Data / Drug companies / Sitagliptin and metformin hydrochloride
Sitagliptin and metformin hydrochloride: 8 companies and 37 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Sitagliptin and metformin hydrochloride is listed in the FDA National Drug Code Directory by 8 companies, with 37 products in commercial distribution. 9 of the products (24.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated, extended release; tablet, film coated, and the newest product started marketing on July 24, 2026.
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- Companies listing it
- 8
- Products
- 37
- Generic (ANDA) products
- 9 (24.3%)
- Application numbers
- 7
- Routes
- Oral
- Brand names
- Zituvimet XR, Janumet, Janumet XR, Zituvimet
- openFDA record search
- api.fda.gov
Companies that list sitagliptin and metformin hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Zydus Lifesciences Limited | 10 | tablet, film coated, extended release; tablet, film coated | New drug applications (NDA) | October 31, 2024 |
| Zydus Pharmaceuticals USA Inc. | 10 | tablet, film coated, extended release; tablet, film coated | New drug applications (NDA) | October 31, 2024 |
| Merck Sharp & Dohme LLC | 5 | tablet, film coated, extended release; tablet, film coated | New drug applications (NDA) | February 2, 2012 |
| A-S Medication Solutions | 3 | tablet, film coated; tablet, film coated, extended release | New drug applications (NDA) | February 2, 2012 |
| Par Health USA, LLC | 3 | tablet, film coated, extended release | Generic drugs (ANDA) | July 24, 2026 |
| Apotex Corp. | 2 | tablet, film coated | Generic drugs (ANDA) | May 28, 2026 |
| Golden State Medical Supply, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | April 30, 2026 |
| Sandoz Inc | 2 | tablet, film coated | Generic drugs (ANDA) | May 28, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated, extended release | 19 | 51.4% |
| Tablet, film coated | 18 | 48.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 18 | 48.6% |
| Authorized generics (NDA) | 10 | 27% |
| Generic drugs (ANDA) | 9 | 24.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Biguanide | 37 |
| Dipeptidyl Peptidase 4 Inhibitor | 37 |
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.