Label: AMLODIPINE AND ATORVASTATIN tablet, film coated

  • NDC Code(s): 70771-1457-1, 70771-1457-3, 70771-1457-4, 70771-1457-9, view more
    70771-1458-1, 70771-1458-3, 70771-1458-4, 70771-1458-9, 70771-1459-1, 70771-1459-3, 70771-1459-4, 70771-1459-9, 70771-1460-1, 70771-1460-3, 70771-1460-4, 70771-1460-9, 70771-1461-1, 70771-1461-3, 70771-1461-4, 70771-1461-9, 70771-1462-1, 70771-1462-3, 70771-1462-4, 70771-1462-9, 70771-1463-1, 70771-1463-3, 70771-1463-4, 70771-1463-9, 70771-1464-1, 70771-1464-3, 70771-1464-4, 70771-1464-9, 70771-1465-1, 70771-1465-3, 70771-1465-4, 70771-1465-9, 70771-1466-1, 70771-1466-3, 70771-1466-4, 70771-1466-9, 70771-1467-1, 70771-1467-3, 70771-1467-4, 70771-1467-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 5, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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)