"42658-109-08" National Drug Code (NDC)

Simvastatin 1000 TABLET, FILM COATED in 1 BOTTLE (42658-109-08)
(Hisun Pharmaceuticals USA, Inc.)

NDC Code42658-109-08
Package Description1000 TABLET, FILM COATED in 1 BOTTLE (42658-109-08)
Product NDC42658-109
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20200501
Marketing Category NameANDA
Application NumberANDA206557
ManufacturerHisun Pharmaceuticals USA, Inc.
Substance NameSIMVASTATIN
Strength20
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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