IYUZEH

Product NDC
82584-003
11-digit product format
825840003
Labeler code
82584
Product ID
82584-003_1e77daf5-a752-172c-e063-6394a90a8a4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Latanoprost Ophthalmic Solution 0.005%
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Thea Pharma Inc.
Application
NDA216472
Marketing category
NDA
Marketing start
2023-07-14
Substance
LATANOPROST
Active strength
50 ug/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IYUZEH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LATANOPROST50 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6Z5B6HVF6O
Rxcui314072, 2642284

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d59b88b-5059-46d6-8e48-d5d9371caa10Product name220260211
f6b0b05b-3bf2-088a-8ccc-e1cf01a91e86Product name420250729
de829a7d-0b51-4e4d-a051-6a6568f15688Product name120230919
203382e3-d801-4f70-866f-ebe316583560Product name120190624
e516be5e-351f-4b2e-a26b-fdff13181605Product name120181220
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
82584-003-30IYUZEH30 in 1 CARTONSOLUTION/ DROPS307
82584-003-30IYUZEH0.2 mL in 1 POUCHSOLUTION/ DROPS0.27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82584-003-30EA - Each82584-003e29a267f-f750-40f6-8a3b-e8d0e46ef50f12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-003IYUZEH (LATANOPROST OPHTHALMIC SOLUTION 0.005%) SOLUTION/ DROPS [THEA PHARMA INC.]7Current NDC, 2 package rows20240731_192fc081-cc38-4e83-b779-9592e060b915.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642284IYUZEH 0.005 % Ophthalmic SolutionPSN192fc081-cc38-4e83-b779-9592e060b9157
314072latanoprost 0.005 % Ophthalmic SolutionPSN192fc081-cc38-4e83-b779-9592e060b9157
2642284latanoprost 0.05 MG/ML Ophthalmic Solution [Iyuzeh]SBD192fc081-cc38-4e83-b779-9592e060b9157
314072latanoprost 0.05 MG/ML Ophthalmic SolutionSCD192fc081-cc38-4e83-b779-9592e060b9157
2642284Iyuzeh 0.005 % Ophthalmic SolutionSY192fc081-cc38-4e83-b779-9592e060b9157
314072latanoprost 0.005 % Ophthalmic SolutionSY192fc081-cc38-4e83-b779-9592e060b9157
314072latanoprost 125 MCG per 2.5 ML Ophthalmic SolutionSY192fc081-cc38-4e83-b779-9592e060b9157

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82584-003-308258400033030 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH30 pouch2023-07-14NoNoCurrent