"0115-1648-01" National Drug Code (NDC)

Glyburide And Metformin Hydrochloride 100 TABLET, FILM COATED in 1 BOTTLE (0115-1648-01)
(Impax Generics)

NDC Code0115-1648-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE (0115-1648-01)
Product NDC0115-1648
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGlyburide And Metformin Hydrochloride
Non-Proprietary NameGlyburide And Metformin Hydrochloride
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20160803
Marketing Category NameANDA
Application NumberANDA076716
ManufacturerImpax Generics
Substance NameGLYBURIDE; METFORMIN HYDROCHLORIDE
Strength1.25; 250
Strength Unitmg/1; mg/1
Pharmacy ClassesSulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]

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