Medicine
Etoposide 100 mg/5 mL injection
Etoposide 100 mg/5 mL injection is a generic prescription medicine for intravenous use, made by 5 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). See USP controlled room temperature.
Key facts
- Active ingredient (INN)
- Etoposide
- Brand
- Sold under the generic name
- Strength
- 100 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 5 mL, 10 boxes of 5 mL and 5 more
- Manufacturers
- Accord HealthcareIndiaBluePoint LaboratoriesFresenius KabiHikma PharmaceuticalsMeitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01CB01 Etoposide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 1996
- Identifiers
- RxCUI 310248DailyMed set ID e0cd61b9-2375-4e3d-a610-d87dad962468, 157d4e0f-806d-4011-9dec-97e2449e507b, 0dddbe44-b4f4-431f-9011-8a54abbd4cbf +3NDC 0143-9376, 68001-265, 68001-681 +4Application ANDA074290, ANDA074513, ANDA074529 +1
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, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 16729-114-31 | Accord HealthcareIndia | 22 March 2015 |
| 1 vial in 1 box, unit-dose / 5 mL in 1 vial | 0143-9376-01 | Hikma Pharmaceuticals | 1 October 2019 |
| 1 vial in 1 box, unit-dose / 5 mL in 1 vial | 0143-9510-01 | Hikma Pharmaceuticals | 23 October 2017 |
| 10 box in 1 carton / 1 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 63323-104-05 | Fresenius Kabi | 18 July 2001 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 63323-104-06 | Fresenius Kabi | 9 September 2022 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 71288-175-05 | Meitheal Pharmaceuticals | 1 February 2025 |
| 1 vial, multi-dose in 1 box / 5 mL in 1 vial, multi-dose | 68001-265-25 | BluePoint Laboratories | 14 November 2013 |
| 1 vial, multi-dose in 1 carton / 5 mL in 1 vial, multi-dose | 68001-681-25 | BluePoint Laboratories | 1 December 2025 |
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 10 November 1983 | 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
Alternatives
Other makers and brands of Etoposide 100 mg/5 mL injection.
Other strengths and forms of Etoposide
Clinical summary
Etoposide is a topoisomerase inhibitor indicated in the management of small Cell Lung Cancer —Etoposide capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer. MedsAcross supplies Etoposide 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 EtoposideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VePesid prescribing information (Onesource Specialty Pharma) · U.S. National Library of Medicine, DailyMed
Need Etoposide 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.