Olopatadine Hydrochloride
NDC Package 61314-320-01

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 Sandoz Inc, this product is identified by NDC 61314-320 and is authorized under FDA application NDA021861.

Identification & Billing

NDC Package Code
61314-320-01
Package Description
1 BOTTLE in 1 CARTON / 30500 uL in 1 BOTTLE
Product Code
61314-320
11-Digit Billing Format
61314032001
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.

Clinical Specifications

Proprietary Name
Olopatadine Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Sandoz Inc
FDA Application #
NDA021861
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
04-01-2015
End Marketing Date
02-29-2024
Listing Expiration
02-29-2024
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 61314-320-01 identifies a specific commercial package of 1 bottle in 1 carton / 30500 ul in 1 bottle of Olopatadine Hydrochloride, labeled by Sandoz Inc. 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 Sandoz Inc on April 01, 2015. The current certification is valid through February 29, 2024.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314032001. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
61314-320-01
11-Digit CMS (5-4-2)
61314-0320-01

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