"70661-003-10" National Drug Code (NDC)

Roszet 10 TABLET in 1 BOTTLE (70661-003-10)
(Althera Pharmaceuticals LLC)

NDC Code70661-003-10
Package Description10 TABLET in 1 BOTTLE (70661-003-10)
Product NDC70661-003
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRoszet
Non-Proprietary Name(rosuvastatin And Ezetimibe)
Dosage FormTABLET
UsageORAL
Start Marketing Date20210510
Marketing Category NameNDA
Application NumberNDA213072
ManufacturerAlthera Pharmaceuticals LLC
Substance NameEZETIMIBE; ROSUVASTATIN CALCIUM
Strength10; 20.8
Strength Unitmg/1; mg/1
Pharmacy ClassesDecreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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