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Apraclonidine

Generic Name
Apraclonidine
Brand Names
Iopidine
Drug Type
Small Molecule
Chemical Formula
C9H10Cl2N4
CAS Number
66711-21-5
Unique Ingredient Identifier
843CEN85DI

Overview

Apraclonidine, also known as iopidine, is a sympathomimetic used in glaucoma therapy. It is an alpha2-adrenergic agonist.

Indication

For prevention or reduction of intraoperative and postoperative increases in intraocular pressure (IOP) before and after ocular laser surgery when used prophylactically. Also used as a short-term adjunctive therapy in patients with open-angle glaucoma who are on maximally tolerated medical therapy requiring additional IOP reduction.

Associated Conditions

  • Ocular Hypertension
  • Postsurgical ocular hypertension

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Alcon Laboratories, Inc.
0065-0660
OPHTHALMIC
10 mg in 1 mL
12/21/2018
Harrow Eye, LLC
82667-200
OPHTHALMIC
10 mg in 1 mL
7/31/2023
Akorn
17478-716
OPHTHALMIC
5 mg in 1 mL
2/1/2009
Sandoz Inc
61314-665
OPHTHALMIC
5.75 mg in 1 mL
7/25/2019

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
IOPIDINE apraclonidine 5mg/mL (as hydrochloride) eye drops bottle
51190
Medicine
A
6/29/1992

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
IOPIMAX 10 mg/ml COLIRIO EN SOLUCION
61225
COLIRIO EN SOLUCIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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