NDAORALTABLET, CHEWABLE, TABLET, CAPSULE
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
HELIDAC (bismuth subsalicylate; metronidazole; tetracycline hydrochloride) by R-Pharm US. Approved for travelers' diarrhea diarrhea upset stomach due to overindulgence in food, drink, including: heartburn indigestion nausea gas belching fullness. First approved in 1996.
Drug data last refreshed 11h ago · AI intelligence enriched 13h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HELIDAC is a fixed-dose combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride indicated for travelers' diarrhea and gastrointestinal upset including heartburn, indigestion, nausea, gas, and bloating. The combination works through bismuth's cytoprotective and antimicrobial effects, metronidazole's antiprotozoal activity, and tetracycline's broad antimicrobial spectrum to address multiple GI pathologies. This is an oral tablet formulation approved in 1996.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating a consolidating commercial team focused on generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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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.