Drug
Who makes dapagliflozin and metformin hydrochloride?
9 companies list dapagliflozin and metformin hydrochloride as a human prescription drug, including under the names XIGDUO XR. Forms: tablet, extended release; 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 dapagliflozin and metformin hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| AstraZeneca PLCUnited States | tablet, film coated, extended release | NDANDA205649 | 5 | 15 |
| Lupin LimitedIndia | tablet, extended release | ANDAANDA211579 | 4 | 14 |
| Aurobindo Pharma LimitedIndia | tablet, film coated, extended release | ANDAANDA211489 | 4 | 6 |
| Macleods Pharmaceuticals LimitedIndia | tablet, extended release | ANDAANDA211559 | 4 | 5 |
| ASCEND Therapeutics US, LLC | tablet, film coated, extended release | ANDAANDA211563 | 4 | 0 |
| Novadoz Pharmaceuticals LLC | tablet, film coated, extended release | ANDAANDA211479 | 4 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated, extended release | ANDAANDA211491 | 3 | 13 |
| Golden State Medical Supply Inc.United States | tablet, film coated, extended release | ANDAANDA211491 | 3 | 1 |
| Prasco Laboratories | tablet, film coated, extended release | NDA AUTHORIZED GENERICNDA205649 | 2 | 0 |
Enquiry
Common questions
- Who makes dapagliflozin and metformin hydrochloride?
- 9 companies list dapagliflozin and metformin hydrochloride as a human prescription drug in the openFDA NDC Directory, led by AstraZeneca PLC, Lupin Limited, Aurobindo Pharma Limited, Macleods Pharmaceuticals Limited, ASCEND Therapeutics US, LLC. 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 XIGDUO XR?
- 7 companies list dapagliflozin and metformin hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.