Olopatadine Hydrochloride Ophthalmic Solution
NDC Package 68083-231-01

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

Package Information

Olopatadine Hydrochloride Ophthalmic Solution (olopatadine hydrochloride ophthalmic) solution is classified as a

administered via ophthalmic route. This formulation utilizes a solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-231 and is authorized under FDA application ANDA209752.

Identification & Billing

NDC Package Code
68083-231-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC
Product Code
68083-231
11-Digit Billing Format
68083023101

Clinical Specifications

Proprietary Name
Olopatadine Hydrochloride Ophthalmic Solution
Non-Proprietary Name
Olopatadine Hydrochloride Ophthalmic
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)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
Product Type
Human Otc Drug
FDA Application #
ANDA209752
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-20-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68083-231). Click a package code to view its specific billing and regulatory data.

68083-231-85
1000 BOTTLE, PLASTIC in 1 CASE / 2.5 mL in 1 BOTTLE, PLASTIC

* 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 68083-231-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 2.5 ml in 1 bottle, plastic of Olopatadine Hydrochloride Ophthalmic Solution, a human over the counter drug labeled by Gland Pharma Limited. 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 Gland Pharma Limited on May 20, 2020. The current certification is valid through December 31, 2027.

How is this Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083023101. 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)
68083-231-01
11-Digit CMS (5-4-2)
68083-0231-01

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