Olopatadine Hydrochloride Ophthalmic Solution
NDC Package 0363-0867-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Olopatadine Hydrochloride Ophthalmic Solution solution is 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 dayif using other ophthalmic products while using this product, wait at least 5 minutes between each productreplace cap after each usechildren under 2 years of age:consult a doctor Other Informationonly for use in the eyestore between 4-25 °C (39-77 °F)protect from light. This formulation utilizes a solution delivery system. Marketed by Walgreen Company, this product is identified by NDC 0363-0867 and is authorized under FDA application ANDA206046.

Identification & Billing

NDC Package Code
0363-0867-01
Package Description
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code
0363-0867
11-Digit Billing Format
00363086701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Olopatadine Hydrochloride Ophthalmic Solution
Non-Proprietary Name
Olopatadine Hydrochloride Ophthalmic Solution
Substance Name
Olopatadine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
OLOPATADINE HYDROCHLORIDE 1 mg/mL
Pharmacologic Class
Usage Information
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 dayif using other ophthalmic products while using this product, wait at least 5 minutes between each productreplace cap after each usechildren under 2 years of age:consult a doctor Other Informationonly for use in the eyestore between 4-25 °C (39-77 °F)protect from light

Regulatory & Marketing

Labeler Name
Walgreen Company
Product Type
Human Otc Drug
FDA Application #
ANDA206046
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-22-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0363-0867-01 identifies a specific commercial package of 1 bottle in 1 carton / 5 ml in 1 bottle of Olopatadine Hydrochloride Ophthalmic Solution, a human over the counter drug labeled by Walgreen Company. This solution is formulated for ophthalmic use and contains olopatadine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Walgreen Company on December 22, 2025. The current certification is valid through December 31, 2026.

How is this Walgreen Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363086701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0363-0867-01
11-Digit CMS (5-4-2)
00363-0867-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.