Basic Information
Rosuvastatin
71205-044
Regulatory Information
71205-044
ANDA207616
C73584
November 1, 2018
USA
HIGHLIGHTS OF PRESCRIBING INFORMATION 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
HUMAN PRESCRIPTION DRUG LABEL
3
Company Information
079196022
Active Ingredients
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
CROSPOVIDONE (15 MPA.S AT 5%)
Code: 68401960MK
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SODIUM BICARBONATE
Code: 8MDF5V39QO
Class Code: IACT
TRIACETIN
Code: XHX3C3X673
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
Active Moieties
ROSUVASTATIN
Code: 413KH5ZJ73