Prescription medicine
Gemcitabine Brand names: Avgemsi, Inlexzo; first approved as Gemzar
Gemcitabine (Gemzar) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 10 generic labelers.
- Generic listed
Check it at the source: the gemcitabine FDA label on DailyMed (effective October 14, 2024, Fresenius Kabi USA, LLC); the NDA 20509 record on Drugs@FDA; every gemcitabine label on DailyMed.
Highlights of the record
FDA label of October 14, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGemcitabine for Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
Forms and strengths
- 1 g
- 200 mg
- 225 mg
- 1 g/25ml
- 1 g/26.3ml
- 2 g/50ml
- 2 g/52.6ml
- 38 mg/ml
- 100 mg/ml
- 200 mg/5ml
- 200 mg/5.26ml
Injection (solution); injection (powder) (lyophilized) for solution; system.
On the market
- Earliest approval on file
- May 15, 1996 Gemzar, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 28 first November 15, 2010; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 10 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- November 7, 2038 Inlexzo system; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2014 3 Class I among all firms' recalls; latest June 10, 2026; 3 more by firms not listed as its makers
- FAERS reports
- 53,011 through July 30, 2026
What is gemcitabine used for?
From the label: indications and usageGemcitabine for Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. ( 1.1 ) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic cancer. […]
Conditions named in the indications of gemcitabine's FDA labels, with every medicine labeled for each:
From other gemcitabine labelsLung cancer: … contraindicated. ( 1.2 ) in combination with cisplatin, for the treatment of non-small cell lung cancer. ( 1.3 ) as a single agent for the treatment of pancreatic […]
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (GEMCITABINE), Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set c550dd16-a5e8-44be-87f2-210c15bbb513), via openFDA; the full label on DailyMed
What does the patient leaflet for gemcitabine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid after INLEXZO is inserted?Tell your healthcare provider that you have INLEXZO before having a type of scan called Magnetic Resonance Imaging (MRI). INLEXZO may be used under specific conditions. Your healthcare provider will give you an MRI Safety Information Card. Keep the card in a safe place and show it to all of your healthcare providers. The card contains important information in case you need to have an MRI. Your healthcare provider will review the information on the MRI Safety Information Card and determine the conditions they can safely do an MRI scan while INLEXZO is in your bladder.
Source: FDA drug label (INLEXZO), Janssen Biotech, Inc, effective September 11, 2025 (SPL set 3aef8dbc-34d0-4150-89f0-3b16cf0fbfdb), via openFDA; the full label on DailyMed
Is there a generic for gemcitabine (Gemzar)?
The FDA approved the first generic gemcitabine on November 15, 2010. 28 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists gemcitabine from 10 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Gemzar injection; a patent listed only for Inlexzo system runs to November 7, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2010 first generic approved
- 2038 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has gemcitabine been recalled?
The FDA's Enforcement Report lists 8 recalls naming gemcitabine since 2014: 3 Class I (the most serious), 5 Class II, 0 Class III; 1 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of gemcitabine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 10, 2026 | Class II | McKesson | Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility |
| March 15, 2021 | Class II | Cardinal Health Inc. not a listed maker | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
| March 23, 2015 | Class I | Mylan Institutional LLC | Presence of Particulate Matter |
| April 9, 2014 | Class II | Caraco Pharmaceutical Laboratories, Ltd. not a listed maker | Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the gemcitabine label say about other medicines?
The gemcitabine label names no other medicine on this site. The labels of 6 other medicines name gemcitabine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name gemcitabine
Source: FDA drug label (GEMCITABINE), Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set c550dd16-a5e8-44be-87f2-210c15bbb513), via openFDA; the full label on DailyMed
What do FAERS reports show for gemcitabine?
The FDA Adverse Event Reporting System holds 53,011 reports that list gemcitabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,971 are coded as a death and 21,055 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 gemcitabine?
14 other medicines are given the same way (intravenous) and in the same FDA class as gemcitabine or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 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 |
|---|---|---|---|---|
| Docetaxel | Breast cancer, Lung cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer, Lung cancer | 20 labelers | n/a | No current entry |
| Eribulin | Breast cancer | 14 labelers | n/a | No current entry |
| Trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
| Datopotamab deruxtecan | Breast cancer, Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as gemcitabine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does gemcitabine compare with medicines for the same use?
1 side-by-side page set gemcitabine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to gemcitabine
- 14 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Gemcitabine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other