NDAORALSYRUP
Approved
Apr 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMBENYL is a fixed-dose oral syrup combining bromodiphenhydramine hydrochloride (antihistamine) and codeine phosphate (opioid cough suppressant), approved in 1954. The product is indicated for cough and cold symptoms, with the antihistamine providing anticholinergic and sedative effects while codeine provides antitussive action. This combination targets patients seeking symptom relief from upper respiratory conditions.
LOE Approaching
As a legacy product approaching loss of exclusivity, AMBENYL faces modest team investment with focus on managed decline and transition planning rather than growth initiatives.
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
AMBENYL offers minimal career growth opportunity, with zero linked job openings reflecting its legacy status and approaching exclusivity loss. Career value lies in managing a mature portfolio asset, handling regulatory compliance, and navigating product discontinuation—useful for operations and risk-management professionals but not for those seeking innovation or commercial expansion.
Product Manager
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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.