Rosuvastatin Calcium
These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS.ROSUVASTATIN tablets, for oral useInitial U.S. Approval: 2003
Approved
Approval ID
c28dd003-e432-4519-a7b2-db7c7876aa80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4039
Application NumberANDA201619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2019
FDA Product Classification
INGREDIENTS (9)
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT