NDAORALTABLET
Approved
Apr 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
NORMOZIDE (hydrochlorothiazide; labetalol hydrochloride) by Merck & Co. is mechanism of action lisinopril inhibits angiotensin-converting enzyme (ace) in human subjects and animals. Approved for hypertension. First approved in 1987.
Drug data last refreshed 16h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NORMOZIDE is a fixed-dose combination of hydrochlorothiazide (a thiazide diuretic) and labetalol hydrochloride (a combined alpha/beta-adrenergic blocker) approved in 1987 for hypertension management. The product works through dual mechanisms: labetalol reduces sympathetic outflow and peripheral vascular resistance, while hydrochlorothiazide promotes sodium and water excretion to lower blood volume and pressure. This combination addresses hypertension across multiple pathways, making it effective for patients requiring dual antihypertensive therapy.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team focus likely shifting toward lifecycle management, cost containment, and preparation for generic transition.
Mechanism of Action
Mechanism of Action Lisinopril inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the…
Indications (1)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.