FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
iVIZIA Lubricant Eye Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE, UNSPECIFIED2.5 mg/.5g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFZ989GH94E
Rxcui2623245, 2623248

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82584-701-12iVIZIA Lubricant Eye Gel30 in 1 CARTONGEL303
82584-701-12iVIZIA Lubricant Eye Gel0.4 g in 1 VIAL, SINGLE-USEGEL0.43
82584-701-60iVIZIA Lubricant Eye Gel0.4 g in 1 VIAL, SINGLE-USEGEL0.43
82584-701-60iVIZIA Lubricant Eye Gel30 in 1 CARTONGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-701IVIZIA LUBRICANT EYE GEL (POVIDONE) GEL [THEA PHARMA INC.]1Current NDC, 4 package rows20241202_1f06ca1a-5270-9a82-e063-6294a90aed64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2623248iVizia 0.5 % Ophthalmic GelPSN1f06ca1a-5270-9a82-e063-6294a90aed643
2623245povidone 0.5 % Ophthalmic GelPSN1f06ca1a-5270-9a82-e063-6294a90aed643
2623248povidone 0.005 MG/MG Ophthalmic Gel [iVizia]SBD1f06ca1a-5270-9a82-e063-6294a90aed643
2623245povidone 0.005 MG/MG Ophthalmic GelSCD1f06ca1a-5270-9a82-e063-6294a90aed643
2623248iVizia 0.005 MG/MG Ophthalmic GelSY1f06ca1a-5270-9a82-e063-6294a90aed643
2623248iVizia 0.5 % Ophthalmic GelSY1f06ca1a-5270-9a82-e063-6294a90aed643
2623245povidone 0.5 % Ophthalmic GelSY1f06ca1a-5270-9a82-e063-6294a90aed643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82584-701-128258407011230 VIAL, SINGLE-USE in 1 CARTON (82584-701-12) / .4 g in 1 VIAL, SINGLE-USE2024-12-01NoNoHistorical
82584-701-608258407016030 VIAL, SINGLE-USE in 1 CARTON (82584-701-60) / .4 g in 1 VIAL, SINGLE-USE2026-04-30YesNoHistorical