Ivizia Lubricant Eye Gel
NDC Package 82584-701-60

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

Ivizia Lubricant Eye Gel (povidone) gel is • Wash hands well before use. This formulation utilizes a gel delivery system. Marketed by Thea Pharma Inc., this product is identified by NDC 82584-701 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
82584-701-60
Package Description
30 VIAL, SINGLE-USE in 1 CARTON / .4 g in 1 VIAL, SINGLE-USE
Product Code
82584-701
11-Digit Billing Format
82584070160
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ivizia Lubricant Eye Gel
Non-Proprietary Name
Povidone
Substance Name
Povidone, Unspecified
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
POVIDONE, UNSPECIFIED 2.5 mg/.5g
Usage Information
• Wash hands well before use. • Take one single-use vial off the strip. Turn upside down, tap the vial and twist off the top. • Instill 1 or 2 drops in the affected eye(s) as needed. Gel is particularly suited for severe dry eye or nighttime use. • Wait at least 15 minutes between using two different eye products. Use this gel last. If you wear contact lenses: you must remove them before using iVIZIA gel. After use wait at least 30 minutes before putting your lenses back in.

Regulatory & Marketing

Labeler Name
Thea Pharma Inc.
Product Type
Human Otc Drug
FDA Application #
M018
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2024
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (82584-701). Click a package code to view its specific billing and regulatory data.

82584-701-12
30 VIAL, SINGLE-USE in 1 CARTON / .4 g in 1 VIAL, SINGLE-USE

* 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 82584-701-60 identifies a specific commercial package of 30 vial, single-use in 1 carton / .4 g in 1 vial, single-use of Ivizia Lubricant Eye Gel, a human over the counter drug labeled by Thea Pharma Inc.. This gel is formulated for ophthalmic use and contains povidone, unspecified 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 Thea Pharma Inc. on December 01, 2024. The current certification is valid through December 31, 2027.

How is this Thea Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82584070160. 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)
82584-701-60
11-Digit CMS (5-4-2)
82584-0701-60

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