"0378-4012-05" National Drug Code (NDC)

Glimepiride 500 TABLET in 1 BOTTLE, PLASTIC (0378-4012-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-4012-05
Package Description500 TABLET in 1 BOTTLE, PLASTIC (0378-4012-05)
Product NDC0378-4012
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameGlimepiride
Non-Proprietary NameGlimepiride
Dosage FormTABLET
UsageORAL
Start Marketing Date20060301
Marketing Category NameANDA
Application NumberANDA077624
ManufacturerMylan Pharmaceuticals Inc.
Substance NameGLIMEPIRIDE
Strength2
Strength Unitmg/1
Pharmacy ClassesSulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]

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