PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
LOE Approachingpromethazine hydrochloride and dextromethorphan hydrobromide
NDAORALSYRUP
Approved
Dec 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (promethazine hydrochloride and dextromethorphan hydrobromide) by ANI Pharmaceuticals is clinical pharmacology promethazine promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. First approved in 1957.
Drug data last refreshed 1m ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
A fixed-dose combination oral syrup containing promethazine hydrochloride (an H1 receptor antagonist with antihistaminic, sedative, and antiemetic properties) and dextromethorphan hydrobromide (a non-narcotic antitussive agent). This combination treats cough and upper respiratory symptoms by suppressing the cough reflex while providing sedation and allergy relief. The product leverages promethazine's rapid onset (20 minutes) and dextromethorphan's codeine-equivalent cough suppression without addictive potential.
LOE Approaching
Product is in LOE-approaching phase with moderate competitive pressure (30%), indicating mature market status with limited growth opportunities and likely smaller brand team headcount.
Mechanism of Action
CLINICAL PHARMACOLOGY PROMETHAZINE Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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