NDC Code(s) : 16252-615-30, 16252-615-90, 16252-615-50, 16252-616-30, 16252-616-90, 16252-616-50, 16252-617-30, 16252-617-50, 16252-617-90, 16252-618-30, 16252-618-90, 16252-618-50
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rosuvastatin CalciumRosuvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16252-615
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CARBONATE MONOHYDRATE(UNII: 2A1Q1Q3557)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3500(UNII: FVS1AZD90Y)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code RU5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16252-615-301 in 1 CARTON 05/02/2016
130 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:16252-615-901 in 1 CARTON 05/02/2016
290 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:16252-615-501 in 1 CARTON 16/08/2016
3500 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079167 05/02/2016 11/30/2018
Rosuvastatin CalciumRosuvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16252-616
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CARBONATE MONOHYDRATE(UNII: 2A1Q1Q3557)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3500(UNII: FVS1AZD90Y)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code RU10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16252-616-301 in 1 CARTON 05/02/2016
130 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:16252-616-901 in 1 CARTON 05/02/2016
290 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:16252-616-501 in 1 CARTON 18/08/2016
3500 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079167 05/02/2016 10/30/2018
Rosuvastatin CalciumRosuvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16252-617
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CARBONATE MONOHYDRATE(UNII: 2A1Q1Q3557)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3500(UNII: FVS1AZD90Y)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code RU20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16252-617-301 in 1 CARTON 05/02/2016
130 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:16252-617-501 in 1 CARTON 23/08/2016
2500 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:16252-617-901 in 1 CARTON 05/02/2016
390 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079167 05/02/2016 10/31/2018
Rosuvastatin CalciumRosuvastatin calcium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16252-618
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
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM CARBONATE MONOHYDRATE(UNII: 2A1Q1Q3557)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3500(UNII: FVS1AZD90Y)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code RU40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16252-618-301 in 1 CARTON 05/02/2016
130 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:16252-618-901 in 1 CARTON 31/08/2016
290 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:16252-618-501 in 1 CARTON 23/08/2016
3500 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079167 05/02/2016 10/31/2018

PRINCIPAL DISPLAY PANEL

NDC 16252-615-30
Rosuvastatin
Calcium Tablets
5 mg
PHARMACIST: Dispense the accompanying Patient Information to each patient.
30 Tablets
Rx Only

1

PRINCIPAL DISPLAY PANEL

NDC 16252-616-30
Rosuvastatin
Calcium Tablets
10 mg
PHARMACIST: Dispense the accompanying Patient Information to each patient.
30 Tablets
Rx Only

1

PRINCIPAL DISPLAY PANEL

NDC 16252-617-30
Rosuvastatin
Calcium Tablets
20 mg
PHARMACIST: Dispense the accompanying Patient Information to each patient.
30 Tablets
Rx Only

1

PRINCIPAL DISPLAY PANEL

NDC 16252-618-30
Rosuvastatin
Calcium Tablets
40 mg
PHARMACIST: Dispense the accompanying Patient Information to each patient.
30 Tablets
Rx Only


1