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] |