NDC Code(s) : 0069-2150-30, 0069-2170-30, 0069-2190-30, 0069-2260-30, 0069-2160-30, 0069-2180-30, 0069-2250-30, 0069-2270-30, 0069-6180-30, 0069-6323-30, 0069-6565-30, 0069-6747-30, 0069-7810-30, 0069-7232-30, 0069-7654-30, 0069-7476-30
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code Pfizer;CDT;051
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2150-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004 04/30/2023
Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code Pfizer;CDT;052
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2170-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004 04/30/2023
Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2190
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code Pfizer;CDT;054
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2190-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004 08/08/2023
Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2260
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code Pfizer;CDT;058
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2260-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004
Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code Pfizer;CDT;101
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2160-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004 12/31/2022
Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code Pfizer;CDT;102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2180-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004 04/30/2023
Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2250
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code Pfizer;CDT;104
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2250-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004 07/31/2023
Caduetamlodipine besylate and atorvastatin calcium TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-2270
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code Pfizer;CDT;108
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-2270-3030 in 1 BOTTLE Type 0: Not a Combination Product30/01/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/30/2004 04/30/2023
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-6180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code Pfizer;CDT;051
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-6180-3030 in 1 BOTTLE Type 0: Not a Combination Product31/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 08/31/2022
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-6323
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code Pfizer;CDT;052
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-6323-3030 in 1 BOTTLE Type 0: Not a Combination Product31/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 08/31/2022
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-6565
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code Pfizer;CDT;054
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-6565-3030 in 1 BOTTLE Type 0: Not a Combination Product31/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 08/31/2022
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-6747
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code Pfizer;CDT;058
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-6747-3030 in 1 BOTTLE Type 0: Not a Combination Product31/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 08/31/2022
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-7810
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code Pfizer;CDT;101
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-7810-3030 in 1 BOTTLE Type 0: Not a Combination Product06/06/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 06/06/2022
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-7232
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code Pfizer;CDT;102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-7232-3030 in 1 BOTTLE Type 0: Not a Combination Product31/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 08/31/2022
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-7654
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code Pfizer;CDT;104
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-7654-3030 in 1 BOTTLE Type 0: Not a Combination Product31/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 08/31/2022
Caduetamlodipine and atorvastatin TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-7476
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
ATORVASTATIN CALCIUM TRIHYDRATE(UNII: 48A5M73Z4Q)
(ATORVASTATIN - UNII:A0JWA85V8F) 		ATORVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE(UNII: H0G9379FGK)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
WATER(UNII: 059QF0KO0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code Pfizer;CDT;108
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-7476-3030 in 1 BOTTLE Type 0: Not a Combination Product31/08/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 08/31/2022

LABELER - Pfizer Laboratories Div Pfizer Inc(134489525)

REGISTRANT - Pfizer Inc(113480771)

Establishment
Name Address ID/FEI Business Operations
Viatris Pharmaceuticals LLC 829084545 API MANUFACTURE(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810)

Establishment
Name Address ID/FEI Business Operations
Pharmacia & Upjohn Company LLC 618054084 PACK(0069-2150, 0069-2170, 0069-2190, 0069-2260, 0069-2160, 0069-2180, 0069-2250, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7810, 0069-7232, 0069-7654, 0069-7476), LABEL(0069-2150, 0069-2170, 0069-2190, 0069-2260, 0069-2160, 0069-2180, 0069-2250, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7810, 0069-7232, 0069-7654, 0069-7476)

Establishment
Name Address ID/FEI Business Operations
Viatris Pharmaceuticals LLC 829084552 PACK(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810)

Establishment
Name Address ID/FEI Business Operations
Pfizer Ireland Pharmaceuticals 985052076 ANALYSIS(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810), API MANUFACTURE(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810)

Establishment
Name Address ID/FEI Business Operations
Pfizer Manufacturing Deutschland GmbH 341970073 ANALYSIS(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810), MANUFACTURE(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810), PACK(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810), LABEL(0069-2150, 0069-2160, 0069-2170, 0069-2180, 0069-2190, 0069-2250, 0069-2260, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7232, 0069-7476, 0069-7654, 0069-7810)

Establishment
Name Address ID/FEI Business Operations
Pfizer Inc 943955690 ANALYSIS(0069-2150, 0069-2170, 0069-2190, 0069-2260, 0069-2160, 0069-2180, 0069-2250, 0069-2270, 0069-6180, 0069-6323, 0069-6565, 0069-6747, 0069-7810, 0069-7232, 0069-7654, 0069-7476)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mg/10 mg Tablet Bottle Label

Pfizer
NDC 0069-2150-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

5 mg/10 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/10 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mg/20 mg Tablet Bottle Label

Pfizer
NDC 0069-2170-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

5 mg/20 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/20 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mg/40 mg Tablet Bottle Label

Pfizer
NDC 0069-2190-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

5 mg/40 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/40 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mg/80 mg Tablet Bottle Label

Pfizer
NDC 0069-2260-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

5 mg/80 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/80 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg/10 mg Tablet Bottle Label

Pfizer
NDC 0069-2160-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

10 mg/10 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/10 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg/20 mg Tablet Bottle Label

Pfizer
NDC 0069-2180-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

10 mg/20 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/20 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg/40 mg Tablet Bottle Label

Pfizer
NDC 0069-2250-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

10 mg/40 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/40 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg/80 mg Tablet Bottle Label

Pfizer
NDC 0069-2270-30

Caduet®

(amlodipine besylate/
atorvastatin calcium)

Tablets

10 mg/80 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/80 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-6180-30

Caduet®
(amlodipine and
atorvastatin)
tablets

5 mg/10 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/10 mg Tablet Bottle Label - 6180-30

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-6323-30

Caduet®
(amlodipine and
atorvastatin)
tablets

5 mg/20 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/20 mg Tablet Bottle Label - 6323-30

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-6565-30

Caduet®
(amlodipine and
atorvastatin)
tablets

5 mg/40 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/40 mg Tablet Bottle Label - 6565-30

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-6747-30

Caduet®
(amlodipine and
atorvastatin)
tablets

5 mg/80 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/80 mg Tablet Bottle Label - 6747-30

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-7810-30

Caduet®
(amlodipine and
atorvastatin)
tablets

10 mg/10 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/10 mg Tablet Bottle Label - 7810-30

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-7232-30

Caduet®
(amlodipine and
atorvastatin)
tablets

10 mg/20 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/20 mg Tablet Bottle Label - 7232-30

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-7654-30

Caduet®
(amlodipine and
atorvastatin)
tablets

10 mg/40 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/40 mg Tablet Bottle Label - 7654-30

PRINCIPAL DISPLAY PANEL

Pfizer
NDC 0069-7476-30

Caduet®
(amlodipine and
atorvastatin)
tablets

10 mg/80 mg*

30 Tablets
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/80 mg Tablet Bottle Label - 7476-30