Olopatadine Hydrochloride Ophthalmic Solution 7 mg/mL

olopatadine hydrochloride · SOLUTION/ DROPS · Dr. Reddy's Laboratories Inc.

3 Recalls on Record

Plain English

Olopatadine Hydrochloride Ophthalmic Solution is a solution/ drops containing olopatadine hydrochloride at 7 mg/mL, taken ophthalmic. Manufactured by Dr. Reddy's Laboratories Inc..

Key Facts

Brand Name: Olopatadine Hydrochloride Ophthalmic Solution
Generic Name: olopatadine hydrochloride
NDC Code (Product): 75907-285
Manufacturer: Dr. Reddy's Laboratories Inc.
Strength: 7 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: ANDA213514
Marketing Start: 04/15/2026

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. 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. There are 9 other brand versions of olopatadine hydrochloride.

What is the NDC code for Olopatadine Hydrochloride Ophthalmic Solution 7 mg/mL?

The NDC (National Drug Code) for Olopatadine Hydrochloride Ophthalmic Solution 7 mg/mL is 75907-285, listed by Dr. Reddy's Laboratories Inc..

Product NDC

75907-285

Package NDC

75907-285-02

Other Olopatadine Brands

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

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