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 useInitial U.S. Approval: 2004

Approved

Approval ID

594bfb20-fbb0-4c2b-8e89-430e20cb48d4

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 31, 2020

Manufacturers

FDA

Zydus Pharmaceuticals (USA) Inc.

DUNS: 156861945

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 Code68382-433

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

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 Code68382-432

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

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 Code68382-424

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (13)

AMLODIPINE BESYLATEActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

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 Code68382-434

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

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 Code68382-431

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (14)

AMLODIPINE BESYLATEActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

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 Code68382-430

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (13)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

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 Code68382-427

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (13)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

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 Code68382-429

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (13)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

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 Code68382-428

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (13)

AMLODIPINE BESYLATEActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

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 Code68382-426

Application NumberANDA207762

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine and atorvastatin

Product Specifications

Route of AdministrationORAL

Effective DateOctober 31, 2020

FDA Product Classification

INGREDIENTS (13)

AMLODIPINE BESYLATEActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61U

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

ATORVASTATIN CALCIUM TRIHYDRATEActive

Quantity: 40 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 (14)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

Amlodipine and atorvastatin

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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