Amlodipine besylate and Atorvastatin calcium

These highlights do not include all the information needed to use Initial U.S. Approval: 2004

Approved

Approval ID

abee4a34-89cc-d886-192c-32582ab8f024

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 16, 2021

Manufacturers

FDA

Dr. Reddy's Laboratories Inc

DUNS: 802315887

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 Code43598-320

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (15)

amlodipine besylateActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

Atorvastatin Calcium TrihydrateActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-317

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (15)

amlodipine besylateActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

Atorvastatin Calcium TrihydrateActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-323

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (15)

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

amlodipine besylateActive

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

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 besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-314

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (15)

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

amlodipine besylateActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

Atorvastatin Calcium TrihydrateActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-321

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (16)

amlodipine besylateActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

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 besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-316

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (15)

amlodipine besylateActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

Atorvastatin Calcium TrihydrateActive

Quantity: 40 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-315

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (16)

amlodipine besylateActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

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 besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-319

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (15)

amlodipine besylateActive

Quantity: 5 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

Atorvastatin Calcium TrihydrateActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-318

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (16)

amlodipine besylateActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

Atorvastatin Calcium TrihydrateActive

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

Amlodipine besylate and Atorvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43598-313

Application NumberANDA203874

Product Classification

Marketing Category

C73584

Generic Name

Amlodipine besylate and Atorvastatin calcium

Product Specifications

Route of AdministrationORAL

Effective DateFebruary 16, 2021

FDA Product Classification

INGREDIENTS (16)

sodium lauryl sulfateInactive

Code: 368GB5141J

Classification: IACT

polyethylene glycol 3350Inactive

Code: G2M7P15E5P

Classification: IACT

Polyvinyl Alcohol, UnspecifiedInactive

Code: 532B59J990

Classification: IACT

amlodipine besylateActive

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Classification: ACTIM

silicon dioxideInactive

Code: ETJ7Z6XBU4

Classification: IACT

starch, cornInactive

Code: O8232NY3SJ

Classification: IACT

Hydrogenated Soybean LecithinInactive

Code: H1109Z9J4N

Classification: IACT

talcInactive

Code: 7SEV7J4R1U

Classification: IACT

titanium dioxideInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

magnesium stearateInactive

Code: 70097M6I30

Classification: IACT

cellulose, microcrystallineInactive

Code: OP1R32D61U

Classification: IACT

CrospovidoneInactive

Code: 2S7830E561

Classification: IACT

Hydroxypropyl Cellulose, UnspecifiedInactive

Code: 9XZ8H6N6OH

Classification: IACT

sodium bicarbonateInactive

Code: 8MDF5V39QO

Classification: IACT

Atorvastatin Calcium TrihydrateActive

Quantity: 80 mg in 1 1

Code: 48A5M73Z4Q

Classification: ACTIM

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Amlodipine besylate and Atorvastatin calcium

Products 10

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 (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 (16)

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 (16)

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 (16)

Amlodipine besylate and Atorvastatin calcium

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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