Olopatadine Hydrochloride Solution
NDC Package 76162-044-39

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

Package Information

Olopatadine Hydrochloride solution is adults and children 2 years of age and older:put 1 drop in the affected eye(s) once daily, no more than once 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. This formulation utilizes a solution delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 76162-044 and is authorized under FDA application ANDA209995.

Identification & Billing

NDC Package Code
76162-044-39
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC
Product Code
76162-044
11-Digit Billing Format
76162004439
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Olopatadine Hydrochloride
Non-Proprietary Name
Olopatadine Hydrochloride
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 2 mg/mL
Pharmacologic Class
Usage Information
Adults and children 2 years of age and older:put 1 drop in the affected eye(s) once daily, no more than once 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

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA209995
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2020
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 76162-044-39 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 2.5 ml in 1 bottle, plastic of Olopatadine Hydrochloride, a human over the counter drug labeled by Topco Associates Llc. 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 Topco Associates Llc on July 15, 2020. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162004439. 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 (5-3-2)
76162-044-39
11-Digit CMS (5-4-2)
76162-0044-39

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