Drugplain

olopatadine hydrochloride 665 ug/1

Olopatadine Hydrochloride · SPRAY · Padagis Israel Pharmaceuticals Ltd

4 Recalls on Record
Plain English

olopatadine hydrochloride is a spray containing olopatadine hydrochloride at 665 ug/1, taken nasal. Manufactured by Padagis Israel Pharmaceuticals Ltd.

Key Facts

Brand Name
olopatadine hydrochloride
Generic Name
Olopatadine Hydrochloride
NDC Code (Product)
45802-104
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Strength
665 ug/1
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
ANDA202853
Marketing Start
06/14/2017

Recall History

4 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 II09/24/2024

Glenmark Pharmaceuticals Inc., USA

Defective Delivery System: The dip tube is clogged causing the spray not to work.

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

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 used for?

olopatadine hydrochloride contains Olopatadine Hydrochloride. It is a spray taken nasal. Consult your doctor for specific uses.

Is olopatadine hydrochloride a controlled substance?

olopatadine hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for olopatadine hydrochloride?

The generic name for olopatadine hydrochloride is Olopatadine Hydrochloride. There are 11 other brand versions of Olopatadine Hydrochloride.

What is the NDC code for olopatadine hydrochloride 665 ug/1?

The NDC (National Drug Code) for olopatadine hydrochloride 665 ug/1 is 45802-104, listed by Padagis Israel Pharmaceuticals Ltd.