Medicine
Irinotecan 300 mg/15 mL injection
Irinotecan 300 mg/15 mL injection is a generic prescription medicine for intravenous use, made by 2 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). Protect from light.
Key facts
- Active ingredient (INN)
- Irinotecan
- Brand
- Sold under the generic name
- Strength
- 300 mg/15 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 15 mL
- Manufacturers
- EugiaIndiaQilu Pharmaceutical
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 3 May 2016
- Identifiers
- RxCUI 1726319, 1726324, 1726333DailyMed set ID 7a30d551-9ea7-47ea-9073-f541bff457a3, afcdde49-ec0c-4c56-a1af-2917185b1a08NDC 55150-354, 67184-0513Application ANDA213278, ANDA203380
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 / 15 mL in 1 vial, single-dose | 55150-354-01 | EugiaIndia | 11 February 2020 |
| 1 vial, single-use in 1 carton / 15 mL in 1 vial, single-use | 67184-0513-1 | Qilu Pharmaceutical | 3 May 2016 |
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 300 mg/15 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 300 mg/15 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.