NDC Code(s) : 47335-582-83, 47335-582-81, 47335-582-18, 47335-583-83, 47335-583-81, 47335-583-18, 47335-584-83, 47335-584-81, 47335-584-18, 47335-585-83, 47335-585-81, 47335-585-18
Packager : Sun Pharmaceutical Industries, Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:47335-582
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND (Circular) Size 5 mm
Flavor Imprint Code S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-582-8330 in 1 BOTTLE Type 0: Not a Combination Product23/06/2023
2NDC:47335-582-8190 in 1 BOTTLE Type 0: Not a Combination Product03/01/2021
3NDC:47335-582-181000 in 1 BOTTLE Type 0: Not a Combination Product23/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079169 03/01/2021
Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:47335-583
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color PINK Score no score
Shape ROUND (Circular) Size 6 mm
Flavor Imprint Code 583
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-583-8330 in 1 BOTTLE Type 0: Not a Combination Product23/06/2023
2NDC:47335-583-8190 in 1 BOTTLE Type 0: Not a Combination Product03/01/2021
3NDC:47335-583-181000 in 1 BOTTLE Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079169 03/01/2021
Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:47335-584
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color PINK Score no score
Shape ROUND (Circular) Size 8 mm
Flavor Imprint Code 584
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-584-8330 in 1 BOTTLE Type 0: Not a Combination Product23/06/2023
2NDC:47335-584-8190 in 1 BOTTLE Type 0: Not a Combination Product03/01/2021
3NDC:47335-584-181000 in 1 BOTTLE Type 0: Not a Combination Product23/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079169 03/01/2021
Rosuvastatin CalciumRosuvastatin Calcium TABLET, FILM COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:47335-585
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM(UNII: 83MVU38M7Q)
(ROSUVASTATIN - UNII:413KH5ZJ73) 		ROSUVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code 585
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-585-8330 in 1 BOTTLE Type 0: Not a Combination Product03/01/2021
2NDC:47335-585-8190 in 1 BOTTLE Type 0: Not a Combination Product23/06/2023
3NDC:47335-585-181000 in 1 BOTTLE Type 0: Not a Combination Product23/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079169 03/01/2021

LABELER - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Sun Pharmaceutical Industries Limited 650445203 ANALYSIS(47335-582, 47335-583, 47335-584, 47335-585), MANUFACTURE(47335-582, 47335-583, 47335-584, 47335-585)

PRINCIPAL DISPLAY PANEL

NDC 47335-582-81 
Rosuvastatin Tablets
5 mg
PHARMACIST: Dispense with Patient Information
Rx only
90 Tablets
SUN PHARMA

rosuvastatin-label-5mg

PRINCIPAL DISPLAY PANEL

NDC 47335-583-81
Rosuvastatin Tablets 
10 mg

PHARMACIST: Dispense with Patient Information
Rx only
90 Tablets
SUN PHARMA

rosuvastatin-label-10mg

PRINCIPAL DISPLAY PANEL

NDC 47335-584-81
Rosuvastatin Tablets
20 mg

PHARMACIST: Dispense with Patient Information
Rx only
90 Tablets
SUN PHARMA

rosuvastatin-label-20mg.jpg

PRINCIPAL DISPLAY PANEL

NDC 47335-585-81
Rosuvastatin Tablets
40 mg

PHARMACIST: Dispense with Patient Information
Rx only
90 Tablets
SUN PHARMA

rosuvastatin-label-40mg