Home NDC 82584-701 iVIZIA Lubricant Eye Gel
Product NDC 82584-701
11-digit product format 825840701
Labeler code 82584
Product ID 82584-701_509e6e7c-bb53-f135-e063-6294a90a5279
Type HUMAN OTC DRUG
Nonproprietary name povidone
Dosage form GEL
Route OPHTHALMIC
Labeler Thea Pharma Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance POVIDONE, UNSPECIFIED
Active strength 2.5 mg/.5g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base iVIZIA Lubricant Eye Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE, UNSPECIFIED 2.5 mg/.5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination FZ989GH94E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2623245 Internal RxNorm lookup 2623248 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82584-701-12 iVIZIA Lubricant Eye Gel 30 in 1 CARTON GEL 30 3 82584-701-12 iVIZIA Lubricant Eye Gel 0.4 g in 1 VIAL, SINGLE-USE GEL 0.4 3 82584-701-60 iVIZIA Lubricant Eye Gel 0.4 g in 1 VIAL, SINGLE-USE GEL 0.4 3 82584-701-60 iVIZIA Lubricant Eye Gel 30 in 1 CARTON GEL 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82584-701 IVIZIA LUBRICANT EYE GEL (POVIDONE) GEL [THEA PHARMA INC.] 1 Current NDC, 4 package rows 20241202_1f06ca1a-5270-9a82-e063-6294a90aed64.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82584-701-12 82584070112 30 VIAL, SINGLE-USE in 1 CARTON (82584-701-12) / .4 g in 1 VIAL, SINGLE-USE 2024-12-01 No No Current 82584-701-60 82584070160 30 VIAL, SINGLE-USE in 1 CARTON (82584-701-60) / .4 g in 1 VIAL, SINGLE-USE 2026-04-30 Yes No Current