Medicine
Palonosetron 0.25 mg/5 mL injection
Palonosetron 0.25 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 14 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 20º to 25ºC (68º to 77ºF), excursions permitted between 15º to 30 °C…
Key facts
- Active ingredient (INN)
- Palonosetron
- Brand
- Sold under the generic name
- Strength
- 0.25 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL, 10 vials of 5 mL, 10 syringes of 5 mL and 16 more
- Manufacturers
- CiplaIndiaDr. Reddy's LaboratoriesIndiaEugiaIndiaApotexBluePoint LaboratoriesFresenius KabiSandozBaxter HealthcareMeitheal PharmaceuticalsMylan Institutional
- Origin register
- US FDA, United States
- Storage
- Store at 20º to 25ºC (68º to 77ºF), excursions permitted between 15º to 30 °C (59º to 86°F). • Protect from freezing. • Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A04AA05 Palonosetron
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 March 2018
- Identifiers
- RxCUI 1728055, 1728050, 2056929DailyMed set ID 0f3bfe3d-75c8-42eb-84be-570f8e251fdd, 911783eb-91a8-4ef4-bd6f-809211e207d6, 991b8452-852c-c55c-7b1b-e97c4964777a +14NDC 36000-326, 0703-4094, 55111-694 +13Application ANDA206916, ANDA090713, ANDA201533 +9
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 vial in 1 carton / 5 mL in 1 vial | 69097-927-35 | CiplaIndia | 23 March 2018 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 55111-694-07 | Dr. Reddy's LaboratoriesIndia | 23 March 2018 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 55150-186-05 | EugiaIndia | 6 November 2018 |
| 1 vial in 1 carton / 5 mL in 1 vial | 60505-6193-1 | Apotex | 19 September 2018 |
| 10 vial in 1 carton / 5 mL in 1 vial | 60505-6193-4 | Apotex | 19 September 2018 |
| 1 vial in 1 carton / 5 mL in 1 vial | 60505-6439-1 | Apotex | 31 October 2025 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 63323-673-05 | Fresenius Kabi | 19 September 2018 |
| 10 syringe, plastic in 1 carton / 5 mL in 1 syringe, plastic | 63323-673-89 | Fresenius Kabi | 19 September 2018 |
| 1 vial in 1 carton / 5 mL in 1 vial | 36000-326-02 | Baxter Healthcare | 12 November 2021 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 71288-409-05 | Meitheal Pharmaceuticals | 14 August 2023 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 67457-317-25 | Mylan Institutional | 20 September 2018 |
| 1 vial in 1 carton / 5 mL in 1 vial | 67184-0514-1 | Qilu Pharmaceutical | 19 September 2018 |
| 1 vial in 1 carton / 5 mL in 1 vial | 25021-783-05 | Sagent Pharmaceuticals | 15 June 2018 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 0781-3312-75 | Sandoz | 23 March 2018 |
| 10 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 0781-3312-95 | Sandoz | 1 October 2024 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 0703-4094-01 | Teva Parenteral Medicines | 23 March 2018 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 68001-355-25 | BluePoint Laboratories | 30 May 2018 |
| 1 vial in 1 carton / 5 mL in 1 vial | 68001-708-25 | BLuePoint Laboratories | 15 July 2026 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 16714-834-01 | NorthStar Rx | 29 May 2018 |
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.
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
Alternatives
Other makers and brands of Palonosetron 0.25 mg/5 mL injection.
Other strengths and forms of Palonosetron
Clinical summary
Palonosetron is a serotonin-3 receptor antagonist. It is available as injection for intravenous use. MedsAcross supplies Palonosetron 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 PalonosetronFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- palonosetron hydrochloride prescribing information (Cipla) · U.S. National Library of Medicine, DailyMed
- Aloxi: European public assessment report (EPAR) · European Medicines Agency
- Palonosetron Accord: European public assessment report (EPAR) · European Medicines Agency
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