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Amlodipine

Generic Name
Amlodipine
Brand Names
Amlobenz, Azor, Caduet, Dafiro, Exforge, Exforge Hct, Katerzia, Lotrel, Norliqva, Norvasc, Prestalia, Tribenzor, Twynsta, Viacoram, Amlodipine / Valsartan Mylan
Drug Type
Small Molecule
Chemical Formula
C20H25ClN2O5
CAS Number
88150-42-9
Unique Ingredient Identifier
1J444QC288

Overview

Amlodipine, initially approved by the FDA in 1987, is a popular antihypertensive drug belonging to the group of drugs called dihydropyridine calcium channel blockers. Due to their selectivity for the peripheral blood vessels, dihydropyridine calcium channel blockers are associated with a lower incidence of myocardial depression and cardiac conduction abnormalities than other calcium channel blockers . Amlodipine is commonly used in the treatment of high blood pressure and angina. Amlodipine has antioxidant properties and an ability to enhance the production of nitric oxide (NO), an important vasodilator that decreases blood pressure . The option for single daily dosing of amlodipine is an attractive feature of this drug .

Indication

Amlodipine may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of the following conditions : • Hypertension • Coronary artery disease • Chronic stable angina • Vasospastic angina (Prinzmetal’s or Variant angina) • Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%

Associated Conditions

  • Cardiovascular Events
  • Chronic Stable Angina Pectoris
  • Coronary Artery Disease (CAD)
  • Homozygous Familial Hypercholesterolaemia (HoFH)
  • Hypertension
  • Hypertension, Essential Hypertension
  • Mixed Dyslipidemias
  • Primary Hypercholesterolemia
  • Vasospastic Angina

Research Report

Published: Jul 11, 2025

Comprehensive Analysis of Amlodipine (DB00381): A Foundational Cardiovascular Therapeutic

Executive Summary

Amlodipine is a third-generation dihydropyridine calcium channel blocker (CCB) that stands as a cornerstone therapy in cardiovascular medicine. Its clinical utility is anchored in its unique pharmacokinetic profile, characterized by a slow onset of action and a long elimination half-life, which translates to sustained, 24-hour blood pressure control with once-daily dosing and a favorable tolerability profile compared to earlier CCBs. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertension, chronic stable angina, and vasospastic angina. Furthermore, it holds a specific indication for reducing the risk of hospitalization for angina and the need for coronary revascularization procedures in patients with documented coronary artery disease (CAD). Its versatility is further demonstrated by its extensive use as a foundational component in numerous fixed-dose combination therapies, targeting multiple facets of cardiovascular risk. This report provides an exhaustive analysis of Amlodipine's chemical properties, pharmacological mechanisms, clinical evidence base, safety profile, and its comparative position within the broader class of antihypertensive agents.


Section 1: Molecular Profile and Pharmaceutical Formulations

1.1 Chemical Identity and Nomenclature

Amlodipine is a small molecule drug classified chemically as a fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative.[1] Its identity is precisely defined by established chemical and regulatory identifiers.

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2020/12/31
Phase 2
Completed
2020/09/22
Phase 4
Completed
2020/09/18
N/A
UNKNOWN
Ahn-Gook Pharmaceuticals Co.,Ltd
2020/08/20
Not Applicable
Completed
2020/08/19
Phase 3
Completed
2020/07/17
Phase 4
Recruiting
2020/06/17
Phase 4
Completed
2020/06/02
Phase 1
Completed
2020/04/27
Phase 3
Completed
2020/04/01
Phase 1
Terminated
Italo Biaggioni

