Data / Drug companies / Gemcitabine hydrochloride
Gemcitabine hydrochloride: 6 companies and 15 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Gemcitabine hydrochloride is listed in the FDA National Drug Code Directory by 6 companies, with 15 products in commercial distribution. 15 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; injection, solution, and the newest product started marketing on August 8, 2024.
The request: Get every company that lists gemcitabine hydrochloride in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.
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- Companies listing it
- 6
- Products
- 15
- Generic (ANDA) products
- 15 (100.0%)
- Application numbers
- 6
- Routes
- Intravenous
- Brand names
- Gemcitabine, Gemcitabine, Gemcitabine
- openFDA record search
- api.fda.gov
Companies that list gemcitabine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Meitheal Pharmaceuticals Inc. | 4 | injection, solution; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 11, 2020 |
| Mylan Institutional LLC | 3 | injection, solution | Generic drugs (ANDA) | January 3, 2018 |
| Gland Pharma Limited | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | February 1, 2016 |
| NorthStar Rx LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 1, 2018 |
| Sagent Pharmaceuticals | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 29, 2014 |
| Teyro Labs Private Limited | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | August 8, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, powder, lyophilized, for solution | 10 | 66.7% |
| Injection, solution | 5 | 33.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 15 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nucleoside Metabolic Inhibitor | 15 |
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.