CRESTOR

Basic Information

Product Name

CRESTOR

FDA Product Code

69189-0752

Regulatory Information

NDC Product Code

69189-0752

Application Number

NDA021366

Marketing Category

C73594

Effective Date

March 24, 2017

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR.CRESTOR (rosuvastatin calcium) tabletsInitial U.S. Approval: 2003

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

ROSUVASTATIN CALCIUM

Quantity: 20 mg in 1 1

Code: 83MVU38M7Q

Class Code: ACTIM

TRIBASIC CALCIUM PHOSPHATE

Code: 91D9GV0Z28

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

ROSUVASTATIN

Code: 413KH5ZJ73

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

CELLULOSE, MICROCRYSTALLINE

TRIBASIC CALCIUM PHOSPHATE

CROSPOVIDONE (15 MPA.S AT 5%)

TRIACETIN

FERRIC OXIDE RED

MAGNESIUM STEARATE

HYPROMELLOSES

TITANIUM DIOXIDE

Active Moieties

ROSUVASTATIN