Quick answers
- What is Etoposide used for?
- The FDA-approved label (Etopophos, H2-Pharma, LLC, July 31, 2026) says: “ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. Small cell lung cancer, in combination with cisplatin, as first-line treatment. 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Etoposide have a boxed warning?
- The label we quote has no boxed warning, but 8 of 9 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Etoposide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Etoposide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Etoposide?
- 10 companies list prescription products of Etoposide in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., BluePoint Laboratories and Meitheal Pharmaceuticals Inc..
What Etoposide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ETOPOPHOS is a topoisomerase inhibitor indicated for the treatment of patients with: Refractory testicular tumors, in combination with other chemotherapeutic drugs. Small cell lung cancer, in combination with cisplatin, as first-line treatment. 1.1 Refractory Testicular Tumors ETOPOPHOS is indicated, in combination with other chemotherapeutic drugs, for treatment of patients with refractory testicular tumors. …
— FDA label: Etopophos, H2-Pharma, LLC, effective July 31, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
8 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.4 products
- BluePoint Laboratories4 products
- Meitheal Pharmaceuticals Inc.3 products
- Avyxa Pharma, LLC2 products
- Amneal Pharmaceuticals LLC1 product
- Fresenius Kabi USA, LLC1 product
- Onesource Specialty Pharma Limited1 product
- Accord Healthcare Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- H2-Pharma, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019557 VEPESID | Onesource Specialty | December 30, 1986 | 18, latest November 5, 2002 2002: Labeling · 2000: Manufacturing (CMC) · 2000: Manufacturing (CMC) |
| NDA020457 ETOPOPHOS PRESERVATIVE FREE | Cheplapharm | May 17, 1996 | 11, latest September 2, 2026 2026: Labeling · 2019: Labeling · 2017: Labeling |
| NDA220200 AVOPEF | Avyxa Holdings | February 13, 2026 | — |
Generic approvals (5)
- ANDA074290Hikma · July 17, 1995
- ANDA074513Accord Hlthcare · March 14, 1996
- ANDA074529Meitheal · July 24, 1996
- ANDA074983Fresenius Kabi USA · September 30, 1998
- ANDA075635Mylan · September 19, 2001
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 197687, 226719, 310248, 1734340 |
|---|---|
| SPL set ID of the quoted label | 7499fc35-fae8-44ad-bbab-9a1a589bf3ee |
| FDA labels (SPL) | 9 |
| FDA applications | NDA019557, NDA020457, NDA220200, 5 ANDA |
| Active ingredients (FDA) | ETOPOSIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Etopophos, H2-Pharma, LLC, effective July 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →