Prescription medicine
Vinorelbine First approved as Navelbine
Vinorelbine (Navelbine) is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the vinorelbine FDA label on DailyMed (effective August 16, 2024, Sagent Pharmaceuticals); the NDA 20388 record on Drugs@FDA; every vinorelbine label on DailyMed.
Highlights of the record
FDA label of August 16, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
MYELOSUPPRESSION.
Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions ( 5.1 )]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration ( 2.2 )]. WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Severe myelosuppression resulting in serious infection, septic shock, and death can occur ( 5.1 ). Decrease the dose or withhold vinorelbine in accord with recommended dose modifications ( 2.2 ).
Used for
From the label: indications and usageVinorelbine 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: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung
Forms and strengths
- 10 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- December 23, 1994 Navelbine, Pierre Fabre; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first February 3, 2003; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,869 through July 30, 2026
What is vinorelbine used for?
From the label: indications and usageVinorelbine 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: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ( 1 ) As a single agent for first-line treatment of patients with metastatic NSCLC
Conditions named in the indications of vinorelbine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Vinca Alkaloid.
Source: FDA drug label (Vinorelbine), Sagent Pharmaceuticals, effective August 16, 2024 (SPL set 10a70995-e04d-4044-b1dc-c9aa27460397), via openFDA; the full label on DailyMed
Is there a generic for vinorelbine (Navelbine)?
The FDA approved the first generic vinorelbine on February 3, 2003. 11 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists vinorelbine from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1994 earliest approval on file
- 2003 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vinorelbine label say about other medicines?
The vinorelbine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name vinorelbine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cisplatin | warnings and precautions | Myelosuppression Myelosuppression, manifested by neutropenia, anemia and thrombocytopenia, occur in patients receiving vinorelbine as a single agent and in combination with cisplatin [see Adverse Reactions ( 6.1 , 6.2 )]. Neutropenia is the major dose-limiting toxicity with vinorelbine. |
Source: FDA drug label (Vinorelbine), Sagent Pharmaceuticals, effective August 16, 2024 (SPL set 10a70995-e04d-4044-b1dc-c9aa27460397), via openFDA; the full label on DailyMed
What do FAERS reports show for vinorelbine?
The FDA Adverse Event Reporting System holds 6,869 reports that list vinorelbine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,452 are coded as a death and 2,181 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as vinorelbine?
16 other medicines are given the same way (intravenous) and in the same FDA class as vinorelbine or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Pemetrexed | Lung cancer | 15 labelers | n/a | A presentation being discontinued |
| Etoposide | Lung cancer | 5 labelers | n/a | No current entry |
| Topotecan | Lung cancer | 4 labelers | n/a | No current entry |
| Nivolumab | Lung cancer | none listed | n/a | No current entry |
| Atezolizumab | Lung cancer | none listed | n/a | No current entry |
| Durvalumab | Lung cancer | none listed | n/a | No current entry |
| Ipilimumab | Lung cancer | none listed | n/a | No current entry |
| Ramucirumab | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as vinorelbine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to vinorelbine
- 16 medicines for the same use
- Other vinca alkaloids
- the pharmacologic class, with prices and generics
- Vinorelbine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other