ATORVASTATIN CALCIUM- atorvastatin calcium tablet 
Cadila Healthcare Limited

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ATORVASTATIN CALCIUM TABLETS.

NDC 70771-1443-3

Atorvastatin Calcium Tablets, USP 10 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 10 mg

NDC 70771-1444-3

Atorvastatin Calcium Tablets, USP 20 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 20 mg

NDC 70771-1445-3

Atorvastatin Calcium Tablets, USP 40 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 40 mg

NDC 70771-1446-3

Atorvastatin Calcium Tablets, USP 80 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 80 mg
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1443
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 (110000 WAMW) (UNII: 5Y0974F5PW)  
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) Size9mm
FlavorImprint Code 249
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1443-410 in 1 CARTON11/21/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:70771-1443-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
3NDC:70771-1443-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
4NDC:70771-1443-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
5NDC:70771-1443-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
6NDC:70771-1443-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653611/21/2018
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1444
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 (110000 WAMW) (UNII: 5Y0974F5PW)  
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) Size11mm
FlavorImprint Code 250
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1444-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
2NDC:70771-1444-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
3NDC:70771-1444-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
4NDC:70771-1444-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
5NDC:70771-1444-410 in 1 CARTON11/21/2018
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:70771-1444-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653611/21/2018
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1445
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 (110000 WAMW) (UNII: 5Y0974F5PW)  
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) Size14mm
FlavorImprint Code 251
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1445-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
2NDC:70771-1445-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
3NDC:70771-1445-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
4NDC:70771-1445-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
5NDC:70771-1445-410 in 1 CARTON11/21/2018
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:70771-1445-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653611/21/2018
ATORVASTATIN CALCIUM 
atorvastatin calcium tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1446
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 (110000 WAMW) (UNII: 5Y0974F5PW)  
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) Size19mm
FlavorImprint Code 252
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1446-990 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
2NDC:70771-1446-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
3NDC:70771-1446-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
4NDC:70771-1446-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
5NDC:70771-1446-410 in 1 CARTON11/21/2018
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:70771-1446-330 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20653611/21/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1443, 70771-1444, 70771-1445, 70771-1446) , MANUFACTURE(70771-1443, 70771-1444, 70771-1445, 70771-1446)

Revised: 8/2020
Document Id: 680edb42-6751-4deb-8842-f537af534a22
Set id: cda119f2-54c8-4a08-b266-a0dbd214d2ce
Version: 4
Effective Time: 20200813
 
Cadila Healthcare Limited