CRESTOR
These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR.CRESTOR (rosuvastatin calcium) tabletsInitial U.S. Approval: 2003
Approved
Approval ID
598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2017
Manufacturers
FDA
Avera McKennan Hospital
DUNS: 068647668
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rosuvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69189-0752
Application NumberNDA021366
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 24, 2017
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT