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Data updated: Mar 10, 2026

MOEXIPRIL HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE
Cardiovascular Approved 2003-05-08
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2003-05-08
Routes
ORAL
Dosage Forms
TABLET

Companies

GLENMARK PHARMS LTD CHARTWELL RX Teva Apotex
Active Ingredient: MOEXIPRIL HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE Approval History

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What MOEXIPRIL HYDROCHLORIDE Treats

1 indications

MOEXIPRIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
Source: FDA Label

MOEXIPRIL HYDROCHLORIDE Boxed Warning

WARNING FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue moexipril hydrochloride tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity...

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AZOR
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BENAZEPRIL HYDROCHLORIDE
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Shared indications:
Hypertension
BENICAR
OLMESARTAN MEDOXOMIL
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Shared indications:
Hypertension
BENICAR HCT
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Shared indications:
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BISOPROLOL FUMARATE
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Shared indications:
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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MOEXIPRIL HYDROCHLORIDE FDA Label Details

Pro

Indications & Usage

Moexipril hydrochloride tablets are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets do not have a similar risk (see WARNINGS ). In considering use of moexipril hydrochloride tablets, it should be noted that in controlled tri...

⚠️ BOXED WARNING

WARNING FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue moexipril hydrochloride tablets as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: F...

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Data Sources

FDA Approval: ANDA090416 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.