Rosuvastatin
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
616fd0c5-39c8-4276-9bcd-b045a08d08de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rosuvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55700-575
Application NumberANDA207616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (14)
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Rosuvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55700-574
Application NumberANDA207616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (14)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT