NDAORALTABLET
Approved
Oct 1981
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
MODURETIC 5-50 (amiloride hydrochloride; hydrochlorothiazide) by Merck & Co.. Approved for those patients with hypertension, congestive heart failure, other kaliuretic diuretics are used alone and 3 more indications. First approved in 1981.
Drug data last refreshed 12h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MODURETIC 5-50 is a fixed-dose oral combination of amiloride hydrochloride (potassium-sparing diuretic) and hydrochlorothiazide (thiazide diuretic) approved for hypertension and congestive heart failure. It works by promoting sodium and chloride excretion while amiloride blocks potassium loss, maintaining normal serum potassium levels. The combination addresses the electrolyte imbalance that occurs when thiazide diuretics are used alone.
LOE Approaching
As a legacy diuretic combination with approaching loss-of-exclusivity, the brand team is likely small and focused on defensive market maintenance and cost management rather than expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (6)
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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.