ATORVASTATIN CALCIUM- atorvastatin calcium tablet 
Zydus Lifesciences Limited

----------

ATORVASTATIN CALCIUM tablets, for oral use

NDC 70771-1875-9           

Atorvastatin Calcium Tablets, USP 10 mg

Rx Only

90 Tablets

Atorvastatin Calcium Tablets, 10 mg

NDC 70771-1876-9

Atorvastatin Calcium Tablets, USP 20 mg

Rx Only

90 Tablets

Atorvastatin Calcium Tablets, 20 mg

NDC 70771-1877-9

Atorvastatin Calcium Tablets, USP 40 mg

Rx Only

90 Tablets

Atorvastatin Calcium Tablets, 40 mg

NDC 70771-1878-9

Atorvastatin Calcium Tablets, USP 80 mg

Rx Only

90 Tablets

Atorvastatin Calcium Tablets, 80 mg
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1875
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN10 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint Code 1777
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1875-990 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
2NDC:70771-1875-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
3NDC:70771-1875-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653606/12/2024
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1876
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN20 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVAL (OVAL) Size10mm
FlavorImprint Code 1775
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1876-990 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
2NDC:70771-1876-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
3NDC:70771-1876-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653606/12/2024
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1877
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN40 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE SODIUM PHOSPHATE (UNII: E6S1NJ4Y5Q)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVAL (OVAL) Size13mm
FlavorImprint Code 1772
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1877-990 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
2NDC:70771-1877-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
3NDC:70771-1877-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653606/12/2024
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1878
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN80 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeOVAL (OVAL) Size17mm
FlavorImprint Code 1770
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1878-990 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
2NDC:70771-1878-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
3NDC:70771-1878-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653606/12/2024
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1875, 70771-1876, 70771-1877, 70771-1878) , MANUFACTURE(70771-1875, 70771-1876, 70771-1877, 70771-1878)

Revised: 6/2024
Document Id: 5c1edb38-cb2a-4f68-adde-e3cc5ee2d33d
Set id: 06028adf-fcb5-452c-ba67-ee53bc65c519
Version: 2
Effective Time: 20240617
 
Zydus Lifesciences Limited