NDC Code | 0006-0078-28 |
Package Description | 2 BOTTLE in 1 CARTON (0006-0078-28) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-14) |
Product NDC | 0006-0078 |
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 | Merck Sharp & Dohme LLC |
Substance Name | METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
Strength | 500; 50 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA] |