Home NDC 82584-700 iVIZIA Dry Eye
Product NDC 82584-700
11-digit product format 825840700
Labeler code 82584
Product ID 82584-700_4197af7c-fb98-684b-e063-6394a90a64cf
Type HUMAN OTC DRUG
Nonproprietary name povidone
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Thea Pharma Inc.
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance POVIDONE
Active strength 25 mg/5mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Dry Eye
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POVIDONE 25 mg/5mL
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 2570860 Internal RxNorm lookup 2586186 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 82584-700-05 iVIZIA Dry Eye 1 in 1 CARTON SOLUTION/ DROPS 1 2 82584-700-05 iVIZIA Dry Eye 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 2 82584-700-11 iVIZIA Dry Eye 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 2 82584-700-11 iVIZIA Dry Eye 1 in 1 CARTON SOLUTION/ DROPS 1 2 82584-700-13 iVIZIA Dry Eye 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 2 82584-700-13 iVIZIA Dry Eye 1 in 1 CARTON SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82584-700 IVIZIA DRY EYE (POVIDONE) SOLUTION/ DROPS [THEA PHARMA INC.] 1 Current NDC, 6 package rows 20241202_1ef73cb1-da48-a713-e063-6294a90afa9d.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 82584-700-05 82584070005 1 BOTTLE, DROPPER in 1 CARTON (82584-700-05) / 5 mL in 1 BOTTLE, DROPPER 2024-12-01 No No Current 82584-700-11 82584070011 1 BOTTLE, DROPPER in 1 CARTON (82584-700-11) / 10 mL in 1 BOTTLE, DROPPER 2024-12-01 No No Current 82584-700-13 82584070013 1 BOTTLE, DROPPER in 1 CARTON (82584-700-13) / 5 mL in 1 BOTTLE, DROPPER 2024-12-01 Yes No Current