Drug
Who makes sitagliptin and metformin hydrochloride?
8 companies list sitagliptin and metformin hydrochloride as a human prescription drug, including under the names JANUMET, JANUMET XR, ZITUVIMET, ZITUVIMET XR. Forms: tablet, film coated; tablet, film coated, extended release. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing sitagliptin and metformin hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Zydus Lifesciences LimitedIndia | tablet, film coated; tablet, film coated, extended release | NDA, NDA AUTHORIZED GENERICNDA216743, NDA216778 | 10 | 12 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated; tablet, film coated, extended release | NDA, NDA AUTHORIZED GENERICNDA216743, NDA216778 | 10 | 1 |
| Merck Sharp & Dohme Corp. | tablet, film coated; tablet, film coated, extended release | NDANDA022044, NDA202270 | 5 | 0 |
| Par Health USA, LLCIndia | tablet, film coated, extended release | ANDAANDA204144 | 3 | 5 |
| International Medication Systems, Ltd.United States | tablet, film coated; tablet, film coated, extended release | NDANDA022044, NDA202270 | 3 | 3 |
| Apotex Inc.Canada | tablet, film coated | ANDAANDA202426 | 2 | 6 |
| Sandoz Industrial Products S.AAustria | tablet, film coated | ANDAANDA202388 | 2 | 5 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA202426 | 2 | 1 |
Enquiry
Common questions
- Who makes sitagliptin and metformin hydrochloride?
- 8 companies list sitagliptin and metformin hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., Merck Sharp & Dohme Corp., Par Health USA, LLC, International Medication Systems, Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic JANUMET?
- 4 companies list sitagliptin and metformin hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.