Medicine
Ondansetron 4 mg/2 mL injection
Ondansetron 4 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 21 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.
Key facts
- Active ingredient (INN)
- Ondansetron
- Brand
- Sold under the generic name
- Strength
- 4 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 10 vials of 2 mL, 25 vials of 2 mL, 5 vials of 2 mL and 36 more
- Manufacturers
- Avet PharmaceuticalsIndiaEugiaIndiaGland PharmaIndiaCardinal HealthFresenius KabiHealthFirstHospiraMedical Purchasing SolutionsApotexHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°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 283504, 1740467, 1314133DailyMed set ID e3f22b7e-b6ad-4799-93c7-d30540cada85, 70437694-0341-4f3b-824c-06843403443f, 768aa02b-8231-5799-e053-2a91aa0a618d +32NDC 72266-123, 72572-520, 51662-1245 +33Application ANDA079224, ANDA077541, ANDA202600 +7
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 |
|---|---|---|---|
| 10 vial in 1 carton / 2 mL in 1 vial | 23155-547-41 | Avet PharmaceuticalsIndia | 15 June 2012 |
| 25 vial in 1 carton / 2 mL in 1 vial | 23155-547-42 | Avet PharmaceuticalsIndia | 15 June 2012 |
| 10 vial in 1 carton / 2 mL in 1 vial | 23155-548-41 | Avet PharmaceuticalsIndia | 9 November 2015 |
| 25 vial in 1 carton / 2 mL in 1 vial | 23155-548-42 | Avet PharmaceuticalsIndia | 9 November 2015 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 55150-125-02 | EugiaIndia | 21 December 2012 |
| 5 vial in 1 carton / 2 mL in 1 vial | 68083-113-01 | Gland PharmaIndia | 25 September 2009 |
| 25 vial in 1 tray / 2 mL in 1 vial | 63323-373-02 | Fresenius Kabi | 18 November 2009 |
| 25 vial in 1 tray / 2 mL in 1 vial | 65219-323-02 | Fresenius Kabi | 22 January 2024 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 2 mL in 1 syringe, glass | 76045-103-20 | Fresenius Kabi | 10 December 2015 |
| 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 2 mL in 1 syringe, glass | 76045-216-20 | Fresenius Kabi | 31 May 2022 |
| 25 vial, single-dose in 1 tray / 2 mL in 1 vial, single-dose | 0409-0009-25 | Hospira | 16 December 2024 |
| 25 vial, single-dose in 1 tray / 2 mL in 1 vial, single-dose | 0409-2271-25 | Hospira | 1 December 2025 |
| 25 vial, single-dose in 1 tray / 2 mL in 1 vial, single-dose | 0409-4755-03 | Hospira | 16 October 2008 |
| 25 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 60505-4939-2 | Apotex | 29 September 2026 |
| 25 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 60505-6130-5 | Apotex | 26 May 2016 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0641-6078-25 | Hikma Pharmaceuticals | 26 December 2006 |
| 25 vial in 1 carton / 2 mL in 1 vial | 0641-6080-25 | Hikma Pharmaceuticals | 26 December 2006 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 36000-012-25 | Baxter Healthcare | 13 March 2013 |
| 25 vial in 1 carton / 2 mL in 1 vial | 72266-123-25 | Fosun Pharma | 2 April 2019 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 83270-160-03 | Onesource Specialty Pharma | 30 September 2023 |
| 5 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 67184-0507-5 | Qilu Pharmaceutical | 8 September 2014 |
| 25 vial in 1 carton / 2 mL in 1 vial | 25021-777-02 | Sagent Pharmaceuticals | 30 August 2012 |
| 25 vial, single-dose in 1 carton / 2 mL in 1 vial, single-dose | 0143-9891-25 | West-Ward Pharmaceuticals | 26 December 2006 |
| 5 vial in 1 bag / 2 mL in 1 vial | 55154-2876-5 | Cardinal Health | 26 December 2006 |
| 5 vial in 1 bag / 2 mL in 1 vial | 55154-2877-5 | Cardinal Health | 26 December 2006 |
| 5 vial in 1 bag / 2 mL in 1 vial | 55154-4453-5 | Cardinal Health | 13 March 2013 |
| 5 vial, single-dose in 1 bag / 2 mL in 1 vial, single-dose | 55154-6976-5 | Cardinal Health | 16 October 2008 |
| 2 mL in 1 vial, single-dose | 51662-1245-1 | HealthFirst | 23 September 2018 |
| 25 pouch in 1 case / 1 vial in 1 pouch / 2 mL in 1 vial | 51662-1245-3 | HealthFirst | 23 September 2018 |
| 2 mL in 1 vial | 51662-1366-1 | HealthFirst | 8 December 2019 |
| 2 mL in 1 vial, single-dose | 51662-1469-1 | HealthFirst | 14 December 2019 |
| 1 vial, single-use in 1 bag / 2 mL in 1 vial, single-use | 71872-7068-1 | Medical Purchasing Solutions | 5 March 2018 |
| 1 vial in 1 bag / 2 mL in 1 vial | 71872-7140-1 | Medical Purchasing Solutions | 5 June 2018 |
| 1 vial, single-dose in 1 bag / 2 mL in 1 vial, single-dose | 71872-7162-1 | Medical Purchasing Solutions | 23 April 2019 |
| 25 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 50090-4935-0 | A-S Medication Solutions | 27 February 2020 |
| 25 vial in 1 carton / 2 mL in 1 vial | 72572-520-25 | Civica | 18 November 2019 |
| 1 vial, single-use in 1 bag / 2 mL in 1 vial, single-use | 0404-9930-02 | Henry Schein | 13 January 2022 |
| 2 mL in 1 vial, single-use | 84549-130-05 | ProPharma Distribution | 1 September 2025 |
| 25 vial, single-use in 1 carton / 2 mL in 1 vial, single-use | 85766-234-25 | Sportpharm | 2 July 2026 |
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/2 mL injection 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.