"54458-932-16" National Drug Code (NDC)

Simvastatin 30 TABLET, FILM COATED in 1 BOTTLE (54458-932-16)
(International Laboratories, LLC)

NDC Code54458-932-16
Package Description30 TABLET, FILM COATED in 1 BOTTLE (54458-932-16)
Product NDC54458-932
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20101122
Marketing Category NameANDA
Application NumberANDA076052
ManufacturerInternational Laboratories, LLC
Substance NameSIMVASTATIN
Strength40
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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