Medicine
Irinotecan 100 mg/5 mL injection
Irinotecan 100 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 11 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
Protect from freezing. Store at 20° to 25° C (68° to 77° F). See USP…
Key facts
- Active ingredient (INN)
- Irinotecan
- Brand
- Sold under the generic name
- Strength
- 100 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL, 5 mL and 10 more
- Manufacturers
- EugiaIndiaGland PharmaIndiaApotexHikma PharmaceuticalsActavis PharmaBluePoint LaboratoriesFresenius KabiHospiraNorthStar RxQilu Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20° to 25° C (68° to 77° F). See USP Controlled Room Temperature (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
- L01CE02 Irinotecan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 February 2008
- Identifiers
- RxCUI 1726324, 1726319, 1726492 +1DailyMed set ID 9c6aa884-750e-4b11-9955-bc7ab6e9c2ad, be716692-6b4f-47b6-83d1-01665861626b, 85ed6019-f462-4abe-a89e-ad991623c86d +10NDC 0143-9583, 0143-9701, 60505-6128 +10Application ANDA091032, ANDA203380, ANDA212993 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 55150-353-01 | EugiaIndia | 11 February 2020 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 68083-382-01 | Gland PharmaIndia | 18 November 2019 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 60505-6128-1 | Apotex | 30 November 2017 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 60505-6272-1 | Apotex | 1 July 2023 |
| 5 mL in 1 vial, glass | 0143-9583-01 | Hikma Pharmaceuticals | 20 December 2010 |
| 5 mL in 1 vial, glass | 0143-9701-01 | Hikma Pharmaceuticals | 20 December 2010 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 45963-614-55 | Actavis Pharma | 12 March 2015 |
| 1 vial in 1 box / 5 mL in 1 vial | 63323-193-55 | Fresenius Kabi | 1 April 2009 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 61703-349-09 | Hospira | 27 February 2008 |
| 1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use | 67184-0512-1 | Qilu Pharmaceutical | 3 May 2016 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 70700-170-22 | Xiromed | 18 November 2019 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 68001-480-22 | BluePoint Laboratories | 14 December 2020 |
| 1 vial, single-dose in 1 carton / 5 mL in 1 vial, single-dose | 16714-131-01 | Northstar Rx | 15 November 2020 |
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 Irinotecan 100 mg/5 mL injection.
Other strengths and forms of Irinotecan
Clinical summary
Irinotecan is a topoisomerase inhibitor indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum, among other approved uses. MedsAcross supplies Irinotecan 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 IrinotecanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Camptosar prescribing information (Pharmacia & Upjohn) · U.S. National Library of Medicine, DailyMed
- Onivyde pegylated liposomal (previously Onivyde): European public assessment report (EPAR) · European Medicines Agency
Need Irinotecan 100 mg/5 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.