"0378-5405-05" National Drug Code (NDC)

Simvastatin 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5405-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5405-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5405-05)
Product NDC0378-5405
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20120323
Marketing Category NameANDA
Application NumberANDA090868
ManufacturerMylan Pharmaceuticals Inc.
Substance NameSIMVASTATIN
Strength80
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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