| NDC Code | 50090-4411-0 |
| Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4411-0) |
| Product NDC | 50090-4411 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Janumet |
| Proprietary Name Suffix | Xr |
| Non-Proprietary Name | Sitagliptin And Metformin Hydrochloride |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20120202 |
| Marketing Category Name | NDA |
| Application Number | NDA202270 |
| Manufacturer | A-S Medication Solutions |
| Substance Name | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
| Strength | 1000; 50 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA] |