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
d58f1f63-4bb6-413c-9730-ded3e8078618
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 5
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 Code72205-003
Application NumberANDA208898
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (14)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-004
Application NumberANDA208898
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (14)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-027
Application NumberANDA208898
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (11)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-002
Application NumberANDA208898
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (11)
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-005
Application NumberANDA208898
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (14)
ROSUVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT