NDAORALTABLET
Approved
Apr 2018
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XTRELUS is an oral combination tablet containing guaifenesin (expectorant) and hydrocodone bitartrate (opioid antitussive), approved in April 2018 for cough and respiratory symptoms. Guaifenesin thins mucus secretions while hydrocodone suppresses cough reflex via central nervous system depression. This is a Schedule II controlled substance combination product.
Peak
Product is in peak commercial phase with moderate competitive pressure (30/100), suggesting stable team headcount and established market position for a mature cough/cold remedy.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
XTRELUS offers limited direct career momentum with zero linked job openings, typical of a stable, mature branded generic in a declining cough/cold category. Roles focus on defending market share and managing DEA compliance rather than driving innovation or market expansion.
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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.