ROSUVASTATIN- rosuvastatin tablet, film coated
Zydus Lifesciences Limited

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ROSUVASTATIN TABLETS

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)	ROSUVASTATIN	5 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	YELLOW (YELLOW)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	627
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1481-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
2	NDC:70771-1481-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
3	NDC:70771-1481-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
4	NDC:70771-1481-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
5	NDC:70771-1481-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
6	NDC:70771-1481-2	10 in 1 CARTON	01/16/2020	07/09/2022
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)	ROSUVASTATIN	10 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	PINK (PINK)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	628
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1482-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
2	NDC:70771-1482-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
3	NDC:70771-1482-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
4	NDC:70771-1482-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
5	NDC:70771-1482-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
6	NDC:70771-1482-2	10 in 1 CARTON	01/16/2020	07/09/2022
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)	ROSUVASTATIN	20 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	629
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1483-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
2	NDC:70771-1483-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
3	NDC:70771-1483-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
4	NDC:70771-1483-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
5	NDC:70771-1483-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
6	NDC:70771-1483-2	10 in 1 CARTON	01/16/2020	07/09/2022
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206513	01/16/2020	07/09/2022

ROSUVASTATIN
rosuvastatin tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1484
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)	ROSUVASTATIN	40 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	PURPLE (LIGHT PURPLE)	Score	no score
Shape	OVAL (OVAL)	Size	16mm
Flavor		Imprint Code	630
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1484-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
2	NDC:70771-1484-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
3	NDC:70771-1484-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
4	NDC:70771-1484-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
5	NDC:70771-1484-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/16/2020	07/09/2022
6	NDC:70771-1484-2	10 in 1 CARTON	01/16/2020	07/09/2022
6		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206513	01/16/2020	07/09/2022

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1481, 70771-1482, 70771-1483, 70771-1484) , MANUFACTURE(70771-1481, 70771-1482, 70771-1483, 70771-1484)

Revised: 8/2024

Document Id: 5a150385-534d-4d1d-96e8-cac9bea0d172

Set id: 460f9985-cfe3-43ca-a023-6ebf98b87880

Version: 5

Effective Time: 20240820

Zydus Lifesciences Limited