Amlodipine and atorvastatin

Basic Information

Product Name

FDA Product Code

68382-425

Regulatory Information

NDC Product Code

68382-425

Application Number

ANDA207762

Marketing Category

C73584

Effective Date

October 31, 2020

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

AMLODIPINE BESYLATE

Quantity: 2.5 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

CALCIUM CARBONATE

Code: H0G9379FGK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

ATORVASTATIN CALCIUM TRIHYDRATE

Quantity: 20 mg in 1 1

Code: 48A5M73Z4Q

Class Code: ACTIM

Active Moieties

AMLODIPINE

Code: 1J444QC288

ATORVASTATIN

Code: A0JWA85V8F

Basic Information

Regulatory Information

Company Information

Active Ingredients

CALCIUM CARBONATE

CELLULOSE, MICROCRYSTALLINE

CROSCARMELLOSE SODIUM

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

HYPROMELLOSES

MAGNESIUM STEARATE

POLYSORBATE 80

SILICON DIOXIDE

TALC

TITANIUM DIOXIDE

STARCH, CORN

Active Moieties

AMLODIPINE

ATORVASTATIN