Drugplain

Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL

Olopatadine Hydrochloride Ophthalmic · SOLUTION · Gland Pharma Limited

3 Recalls on Record
Plain English

Olopatadine hydrochloride ophthalmic solution is an antihistamine eye drop used to relieve itching caused by allergies. It is available over-the-counter and is applied directly to the eyes.

Key Facts

Brand Name
Olopatadine Hydrochloride Ophthalmic Solution
Generic Name
Olopatadine Hydrochloride Ophthalmic
NDC Code (Product)
68083-231
Manufacturer
Gland Pharma Limited
Strength
2 mg/mL
Dosage Form
SOLUTION
Route
OPHTHALMIC
Marketing Status
Application #
ANDA209752
Marketing Start
05/20/2020

Recall History

3 Recalls on Record
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class II10/09/2025

USV Private Limited

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

OngoingVoluntary: Firm initiated
Class II02/23/2023

Teva Pharmaceuticals USA Inc

Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

treatment failure1,933 reports
drug ineffective230 reports
nausea115 reports
headache112 reports
diarrhoea111 reports
pyrexia102 reports
fatigue101 reports
pneumonia100 reports
malaise97 reports
rash88 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

Dosage & Administration

Directions adults and children 2 years of age and older: put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day if using other ophthalmic products while using this product, wait at least 5 minutes between each product replace cap after each use children under 2 years of age: consult a doctor

Warnings

Warnings For external use only

Frequently Asked Questions

What is Olopatadine Hydrochloride Ophthalmic Solution used for?

Olopatadine hydrochloride ophthalmic solution is an antihistamine eye drop used to relieve itching caused by allergies. It is available over-the-counter and is applied directly to the eyes.

Is Olopatadine Hydrochloride Ophthalmic Solution a controlled substance?

Olopatadine Hydrochloride Ophthalmic Solution is not classified as a controlled substance by the DEA.

What is the generic name for Olopatadine Hydrochloride Ophthalmic Solution?

The generic name for Olopatadine Hydrochloride Ophthalmic Solution is Olopatadine Hydrochloride Ophthalmic. There are 5 other brand versions of Olopatadine Hydrochloride Ophthalmic.

What is the NDC code for Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL?

The NDC (National Drug Code) for Olopatadine Hydrochloride Ophthalmic Solution 2 mg/mL is 68083-231, listed by Gland Pharma Limited.

Product NDC

68083-231

Package NDC

68083-231-01

Other Olopatadine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)