CRESTOR (Page 9 of 9)

Rosuvastatin Calcium

Label ImageLabel Image
CRESTOR rosuvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-4634(NDC:0310-0755)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
HYPROMELLOSES
TRIACETIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code 5;crestor
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-4634-9 1 TABLET, FILM COATED in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021366 08/18/2003
Labeler — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-4634)

Revised: 08/2016 Carilion Materials Management

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