"0597-0168-18" National Drug Code (NDC)

Synjardy 180 TABLET in 1 BOTTLE (0597-0168-18)
(Boehringer Ingelheim Pharmaceuticals, Inc.)

NDC Code0597-0168-18
Package Description180 TABLET in 1 BOTTLE (0597-0168-18)
Product NDC0597-0168
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSynjardy
Non-Proprietary NameEmpagliflozin And Metformin Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20150826
Marketing Category NameNDA
Application NumberNDA206111
ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Strength12.5; 1000
Strength Unitmg/1; mg/1
Pharmacy ClassesBiguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]

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