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Apotex Corp.
60505-3489
ORAL
10 mg in 1 1
2/24/2023
Golden State Medical Supply, Inc.
51407-857
ORAL
5 mg in 1 1
3/8/2024
Rebel Distributors Corp
21695-916
ORAL
10 mg in 1 1
4/9/2010
Proficient Rx LP
71205-488
ORAL
10 mg in 1 1
10/1/2020
Lupin Pharmaceuticals, Inc.
68180-199
ORAL
10 mg in 1 1
12/15/2023
Dr.Reddy's Laboratories Limited
55111-341
ORAL
10 mg in 1 1
12/23/2022
Blenheim Pharmacal, Inc.
10544-113
ORAL
5 mg in 1 1
10/21/2015
A-S Medication Solutions
50090-5357
ORAL
5 mg in 1 1
9/8/2023
Pfizer Laboratories Div Pfizer Inc
0069-6565
ORAL
5 mg in 1 1
8/30/2023
Carilion Materials Management
68151-0995
ORAL
10 mg in 1 1
10/14/2015

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ACTAPIN TABLET 10MG
SIN13538P
TABLET
10 mg
8/25/2008
AMLONG-10 TABLET 10 mg
SIN12326P
TABLET
10 mg
6/23/2003
AMCARDIA 5 TABLET 5mg
SIN14584P
TABLET
5mg
8/12/2014
ANLODIN TABLET 10MG
SIN14629P
TABLET
10mg
9/22/2014
DAFIRO FILM-COATED TABLET 10MG/160MG
SIN14874P
TABLET, FILM COATED
10mg
10/16/2015
AMLOCORD 10 TABLET 10 MG
SIN16184P
TABLET
10 mg
5/7/2021
NATRIXAM MODIFIED RELEASE TABLET 1.5 mg/5 mg
SIN14901P
TABLET, MULTILAYER, EXTENDED RELEASE
5 mg
12/3/2015
TRIPLIXAM FILM COATED TABLET 5 mg/ 1.25 mg/ 10 mg
SIN15012P
TABLET, FILM COATED
10 mg
5/23/2016
Tenox tablets 5 mg
SIN14548P
TABLET
5 mg
5/19/2014
CO-MIDIS TABLETS 80MG/5MG
SIN16647P
TABLET
5 mg
11/24/2022

NMPA Drug Approvals

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Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/12.5 olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/10/12.5 mg film-coated tablet blister pack
312004
Medicine
A
11/21/2019
OLMAKAR HCT 20/5/12.5 olmesartan medoxomil/Amlodipine/Hydrochlorothiazide 20/5/12.5 mg film-coated tablet blister pack
311995
Medicine
A
11/21/2019
OLMAKAR HCT 40/5/25 olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/5/25 mg film-coated tablet blister pack
312012
Medicine
A
11/21/2019
BTC AMLODIPINE amlodipine (as besilate) 10 mg tablet blister pack
307474
Medicine
A
10/25/2018
APO-AMLODIPINE amlodipine 2.5 mg (as besilate) tablet bottle
135144
Medicine
A
12/13/2007
APOTEX-Amlodipine/Atorvastatin 10/10 amlodipine (as besilate)+atorvastatin (as ca propylene glycol solvate) 10mg/10mg film-coated tablet blister pack
214402
Medicine
A
7/10/2014
GENEPHARM AMLODIPINE amlodipine 5 mg (as besilate) tablet blister pack
135138
Medicine
A
12/13/2007
OLMESART AMLO HCT 40/5/25 olmesartan medoxomil/amlodipine (as besilate) and hydrochlorothiazide 40 mg/5 mg/25 mg tablet blister pack
288846
Medicine
A
4/23/2018
AMLO 10 amlodipine 10 mg (as besilate) tablet blister pack
201372
Medicine
A
10/22/2012
EXFORGE HCT 5/160/25 amlodipine/valsartan/hydrochlorothiazide tablet blister pack
158162
Medicine
A
4/9/2010

Health Canada Drug Approvals

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Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approval Date
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Malaysia NPRA Drug Approvals

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Strength
Approval Date
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UK EMC Drug Information

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Medicine Name
MA Holder
MA Number
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Active Ingredient
Authorization Date
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