Caduet

Approved

Approval ID

909fad96-a941-443a-a39f-4f93607410fb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 30, 2009

Manufacturers

FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 10

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5420

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (14)

ATORVASTATIN CALCIUMActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5179

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

ATORVASTATIN CALCIUMActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5523

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (15)

ATORVASTATIN CALCIUMActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5699

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5567

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (15)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ATORVASTATIN CALCIUMActive

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5200

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (15)

ATORVASTATIN CALCIUMActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-1207

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

ATORVASTATIN CALCIUMActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-3287

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

ATORVASTATIN CALCIUMActive

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5209

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (15)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

ATORVASTATIN CALCIUMActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

amlodipine besylate and atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code54868-5672

Application NumberNDA021540

Product Classification

Marketing Category

C73594

Generic Name

amlodipine besylate and atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateNovember 30, 2009

FDA Product Classification

INGREDIENTS (14)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIB

ATORVASTATIN CALCIUMActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIB

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOLInactive

Code: 532B59J990

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSEInactive

Code: RFW2ET671P

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

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Caduet

Products 10

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

amlodipine besylate and atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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