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

NDC 70771-1482-3

Rosuvastatin Calcium Tablets, 10 mg

30 Tablets

Rx only

NDC 70771-1483-3

Rosuvastatin Calcium Tablets, 20 mg

30 Tablets

Rx only

NDC 70771-1484-3

Rosuvastatin Calcium Tablets, 40 mg

30 Tablets

Rx only

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