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
2aa6d21f-426a-42b0-aa96-4cc47f97f7ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
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 Code50090-4738
Application NumberANDA079172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2022
FDA Product Classification
INGREDIENTS (10)
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT