Ivizia Dry Eye Solution/ Drops
NDC Package 82584-700-13

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 Dry Eye (povidone) solution/ dropses is wash hands well before use. This formulation utilizes a solution/ drops delivery system. Marketed by Thea Pharma Inc., this product is identified by NDC 82584-700 and is authorized under FDA application M018.

Identification & Billing

NDC Package Code
82584-700-13
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
82584-700
11-Digit Billing Format
82584070013
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ivizia Dry Eye
Non-Proprietary Name
Povidone
Substance Name
Povidone
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
POVIDONE 25 mg/5mL
Usage Information
Wash hands well before use. Twist cap counterclockwise to break tamper evident seal. Press firmly on bottle sides. Dispensing drops is slower due to preservative-free filter. Dispense 1-2 drops in the affected eye as needed. Safe with contacts. *To limit blurriness when using contact lenses: remove contacts, apply drops, then insert contacts.

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
12-31-2026
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 (82584-700). Click a package code to view its specific billing and regulatory data.

82584-700-05
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
82584-700-11
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

* 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 82584-700-13 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Ivizia Dry Eye, a human over the counter drug labeled by Thea Pharma Inc.. This solution/ drops is formulated for ophthalmic use and contains povidone 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, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82584070013. 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)
82584-700-13
11-Digit CMS (5-4-2)
82584-0700-13

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