Quick answers
- What is Vinorelbine used for?
- The FDA-approved label (Vinorelbine, Sagent Pharmaceuticals, August 16, 2024) says: “Vinorelbine Injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine Injection is a vinca alkaloid indicated …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Vinorelbine have a boxed warning?
- Yes. The FDA label for Vinorelbine has a boxed warning (“WARNING: MYELOSUPPRESSION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Vinorelbine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Vinorelbine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Vinorelbine?
- 2 companies list prescription products of Vinorelbine in the FDA NDC Directory, including Sagent Pharmaceuticals and Actavis Pharma, Inc..
What Vinorelbine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Vinorelbine Injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine Injection is a vinca alkaloid indicated …
— FDA label: Vinorelbine, Sagent Pharmaceuticals, effective August 16, 2024. Read the full label on DailyMed →
The FDA has 2 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.
This label has a boxed warning. Its heading: WARNING: MYELOSUPPRESSION
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
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.
- Sagent Pharmaceuticals1 product
- Actavis Pharma, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA078011Actavis Totowa · July 22, 2009
- ANDA091106Jiangsu Hansoh Pharm · September 26, 2012
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) | 1729418, 1729422 |
|---|---|
| SPL set ID of the quoted label | 10a70995-e04d-4044-b1dc-c9aa27460397 |
| FDA labels (SPL) | 2 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | VINORELBINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vinorelbine, Sagent Pharmaceuticals, effective August 16, 2024; 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 →