"82009-188-05" National Drug Code (NDC)

Rosuvastatin 500 TABLET, FILM COATED in 1 BOTTLE (82009-188-05)
(Quallent Pharmaceuticals Health LLC)

NDC Code82009-188-05
Package Description500 TABLET, FILM COATED in 1 BOTTLE (82009-188-05)
Product NDC82009-188
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRosuvastatin
Non-Proprietary NameRosuvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20251215
Marketing Category NameANDA
Application NumberANDA206465
ManufacturerQuallent Pharmaceuticals Health LLC
Substance NameROSUVASTATIN CALCIUM
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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