NDC Code(s) : 55154-6926-8
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CRESTORRosuvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-6926(NDC:0310-0752)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
CROSPOVIDONE (15 MPA.S AT 5%)(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code 20;crestor
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-6926-81260 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021366 12/01/2010 09/30/2018

PRINCIPAL DISPLAY PANEL

Crestor

(rosuvastatin calcium)

tablets

20 mg

Contains Approximately 1260 Tablets

bottle label