Drugplain

Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL

Olopatadine Hydrochloride Ophthalmic · SOLUTION/ DROPS · Chain Drug Marketing Association INC

3 Recalls on Record
Plain English

Olopatadine Hydrochloride Ophthalmic Solution is a solution/ drops containing olopatadine hydrochloride ophthalmic at 1 mg/mL, taken ophthalmic. Manufactured by Chain Drug Marketing Association INC.

Key Facts

Brand Name
Olopatadine Hydrochloride Ophthalmic Solution
Generic Name
Olopatadine Hydrochloride Ophthalmic
NDC Code (Product)
63868-822
Manufacturer
Chain Drug Marketing Association INC
Strength
1 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA209619
Marketing Start
01/01/2021

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 contains Olopatadine Hydrochloride Ophthalmic. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

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 1 mg/mL?

The NDC (National Drug Code) for Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL is 63868-822, listed by Chain Drug Marketing Association INC.

Product NDC

63868-822

Package NDC

63868-822-05

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)