"57297-482-03" National Drug Code (NDC)

Simvastatin 1000 TABLET, FILM COATED in 1 BOTTLE (57297-482-03)
(LUPIN LIMITED)

NDC Code57297-482-03
Package Description1000 TABLET, FILM COATED in 1 BOTTLE (57297-482-03)
Product NDC57297-482
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20090714
Marketing Category NameANDA
Application NumberANDA078103
ManufacturerLUPIN LIMITED
Substance NameSIMVASTATIN
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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