"82009-012-10" National Drug Code (NDC)

Simvastatin 1000 TABLET, FILM COATED in 1 BOTTLE (82009-012-10)
(Quallent Pharmaceuticals Health LLC)

NDC Code82009-012-10
Package Description1000 TABLET, FILM COATED in 1 BOTTLE (82009-012-10)
Product NDC82009-012
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSimvastatin
Non-Proprietary NameSimvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20220526
Marketing Category NameANDA
Application NumberANDA200895
ManufacturerQuallent Pharmaceuticals Health LLC
Substance NameSIMVASTATIN
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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