Medicine
Ondansetron 4 mg/5 mL oral solution
Ondansetron 4 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 13 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). Protect from light. Store bottles…
Key facts
- Active ingredient (INN)
- Ondansetron
- Brand
- Sold under the generic name
- Strength
- 4 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 50 mL, 3 trays and 23 more
- Manufacturers
- Aurobindo PharmaIndiaAtlantic BiologicalsAtlantic BiologicsAmneal PharmaceuticalsChartwell RXPAI PharmaAmerican Health PackagingAvPAKChartwell Governmental & Specialty RXHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Protect from light. Store bottles upright in cartons.
- 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 312085DailyMed set ID 68a4d845-0c1c-4867-bfca-c0fb11dc93cd, 2086bae8-7c3c-4663-93ac-c86407c524c2, 04800a86-2391-44e6-8763-d65e8a916c26 +10NDC 0121-0882, 0121-4882, 62135-555 +11Application ANDA078127, ANDA091342, ANDA076960 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 50 mL in 1 bottle, plastic | 65862-208-04 | Aurobindo PharmaIndia | 28 November 2007 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 65862-208-50 | Aurobindo PharmaIndia | 28 November 2007 |
| 50 mL in 1 bottle, plastic | 0121-0882-51 | PAI Pharma | 20 April 2026 |
| 3 tray in 1 case / 10 cup in 1 tray / 5 mL in 1 cup | 0121-4882-94 | PAI Pharma | 9 June 2026 |
| 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 65162-691-19 | Amneal Pharmaceuticals | 17 December 2010 |
| 50 mL in 1 bottle | 65162-691-79 | Amneal Pharmaceuticals | 17 December 2010 |
| 60 syringe in 1 case / 2.5 mL in 1 syringe | 17856-0672-1 | Atlantic Biologics | 23 October 2025 |
| 120 syringe in 1 case / 2.5 mL in 1 syringe | 17856-0672-2 | Atlantic Biologics | 23 October 2025 |
| 120 syringe in 1 case / 2.5 mL in 1 syringe | 17856-0672-3 | Atlantic Biologics | 23 October 2025 |
| 72 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 17856-0672-4 | Atlantic Biologics | 23 October 2025 |
| 2 tray in 1 box / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 68999-555-24 | Chartwell Governmental & Specialty RX | 6 January 2026 |
| 2 tray in 1 box / 10 package in 1 tray / 5 mL in 1 package | 62135-555-24 | Chartwell RX | 28 May 2024 |
| 50 mL in 1 bottle | 62135-555-58 | Chartwell RX | 4 October 2022 |
| 1 bottle, glass in 1 carton / 50 mL in 1 bottle, glass | 0054-0064-47 | Hikma Pharmaceuticals | 26 December 2006 |
| 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-252-86 | American Health Packaging | 5 February 2019 |
| 1.5 mL in 1 syringe | 17856-0691-1 | Atlantic Biologicals | 17 April 2024 |
| 2.5 mL in 1 syringe, plastic | 17856-0691-2 | Atlantic Biologicals | 17 April 2024 |
| 2.5 mL in 1 syringe, plastic | 17856-0691-4 | Atlantic Biologicals | 17 April 2024 |
| 5 mL in 1 cup | 17856-0691-5 | Atlantic Biologicals | 17 April 2024 |
| 120 syringe in 1 box, unit-dose / 1.25 mL in 1 syringe | 17856-0691-6 | Atlantic Biologicals | 17 April 2024 |
| 48 syringe in 1 box, unit-dose / 1.9 mL in 1 syringe | 17856-0691-7 | Atlantic Biologicals | 17 April 2024 |
| 60 syringe in 1 box, unit-dose / 2.5 mL in 1 syringe | 17856-0691-8 | Atlantic Biologicals | 17 April 2024 |
| 40 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 50268-647-14 | AvPAK | 20 September 2023 |
| 1 bottle, plastic in 1 carton / 50 mL in 1 bottle, plastic | 16714-671-02 | NorthStar Rx | 28 November 2007 |
| 1 bottle, plastic in 1 carton / 50 mL in 1 bottle, plastic | 68071-3611-5 | NuCare Pharmaceuticals,Inc | 19 June 2024 |
| 3 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 68094-763-62 | Precision Dose | 27 February 2015 |
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/5 mL oral solution 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.