Crestor
Approved
Approval ID
3bf80420-7482-44c0-a117-30793ba89544
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-659
Application NumberNDA021366
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2010
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Rosuvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-288
Application NumberNDA021366
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2010
FDA Product Classification
INGREDIENTS (10)
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Rosuvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-759
Application NumberNDA021366
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2010
FDA Product Classification
INGREDIENTS (7)
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Rosuvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-287
Application NumberNDA021366
Product Classification
M
Marketing Category
C73594
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2010
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT