AMLODIPINE AND ATORVASTATIN- amlodipine and atorvastatin tablet, film coated 
Cadila Healthcare Limited

----------

AMLODIPINE AND ATORVASTATIN Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1457-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1458-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1459-3

Amlodipine and atorvastatin tablets USP, 2.5 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1460-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1461-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1462-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1463-3

Amlodipine and atorvastatin tablets USP, 5 mg/ 80 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1464-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 10 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1465-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 20 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1466-3

Amlodipine and atorvastatin tablets USP, 10 mg/ 40 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP

NDC 70771-1467-3

Amlodipine and atorvastatin tablets USP, 10 mg/80 mg

30 tablets

Rx only

Amlodipine and Atorvastatin Tablets, USP
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN80 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (BLUE) Scoreno score
ShapeOVAL (BICONVEX) Size17mm
FlavorImprint Code F14
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1467-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1467-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1467-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1467-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1457
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN10 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 424
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1457-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1457-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1457-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1457-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1458
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN20 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 425
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1458-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1458-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1458-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1458-410 in 1 BLISTER PACK; Type 0: Not a Combination Product05/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1459
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE2.5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN40 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 426
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1459-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1459-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1459-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1459-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1460
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN10 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code 427
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1460-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1460-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1460-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1460-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1461
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN20 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code 428
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1461-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1461-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1461-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1461-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1462
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN40 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size14mm
FlavorImprint Code 429
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1462-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1462-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1462-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1462-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1463
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN80 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVAL (OVAL) Size17mm
FlavorImprint Code 430
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1463-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1463-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1463-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1463-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1464
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN10 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (LIGHT BLUE TO BLUE) Scoreno score
ShapeOVAL (o) Size11mm
FlavorImprint Code 431
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1464-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1464-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1464-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1464-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1465
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN20 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (LIGHT BLUE TO BLUE) Scoreno score
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code 432
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1465-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1465-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1465-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1465-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
AMLODIPINE AND ATORVASTATIN 
amlodipine and atorvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1466
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN40 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUE (LIGHT BLUE TO BLUE) Scoreno score
ShapeOVAL (OVAL) Size14mm
FlavorImprint Code 433
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1466-330 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
2NDC:70771-1466-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
3NDC:70771-1466-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
4NDC:70771-1466-410 in 1 CARTON05/30/2019
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776205/30/2019
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1457, 70771-1458, 70771-1459, 70771-1460, 70771-1461, 70771-1462, 70771-1463, 70771-1464, 70771-1465, 70771-1466, 70771-1467) , MANUFACTURE(70771-1457, 70771-1458, 70771-1459, 70771-1460, 70771-1461, 70771-1462, 70771-1463, 70771-1464, 70771-1465, 70771-1466, 70771-1467)

Revised: 8/2020
Document Id: 65a8d920-f5bf-4acb-a1cf-efaaf5031c4c
Set id: 337b47f6-d4df-48ed-b19f-96fcbae3884b
Version: 3
Effective Time: 20200805
 
Cadila Healthcare Limited