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

Rosuvastatin Ca Tablets

NDC 70771-1482-3

Rosuvastatin Calcium Tablets, 10 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets

NDC 70771-1483-3

Rosuvastatin Calcium Tablets, 20 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets

NDC 70771-1484-3

Rosuvastatin Calcium Tablets, 40 mg

30 Tablets

Rx only

Rosuvastatin Ca Tablets
ROSUVASTATIN 
rosuvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1481
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (YELLOW) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 627
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1481-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
2NDC:70771-1481-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
3NDC:70771-1481-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
4NDC:70771-1481-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
5NDC:70771-1481-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
6NDC:70771-1481-210 in 1 CARTON01/16/202007/09/2022
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20651301/16/202007/09/2022
ROSUVASTATIN 
rosuvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINK (PINK) Scoreno score
ShapeROUND (ROUND) Size7mm
FlavorImprint Code 628
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1482-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
2NDC:70771-1482-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
3NDC:70771-1482-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
4NDC:70771-1482-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
5NDC:70771-1482-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
6NDC:70771-1482-210 in 1 CARTON01/16/202007/09/2022
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20651301/16/202007/09/2022
ROSUVASTATIN 
rosuvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1483
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN20 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (ORANGE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 629
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1483-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
2NDC:70771-1483-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
3NDC:70771-1483-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
4NDC:70771-1483-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
5NDC:70771-1483-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/2020
6NDC:70771-1483-210 in 1 CARTON01/16/2020
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20651301/16/2020
ROSUVASTATIN 
rosuvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1484
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73) ROSUVASTATIN40 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLE (LIGHT PURPLE) Scoreno score
ShapeOVAL (OVAL) Size16mm
FlavorImprint Code 630
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1484-330 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
2NDC:70771-1484-990 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
3NDC:70771-1484-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
4NDC:70771-1484-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
5NDC:70771-1484-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/16/202007/09/2022
6NDC:70771-1484-210 in 1 CARTON01/16/202007/09/2022
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20651301/16/202007/09/2022
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1481, 70771-1482, 70771-1483, 70771-1484) , MANUFACTURE(70771-1481, 70771-1482, 70771-1483, 70771-1484)

Revised: 7/2022
Document Id: adfb8a09-06b0-466b-9782-2189364f09fd
Set id: 460f9985-cfe3-43ca-a023-6ebf98b87880
Version: 4
Effective Time: 20220709
 
Zydus Lifesciences Limited