Amlodipine and Atorvastatin

These highlights do not include all the information needed to use amlodipine and atorvastatin tablets safely and effectively. See full prescribing information for amlodipine and atorvastatin tablets. Amlodipine and atorvastatin tablets, for oral use Initial U.S. Approval: 2004

Approved

Approval ID

14124e56-77ba-426d-8f5a-dbe42eda1a20

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 31, 2023

Manufacturers

FDA

Prasco Laboratories

DUNS: 065969375

Products 10

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

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-272

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (16)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-273

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (16)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-271

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (16)

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-269

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (15)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-266

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (15)

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-270

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (16)

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-268

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (15)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-267

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (15)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-265

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (15)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine and Atorvastatin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code66993-264

Application NumberNDA021540

Product Classification

Marketing Category

C73605

Generic Name

Amlodipine and Atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateMarch 16, 2022

FDA Product Classification

INGREDIENTS (15)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYVINYL ALCOHOL, UNSPECIFIEDInactive

Code: 532B59J990

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 3000Inactive

Code: SA1B764746

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

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Amlodipine and Atorvastatin

Products 10

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

Amlodipine and Atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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