| NDC Code | 0310-6125-92 |
| Package Description | 1 BLISTER PACK in 1 CARTON (0310-6125-92) > 12 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 0310-6125 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Kombiglyze |
| Proprietary Name Suffix | Xr |
| Non-Proprietary Name | Saxagliptin And Metformin Hydrochloride |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20141204 |
| Marketing Category Name | NDA |
| Application Number | NDA200678 |
| Manufacturer | AstraZeneca Pharmaceuticals LP |
| Substance Name | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
| Strength | 1000; 2.5 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA] |