally disintegrating in 1 box, unit-dose | 68071-2901-3 | NuCare Pharmaceuticals,Inc | 9 December 2022 |
| 10 tablet, orally disintegrating in 1 bottle | 68071-3268-1 | NuCare Pharmaceuticals | 23 May 2017 |
| 2 tablet, orally disintegrating in 1 bottle | 68071-3268-2 | NuCare Pharmaceuticals | 23 May 2017 |
| 3 tablet, orally disintegrating in 1 bottle | 68071-3268-3 | NuCare Pharmaceuticals | 23 May 2017 |
| 4 tablet, orally disintegrating in 1 bottle | 68071-3268-4 | NuCare Pharmaceuticals | 23 May 2017 |
| 5 tablet, orally disintegrating in 1 bottle | 68071-3268-5 | NuCare Pharmaceuticals | 23 May 2017 |
| 6 tablet, orally disintegrating in 1 bottle | 68071-3268-6 | NuCare Pharmaceuticals | 23 May 2017 |
| 20 tablet, orally disintegrating in 1 bottle | 68071-3268-7 | NuCare Pharmaceuticals | 23 May 2017 |
| 2 tablet, orally disintegrating in 1 bottle | 68071-4115-2 | NuCare Pharmaceuticals,Inc | 16 October 2017 |
| 3 tablet, orally disintegrating in 1 bottle | 68071-4115-3 | NuCare Pharmaceuticals,Inc | 27 June 2023 |
| 4 tablet, orally disintegrating in 1 bottle | 68071-4115-4 | NuCare Pharmaceuticals,Inc | 16 October 2017 |
| 10 tablet, orally disintegrating in 1 box | 68071-4834-1 | NuCare Pharmaceuticals,Inc | 5 April 2019 |
| 2 tablet, orally disintegrating in 1 box | 68071-4834-2 | NuCare Pharmaceuticals,Inc | 5 April 2019 |
| 4 tablet, orally disintegrating in 1 box | 68071-4834-4 | NuCare Pharmaceuticals,Inc | 5 April 2019 |
| 6 tablet, orally disintegrating in 1 box | 68071-4834-6 | NuCare Pharmaceuticals,Inc | 5 April 2019 |
| 20 tablet, orally disintegrating in 1 box | 68071-4834-7 | NuCare Pharmaceuticals,Inc | 5 April 2019 |
| 2 tablet, orally disintegrating in 1 blister pack | 68071-4881-2 | NuCare Pharmaceuticals,Inc | 3 May 2019 |
| 4 tablet, orally disintegrating in 1 blister pack | 68071-4881-4 | NuCare Pharmaceuticals,Inc | 3 May 2019 |
| 10 tablet, orally disintegrating in 1 blister pack | 68071-5021-3 | NuCare Pharmaceuticals,Inc | 8 August 2019 |
| 1 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 50090-1200-0 | A-S Medication Solutions | 28 November 2014 |
| 1 blister pack in 1 carton / 20 tablet, orally disintegrating in 1 blister pack | 50090-1200-1 | A-S Medication Solutions | 28 November 2014 |
| 1 blister pack in 1 carton / 5 tablet, orally disintegrating in 1 blister pack | 50090-1200-2 | A-S Medication Solutions | 28 November 2014 |
| 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack | 50090-1200-3 | A-S Medication Solutions | 17 January 2017 |
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 4 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.