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

Additional Listing Data#

Finished product
Yes
Brand name base
iVIZIA Dry Eye
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFZ989GH94E
Rxcui2570860, 2586186

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82584-700-05iVIZIA Dry Eye1 in 1 CARTONSOLUTION/ DROPS12
82584-700-05iVIZIA Dry Eye5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS52
82584-700-11iVIZIA Dry Eye10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
82584-700-11iVIZIA Dry Eye1 in 1 CARTONSOLUTION/ DROPS12
82584-700-13iVIZIA Dry Eye5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS52
82584-700-13iVIZIA Dry Eye1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82584-700-05ML - Milliliter82584-700e72c9bfe-9dc1-4a82-8492-925b0163f4d212025-05-14
82584-700-11ML - Milliliter82584-700b9d8fd91-d02b-4d9a-9400-20176eef622a12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-700IVIZIA DRY EYE (POVIDONE) SOLUTION/ DROPS [THEA PHARMA INC.]1Current NDC, 6 package rows20241202_1ef73cb1-da48-a713-e063-6294a90afa9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2586186iVIZIA 0.5 % Ophthalmic SolutionPSN1ef73cb1-da48-a713-e063-6294a90afa9d2
2570860povidone 0.5 % Ophthalmic SolutionPSN1ef73cb1-da48-a713-e063-6294a90afa9d2
2586186povidone 5 MG/ML Ophthalmic Solution [iVizia]SBD1ef73cb1-da48-a713-e063-6294a90afa9d2
2570860povidone 5 MG/ML Ophthalmic SolutionSCD1ef73cb1-da48-a713-e063-6294a90afa9d2
2586186iVizia 0.5 % Ophthalmic SolutionSY1ef73cb1-da48-a713-e063-6294a90afa9d2
2586186iVizia 5 MG/ML Ophthalmic SolutionSY1ef73cb1-da48-a713-e063-6294a90afa9d2
2570860povidone 0.5 % Ophthalmic SolutionSY1ef73cb1-da48-a713-e063-6294a90afa9d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82584-700-05825840700051 BOTTLE, DROPPER in 1 CARTON (82584-700-05) / 5 mL in 1 BOTTLE, DROPPER2024-12-01NoNoCurrent
82584-700-11825840700111 BOTTLE, DROPPER in 1 CARTON (82584-700-11) / 10 mL in 1 BOTTLE, DROPPER2024-12-01NoNoCurrent
82584-700-13825840700131 BOTTLE, DROPPER in 1 CARTON (82584-700-13) / 5 mL in 1 BOTTLE, DROPPER2024-12-01YesNoCurrent