"0378-8176-91" National Drug Code (NDC)

Saxagliptin And Metformin 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8176-91)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-8176-91
Package Description60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8176-91)
Product NDC0378-8176
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSaxagliptin And Metformin
Non-Proprietary NameSaxagliptin And Metformin
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20230808
Marketing Category NameANDA
Application NumberANDA205981
ManufacturerMylan Pharmaceuticals Inc.
Substance NameMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
Strength1000; 2.5
Strength Unitmg/1; mg/1
Pharmacy ClassesBiguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]

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