Amlodipine Besylate

Basic Information

Product Name

Amlodipine Besylate

FDA Product Code

65862-103

Regulatory Information

NDC Product Code

65862-103

Application Number

ANDA078021

Marketing Category

C73584

Effective Date

March 16, 2022

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral use Initial U.S. Approval: 1992

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

AMLODIPINE BESYLATE

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

AMLODIPINE

Code: 1J444QC288

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

MICROCRYSTALLINE CELLULOSE

MAGNESIUM STEARATE

SODIUM STARCH GLYCOLATE TYPE A POTATO

Active Moieties

AMLODIPINE