"82009-016-05" National Drug Code (NDC)

Simvastatin 500 TABLET, FILM COATED in 1 BOTTLE (82009-016-05)
(Quallent Pharmaceuticals Health LLC)

NDC Code82009-016-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (82009-016-05)
Product NDC82009-016
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
Strength80
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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