Data / Drug companies / Dapagliflozin and metformin hydrochloride
Dapagliflozin and metformin hydrochloride: 10 companies and 37 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Dapagliflozin and metformin hydrochloride is listed in the FDA National Drug Code Directory by 10 companies, with 37 products in commercial distribution. 30 of the products (81.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated, extended release; tablet, extended release, and the newest product started marketing on October 1, 2026.
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- Companies listing it
- 10
- Products
- 37
- Generic (ANDA) products
- 30 (81.1%)
- Application numbers
- 8
- Routes
- Oral
- Brand names
- Xigduo XR
- openFDA record search
- api.fda.gov
Companies that list dapagliflozin and metformin hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| AstraZeneca Pharmaceuticals LP | 5 | tablet, film coated, extended release | New drug applications (NDA) | October 29, 2014 |
| Ascend Laboratories, LLC | 4 | tablet, film coated, extended release | Generic drugs (ANDA) | April 6, 2026 |
| Aurobindo Pharma Limited | 4 | tablet, film coated, extended release | Generic drugs (ANDA) | April 6, 2026 |
| Lupin Pharmaceuticals, Inc. | 4 | tablet, extended release | Generic drugs (ANDA) | April 17, 2026 |
| Macleods Pharmaceuticals Limited | 4 | tablet, extended release | Generic drugs (ANDA) | April 6, 2026 |
| Micro Labs Limited | 4 | tablet, film coated, extended release | Generic drugs (ANDA) | October 1, 2026 |
| Novadoz Pharmaceuticals LLC | 4 | tablet, film coated, extended release | Generic drugs (ANDA) | April 6, 2026 |
| Golden State Medical Supply, Inc. | 3 | tablet, film coated, extended release | Generic drugs (ANDA) | March 16, 2026 |
| Sun Pharmaceutical Industries, Inc. | 3 | tablet, film coated, extended release | Generic drugs (ANDA) | April 6, 2026 |
| Prasco Laboratories | 2 | tablet, film coated, extended release | Authorized generics (NDA) | January 3, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated, extended release | 29 | 78.4% |
| Tablet, extended release | 8 | 21.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 30 | 81.1% |
| New drug applications (NDA) | 5 | 13.5% |
| Authorized generics (NDA) | 2 | 5.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Biguanide | 37 |
| Sodium-Glucose Cotransporter 2 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.