Caduet (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

Caduet ®
(amlodipine besylate /
atorvastatin calcium)

2.5 mg/20 mg*

image of 2.5/20 mg package label

Caduet ®
(amlodipine besylate /
atorvastatin calcium)

2.5 mg/40 mg*

image of 2.5/40 mg package label

Caduet ®
(amlodipine besylate /atorvastatin calcium)

5 mg/10 mg*

image of 5/10 mg package label
(click image for full-size original)

Caduet ®
(amlodipine besylate /atorvastatin calcium)

5 mg/20 mg*

image of 5/20 mg package label
(click image for full-size original)

Caduet ®
(amlodipine besylate /
atorvastatin calcium)

5 mg/40 mg*

image of 5/40 mg package label

Caduet ®
(amlodipine besylate /
atorvastatin calcium)

5 mg/80 mg*

image of 5/80 mg package label

Caduet ®
(amlodipine besylate /
atorvastatin calcium)

10 mg/10 mg*

image of 10/10 mg package label

Caduet ®
(amlodipine besylate /atorvastatin calcium)

10 mg/20 mg*

image of 10/20 mg package label
(click image for full-size original)

Caduet ®
(amlodipine besylate /atorvastatin calcium)

10 mg/40 mg*

image of 10/40 mg package label
(click image for full-size original)

Caduet ®
(amlodipine besylate /atorvastatin calcium)

10 mg/80 mg*

image of 10/80 mg package label
(click image for full-size original)

CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5672(NDC:0069-2970)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 2.5 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 8mm
Flavor Imprint Code Pfizer;CDT;252
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5672-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 09/21/2006
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5699(NDC:0069-2980)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 2.5 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 10mm
Flavor Imprint Code Pfizer;CDT;254
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5699-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 11/02/2006
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3287(NDC:0069-2150)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 5 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 9mm
Flavor Imprint Code Pfizer;CDT;051
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3287-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-3287-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 04/15/2009
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1207(NDC:0069-2170)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 5 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 11mm
Flavor Imprint Code Pfizer;CDT;052
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-1207-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-1207-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/12/2005
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5179(NDC:0069-2190)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 5 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 14mm
Flavor Imprint Code Pfizer;CDT;054
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5179-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 11/11/2004
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5420(NDC:0069-2260)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 5 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
Product Characteristics
Color white Score no score
Shape OVAL Size 17mm
Flavor Imprint Code Pfizer;CDT;058
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5420-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 09/14/2005
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5567(NDC:0069-2160)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 10 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL Size 9mm
Flavor Imprint Code Pfizer;CDT;101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5567-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 11/30/2009
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5209(NDC:0069-2180)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 10 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL Size 11mm
Flavor Imprint Code Pfizer;CDT;102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5209-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5209-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 01/18/2005
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5200(NDC:0069-2250)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 10 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL Size 14mm
Flavor Imprint Code Pfizer;CDT;104
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5200-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5200-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 12/27/2004
CADUET amlodipine besylate and atorvastatin calcium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5523(NDC:0069-2270)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE BESYLATE 10 mg
ATORVASTATIN CALCIUM (ATORVASTATIN) ATORVASTATIN CALCIUM 80 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE
CROSCARMELLOSE SODIUM
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
HYDROXYPROPYL CELLULOSE
WATER
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3000
TALC
FD&C BLUE NO. 2
Product Characteristics
Color blue Score no score
Shape OVAL Size 17mm
Flavor Imprint Code Pfizer;CDT;108
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5523-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5523-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021540 04/15/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack, relabel

Revised: 11/2009 Physicians Total Care, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.