Home NDC 82584-003 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216472-001 IYUZEH LATANOPROST 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216472-001 IYUZEH 0.005% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2022-12-13 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216472-001 8637054 2031-07-08 U-446 Drug product 2024-02-20 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base IYUZEH
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LATANOPROST 50 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6Z5B6HVF6O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314072 Internal RxNorm lookup 2642284 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 82584-003-30 IYUZEH 30 in 1 CARTON SOLUTION/ DROPS 30 7 82584-003-30 IYUZEH 0.2 mL in 1 POUCH SOLUTION/ DROPS 0.2 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82584-003 IYUZEH (LATANOPROST OPHTHALMIC SOLUTION 0.005%) SOLUTION/ DROPS [THEA PHARMA INC.] 7 Current NDC, 2 package rows 20240731_192fc081-cc38-4e83-b779-9592e060b915.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IYUZEH LATANOPROST OPHTHALMIC SOLUTION 0.005% Thea Pharma Inc. 192fc081-cc38-4e83-b779-9592e060b915 2024-07-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 216472 application number: NDA216472 ndc (product): 82584-003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82584-003-30 82584000330 30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH 30 pouch 2023-07-14 No No Current