Olopatadine Hydrochloride
NDC Package 68083-230-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Olopatadine Hydrochloride is a . Marketed by Gland Pharma Limited, this product is identified by NDC 68083-230 and is authorized under FDA application ANDA209619.

Identification & Billing

NDC Package Code
68083-230-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
Product Code
68083-230
11-Digit Billing Format
68083023001

Clinical Specifications

Proprietary Name
Olopatadine Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Gland Pharma Limited
FDA Application #
ANDA209619
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2017
End Marketing Date
08-19-2020
Listing Expiration
08-19-2020
Exclude Flag
D
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 68083-230-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic of Olopatadine Hydrochloride, labeled by Gland Pharma Limited. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Gland Pharma Limited on February 14, 2017. The current certification is valid through August 19, 2020.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083023001. 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)
68083-230-01
11-Digit CMS (5-4-2)
68083-0230-01

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