Rosuvastatin

ROSUVASTATIN — rosuvastatin calcium tablet, film coated
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1481-3

Rosuvastatin Calcium Tablets, 5 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
(click image for full-size original)

NDC 70771-1482-3

Rosuvastatin Calcium Tablets, 10 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
(click image for full-size original)

NDC 70771-1483-3

Rosuvastatin Calcium Tablets, 20 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
(click image for full-size original)

NDC 70771-1484-3

Rosuvastatin Calcium Tablets, 40 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
(click image for full-size original)
ROSUVASTATIN
rosuvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1481
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
HYPROMELLOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 627
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1481-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1481-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1481-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1481-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1481-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1481-2 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1481-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206513 01/16/2020 07/09/2022
ROSUVASTATIN
rosuvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1482
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PINK (PINK) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 628
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1482-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1482-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1482-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1482-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1482-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1482-2 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1482-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206513 01/16/2020 07/09/2022
ROSUVASTATIN
rosuvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1483
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLACRILIN POTASSIUM
TITANIUM DIOXIDE
TRIACETIN
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (ORANGE) Score no score
Shape ROUND (ROUND) Size 9mm
Flavor Imprint Code 629
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1483-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1483-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1483-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1483-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1483-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1483-2 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1483-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206513 01/16/2020
ROSUVASTATIN
rosuvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1484
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ROSUVASTATIN CALCIUM (ROSUVASTATIN) ROSUVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
FD&C RED NO. 40
FERRIC OXIDE RED
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color PURPLE (LIGHT PURPLE) Score no score
Shape OVAL (OVAL) Size 16mm
Flavor Imprint Code 630
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1484-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1484-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1484-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1484-5 500 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1484-0 1000 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:70771-1484-2 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1484-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206513 01/16/2020 07/09/2022
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 863362789 ANALYSIS (70771-1481), ANALYSIS (70771-1482), ANALYSIS (70771-1483), ANALYSIS (70771-1484), MANUFACTURE (70771-1481), MANUFACTURE (70771-1482), MANUFACTURE (70771-1483), MANUFACTURE (70771-1484)

Revised: 07/2022 Zydus Lifesciences Limited

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