"53002-1569-0" National Drug Code (NDC)

Simvastatin 100 TABLET, FILM COATED in 1 BOTTLE (53002-1569-0)
(RPK Pharmaceuticals, Inc.)

NDC Code53002-1569-0
Package Description100 TABLET, FILM COATED in 1 BOTTLE (53002-1569-0)
Product NDC53002-1569
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20080226
Marketing Category NameANDA
Application NumberANDA078155
ManufacturerRPK Pharmaceuticals, Inc.
Substance NameSIMVASTATIN
Strength40
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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