Rosuvastatin Calcium
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 useInitial U.S. Approval: 2003
Approved
Approval ID
3066f572-e3db-4bf8-b9ee-bd32d9ed8c13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-865
Application NumberANDA079170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (10)
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-864
Application NumberANDA079170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-872
Application NumberANDA079170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (10)
ROSUVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
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 Code63187-860
Application NumberANDA079170
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT