Data / Drug companies / Gemcitabine
Gemcitabine: 6 companies and 22 products in the FDA NDC directory
Gemcitabine is listed in the FDA National Drug Code Directory by 6 companies, with 22 products in commercial distribution. 14 of the products (63.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection, powder, lyophilized, for solution, and the newest product started marketing on October 17, 2025.
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- Companies listing it
- 6
- Products
- 22
- Generic (ANDA) products
- 14 (63.6%)
- Application numbers
- 8
- Routes
- Intravenous
- Brand names
- Avgemsi
- openFDA record search
- api.fda.gov
Companies that list gemcitabine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hospira, Inc. | 9 | injection, solution; injection, powder, lyophilized, for solution | New drug applications (NDA) | July 29, 2013 |
| Fresenius Kabi USA, LLC | 5 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 26, 2011 |
| Hikma Pharmaceuticals USA Inc. | 3 | injection, solution | Generic drugs (ANDA) | October 17, 2025 |
| Avyxa Pharma, LLC | 2 | injection, solution | New drug applications (NDA) | August 3, 2025 |
| Dr. Reddy's Laboratories Limited | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 25, 2011 |
| Sagent Pharmaceuticals | 1 | injection, solution | Generic drugs (ANDA) | January 15, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 12 | 54.5% |
| Injection, powder, lyophilized, for solution | 10 | 45.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 14 | 63.6% |
| New drug applications (NDA) | 8 | 36.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nucleoside Metabolic Inhibitor | 22 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.