"76519-1004-3" National Drug Code (NDC)

Simvastatin 30 TABLET, FILM COATED in 1 BOTTLE (76519-1004-3)
(H.J. Harkins Company, Inc.)

NDC Code76519-1004-3
Package Description30 TABLET, FILM COATED in 1 BOTTLE (76519-1004-3)
Product NDC76519-1004
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20070816
Marketing Category NameANDA
Application NumberANDA078425
ManufacturerH.J. Harkins Company, Inc.
Substance NameSIMVASTATIN
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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