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Promethazine

Generic Name
Promethazine
Brand Names
Phenadoz, Phenergan, Promethazine DM, Promethegan
Drug Type
Small Molecule
Chemical Formula
C17H20N2S
CAS Number
60-87-7
Unique Ingredient Identifier
FF28EJQ494

Overview

Promethazine, originally known as 3,277 R.P., is an N-dimethylaminopropyl derivative of phenothiazine that was developed in France in 1946. Promethazine antagonizes a variety of receptors, allowing it to be used for a number of indications including allergic reactions, pain, sedation, nausea, and vomiting. Promethazine was granted FDA approval before 29 March 1951.

Background

Promethazine, originally known as 3,277 R.P., is an N-dimethylaminopropyl derivative of phenothiazine that was developed in France in 1946. Promethazine antagonizes a variety of receptors, allowing it to be used for a number of indications including allergic reactions, pain, sedation, nausea, and vomiting. Promethazine was granted FDA approval before 29 March 1951.

Indication

Promethazine tablets and suppositories are indicated to treat rhinitis, allergic conjunctivitis, allergic reactions to blood or plasma, dermographism, anaphylactic reactions, sedation, nausea, vomiting, pain, motion sickness, and allergic skin reactions. Promethazine cough syrup with phenylephrine and codeine is indicated to relieve cough and upper respiratory symptoms, and nasal congestion associated with allergy or the common cold.

Associated Conditions

  • Allergic Conjunctivitis (AC)
  • Allergic urticaria
  • Anaphylaxis
  • Cough
  • Dermographism
  • Motion Sickness
  • Nasal Congestion
  • Postoperative pain
  • Seasonal Allergic Rhinitis
  • Vasomotor Rhinitis
  • Acute Allergic Reactions
  • Dry cough
  • Perioperative nausea and vomiting
  • Upper respiratory symptoms

FDA Approved Products

PROMETHAZINE HYDROCHLORIDE
Manufacturer:PD-Rx Pharmaceuticals, Inc.
Route:ORAL
Strength:25 mg in 1 1
Approved: 2024/02/07
NDC:43063-874
PROMETHAZINE HYDROCHLORIDE
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:25 mg in 1 1
Approved: 2020/11/09
NDC:50090-4750
Promethazine with Codeine
Manufacturer:ATLANTIC BIOLOGICALS CORP.
Route:ORAL
Strength:6.25 mg in 5 mL
Approved: 2021/01/25
NDC:17856-0605
Promethazine Hydrochloride
Manufacturer:Blenheim Pharmacal, Inc.
Route:ORAL
Strength:12.5 mg in 1 1
Approved: 2015/08/28
NDC:10544-512
PROMETHAZINE HYDROCHLORIDE
Manufacturer:Northwind Pharmaceuticals
Route:ORAL
Strength:25 mg in 1 1
Approved: 2023/01/01
NDC:51655-462

Singapore Approved Products

XEPAGAN ELIXIR 10 mg/5 ml
Manufacturer:XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
Form:ELIXIR
Strength:10 mg/5 ml
Online:Yes
Approved: 1989/06/07
Approval:SIN03294P
DBL PROMETHAZINE HYDROCHLORIDE INJECTION BP 50 mg/2 ml
Manufacturer:Siegfried Hameln GmbH
Form:INJECTION
Strength:50 mg
Online:Yes
Approved: 1989/05/03
Approval:SIN02707P
PROZINE SYRUP 5 mg/5 ml
Manufacturer:SUNWARD PHARMACEUTICAL PRIVATE LIMITED
Form:SYRUP
Strength:5 mg/5 ml
Online:Yes
Approved: 1989/03/06
Approval:SIN02481P
PROMETHAZINE 5 MG SYRUP 5 mg/5 ml
Manufacturer:BEACONS PHARMACEUTICALS PTE LTD
Form:SYRUP
Strength:5 mg/5 ml
Online:Yes
Approved: 1998/10/28
Approval:SIN10327P
PROMAGEN 10 ORAL MIXTURE 10 mg/5 ml
Manufacturer:ICM PHARMA PTE. LTD.
Form:SYRUP
Strength:10 mg/5 ml
Online:Yes
Approved: 1996/12/14
Approval:SIN09073P

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