NDC Package 82584-701-12 Ivizia Lubricant Eye Gel

Povidone Gel Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
82584-701-12
Package Description:
30 VIAL, SINGLE-USE in 1 CARTON / .4 g in 1 VIAL, SINGLE-USE
Product Code:
Proprietary Name:
Ivizia Lubricant Eye Gel
Non-Proprietary Name:
Povidone
Substance Name:
Povidone, Unspecified
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.
11-Digit NDC Billing Format:
82584070112
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Thea Pharma Inc.
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(s):
Ophthalmic - Administration to the external eye.
Sample Package:
No
FDA Application Number:
M018
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
12-01-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 82584-701-12?

The NDC Packaged Code 82584-701-12 is assigned to a 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.. The product's dosage form is gel and is administered via ophthalmic form.

Is NDC 82584-701 included in the NDC Directory?

Yes, Ivizia Lubricant Eye Gel with product code 82584-701 is active and included in the NDC Directory. The product was first marketed by Thea Pharma Inc. on December 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 82584-701-12?

The 11-digit format is 82584070112. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-282584-701-125-4-282584-0701-12