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 use Initial U.S. Approval: 2003
Approved
Approval ID
989dffcf-0254-439d-9f3f-3b0e9d32de0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
UMEDICA LABORATORIES PRIVATE LIMITED
DUNS: 920635096
Products 4
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 Code60290-043
Application NumberANDA207626
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60290-045
Application NumberANDA207626
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60290-046
Application NumberANDA207626
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60290-044
Application NumberANDA207626
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM