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 7h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NORMOZIDE is a fixed-dose oral combination of hydrochlorothiazide (thiazide diuretic) and labetalol hydrochloride (combined alpha/beta blocker) approved for hypertension management. The product combines two complementary mechanisms: labetalol reduces blood pressure through alpha and beta adrenergic blockade, while hydrochlorothiazide enhances efficacy through diuresis and sodium/chloride excretion. This dual-action approach targets both vascular resistance and fluid volume to control elevated blood pressure.
LOE Approaching
Product approaching loss of exclusivity with generic competition intensifying; brand team likely focused on managed decline and cost optimization rather than growth initiatives.
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.