Saturday, July 11, 2026

Drug profile · INN

promethazine hydrochloride

promethazine hydrochloride (PROMETHAZINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: rectal. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — promethazine hydrochloride
US status
approved
Class
Route
RECTAL
Patents
0
Programs
1
Data quality
0.89

Quick answer

promethazine hydrochloride (PROMETHAZINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: rectal. Current US regulatory status: approved.

Key facts

INN promethazine hydrochloride
Brand PROMETHAZINE HYDROCHLORIDE
Mechanism Histamine H1 receptor antagonist
Target Histamine H1 receptor
Route RECTAL
Formulation SYRUP

Mechanism of action

Histamine H1 receptor antagonist

Primary target: Histamine H1 receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. TCD17197 Phase 2 · Sanofi-Aventis U.S · Acute lymphocytic leukaemia- Acute myeloid leukaemia refract

Related & competitor drugs

  1. azelastine hydrochloride Histamine H1 receptor antagonist
  2. brompheniramine maleate Histamine H1 receptor antagonist
  3. carbinoxamine maleate Histamine H1 receptor antagonist
  4. cetirizine hydrochloride Histamine H1 receptor antagonist
  5. chlorpheniramine maleate Histamine H1 receptor antagonist
  6. clemastine fumarate Histamine H1 receptor antagonist

Frequently asked questions

What is promethazine hydrochloride?

promethazine hydrochloride (PROMETHAZINE HYDROCHLORIDE) is a histamine h1 receptor antagonist. Associated with Amneal Pharma Europe Ltd. Route of administration: rectal. Current US regulatory status: approved.

What is the brand name for promethazine hydrochloride?

PROMETHAZINE HYDROCHLORIDE is a marketed brand name for promethazine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of promethazine hydrochloride?

promethazine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.