"0378-5121-05" National Drug Code (NDC)

Fluvastatin Sodium 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5121-05)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5121-05
Package Description500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5121-05)
Product NDC0378-5121
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameFluvastatin Sodium
Non-Proprietary NameFluvastatin
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20150911
Marketing Category NameANDA
Application NumberANDA202458
ManufacturerMylan Pharmaceuticals Inc.
Substance NameFLUVASTATIN SODIUM
Strength80
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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