"53401-013-45" National Drug Code (NDC)

Simvastatin 45 TABLET, FILM COATED in 1 BOTTLE (53401-013-45)
(Aphena Pharma Solutions - Tennessee, LLC)

NDC Code53401-013-45
Package Description45 TABLET, FILM COATED in 1 BOTTLE (53401-013-45)
Product NDC53401-013
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20061220
Marketing Category NameANDA
Application NumberANDA078034
ManufacturerAphena Pharma Solutions - Tennessee, LLC
Substance NameSIMVASTATIN
Strength10
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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