"68382-627-01" National Drug Code (NDC)

Rosuvastatin 100 TABLET, FILM COATED in 1 BOTTLE (68382-627-01)
(Zydus Pharmaceuticals (USA) Inc.)

NDC Code68382-627-01
Package Description100 TABLET, FILM COATED in 1 BOTTLE (68382-627-01)
Product NDC68382-627
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameRosuvastatin
Non-Proprietary NameRosuvastatin
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20200116
Marketing Category NameANDA
Application NumberANDA206513
ManufacturerZydus Pharmaceuticals (USA) Inc.
Substance NameROSUVASTATIN CALCIUM
Strength5
Strength Unitmg/1
Pharmacy ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

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