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 use Initial U.S. Approval: 2003
Approved
Approval ID
ef882889-ce8e-0992-c2dc-d00477e411f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2019
Manufacturers
FDA
Jubilant Cadista Pharmaceuticals Inc.
DUNS: 022490515
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 Code59746-430
Application NumberANDA207062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2018
FDA Product Classification
INGREDIENTS (13)
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Calcium Phosphate, Dibasic, DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Fd&c Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Crospovidone (15 Mpa.s At 5%)Inactive
Code: 68401960MK
Classification: IACT
Fd&c Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Rosuvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-431
Application NumberANDA207062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2018
FDA Product Classification
INGREDIENTS (13)
ROSUVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Calcium Phosphate, Dibasic, DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Fd&c Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Fd&c Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Crospovidone (15 Mpa.s At 5%)Inactive
Code: 68401960MK
Classification: IACT
Rosuvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-428
Application NumberANDA207062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2018
FDA Product Classification
INGREDIENTS (13)
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Calcium Phosphate, Dibasic, DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Crospovidone (15 Mpa.s At 5%)Inactive
Code: 68401960MK
Classification: IACT
Fd&c Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
D&c Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Fd&c Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Rosuvastatin calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-429
Application NumberANDA207062
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2018
FDA Product Classification
INGREDIENTS (13)
Calcium Phosphate, Dibasic, DihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Fd&c Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Fd&c Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Fd&c Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Crospovidone (15 Mpa.s At 5%)Inactive
Code: 68401960MK
Classification: IACT