"68382-065-05" National Drug Code (NDC)

Simvastatin 500 TABLET, FILM COATED in 1 BOTTLE (68382-065-05)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-065-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (68382-065-05)
Product NDC68382-065
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20061220
Marketing Category NameANDA
Application NumberANDA077837
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameSIMVASTATIN
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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