NDC Code(s) : 54569-5746-0, 54569-5746-1, 54569-5600-0, 54569-5600-1, 54569-5672-0, 54569-5672-1
Packager : A-S Medication Solutions LLC

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:54569-5746(NDC:0310-0755)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN CALCIUM - UNII:83MVU38M7Q) 		ROSUVASTATIN CALCIUM5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSE(UNII: 3NXW29V3WO)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSPOVIDONE(UNII: 68401960MK)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
Product Characteristics
Color YELLOW Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code 5;crestor
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5746-030 in 1 BOTTLE, DISPENSING
2NDC:54569-5746-190 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021366 10/26/2005
CRESTORRosuvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5600(NDC:0310-0751)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN CALCIUM - UNII:83MVU38M7Q) 		ROSUVASTATIN CALCIUM10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE(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 7 mm
Flavor Imprint Code 10;crestor
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5600-030 in 1 BOTTLE, DISPENSING
2NDC:54569-5600-190 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021366 09/02/2004
CRESTORRosuvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5672(NDC:0310-0752)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN CALCIUM - UNII:83MVU38M7Q) 		ROSUVASTATIN CALCIUM20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
CROSPOVIDONE(UNII: 68401960MK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE(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:54569-5672-030 in 1 BOTTLE, DISPENSING
2NDC:54569-5672-190 in 1 BOTTLE, DISPENSING
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021366 04/14/2005

PRINCIPAL DISPLAY PANEL

Crestor 5 mg LabelCrestor 5 mg LabelCrestor 5 mg Label