"53217-204-60" National Drug Code (NDC)

Simvastatin 60 TABLET, FILM COATED in 1 BOTTLE (53217-204-60)
(Aidarex Pharmaceuticals LLC)

NDC Code53217-204-60
Package Description60 TABLET, FILM COATED in 1 BOTTLE (53217-204-60)
Product NDC53217-204
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20130902
Marketing Category NameANDA
Application NumberANDA078155
ManufacturerAidarex Pharmaceuticals LLC
Substance NameSIMVASTATIN
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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