Home NDC 84826-002 Omlonti
Product NDC 84826-002
11-digit product format 848260002
Labeler code 84826
Product ID 84826-002_33504c5f-664b-4f6b-e063-6294a90a2aea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omidenepag isopropyl
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Ocuvex Therapeutics, Inc.
Application NDA215092
Marketing category NDA
Marketing start 2022-09-23
Substance OMIDENEPAG ISOPROPYL
Active strength .02 mg/mL
Pharmacologic classes Prostaglandin E2 Receptor Agonist [EPC], Prostaglandin E2 Receptor Agonists [MoA]
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 1 .
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 N215092-001 OMLONTI OMIDENEPAG ISOPROPYL 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215092-001 8648097 2029-10-13 Drug substance, Drug product 2022-10-20 N215092-001 8685986 2029-10-13 Drug product 2022-10-20 N215092-001 10179127 2035-01-08 U-3454 Drug product 2022-10-20 N215092-001 10702511 2035-01-08 U-3454 Drug product 2022-10-20 N215092-001 10765750 2035-01-08 Drug product 2022-10-20 N215092-001 11197849 2035-01-08 U-3454 Drug product 2022-10-20 N215092-001 11793798 2035-01-08 U-3454 Drug product 2023-11-09 N215092-001 12295946 2035-01-08 U-3454 Drug product 2025-07-21 N215092-001 9415038 2035-01-08 U-3454 Drug product 2022-10-20 N215092-001 RE48183 2035-01-08 U-3454 Drug product 2022-10-20 N215092-001 10774072 2035-06-10 Drug substance 2022-10-20 N215092-001 12290511 2038-12-27 U-3454 2025-07-21 N215092-001 11666563 2039-07-16 U-3454 2023-06-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215092-001 NCE 2027-09-22
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 2026-02-19 14:30 UTC 2026-02 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD 2022-09-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215092-001 OMLONTI 0.002% SOLUTION / OPHTHALMIC RLD, RS 2022-09-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 272 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215092-001 8648097 2029-10-13 Drug substance, Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 8685986 2029-10-13 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 10179127 2035-01-08 U-3454 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 10702511 2035-01-08 U-3454 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 10765750 2035-01-08 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 11197849 2035-01-08 U-3454 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 11793798 2035-01-08 U-3454 Drug product 2023-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 12295946 2035-01-08 U-3454 Drug product 2025-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 9415038 2035-01-08 U-3454 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 RE48183 2035-01-08 U-3454 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 10774072 2035-06-10 Drug substance 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 12290511 2038-12-27 U-3454 2025-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215092-001 11666563 2039-07-16 U-3454 2023-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 8648097 2029-10-13 Drug substance, Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 8685986 2029-10-13 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 10179127 2035-01-08 U-3454 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 10702511 2035-01-08 U-3454 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 10765750 2035-01-08 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 11197849 2035-01-08 U-3454 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 11793798 2035-01-08 U-3454 Drug product 2023-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 12295946 2035-01-08 U-3454 Drug product 2025-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 9415038 2035-01-08 U-3454 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 RE48183 2035-01-08 U-3454 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 10774072 2035-06-10 Drug substance 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 12290511 2038-12-27 U-3454 2025-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215092-001 11666563 2039-07-16 U-3454 2023-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215092-001 8648097 2029-10-13 Drug substance, Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 8685986 2029-10-13 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 10179127 2035-01-08 U-3454 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 10702511 2035-01-08 U-3454 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 10765750 2035-01-08 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 11197849 2035-01-08 U-3454 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 11793798 2035-01-08 U-3454 Drug product 2023-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 12295946 2035-01-08 U-3454 Drug product 2025-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 9415038 2035-01-08 U-3454 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 RE48183 2035-01-08 U-3454 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 10774072 2035-06-10 Drug substance 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 12290511 2038-12-27 U-3454 2025-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215092-001 11666563 2039-07-16 U-3454 2023-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215092-001 8648097 2029-10-13 Drug substance, Drug product 2022-10-20 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Omlonti
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMIDENEPAG ISOPROPYL .02 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G0G0H52U6K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2612702 Internal RxNorm lookup 2612704 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 84826-002-01 Omlonti 1 in 1 CARTON SOLUTION/ DROPS 1 3 84826-002-01 Omlonti 2.5 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 2.5 3 84826-002-03 Omlonti 2.5 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 2.5 3 84826-002-03 Omlonti 3 in 1 CARTON SOLUTION/ DROPS 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84826-002 OMLONTI (OMIDENEPAG ISOPROPYL) SOLUTION/ DROPS [OCUVEX THERAPEUTICS, INC.] 3 Current NDC, 4 package rows 20250423_4258e437-7e92-4b09-baf1-01cb158cfc05.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 Omlonti OMIDENEPAG ISOPROPYL Ocuvex Therapeutics, Inc. 4258e437-7e92-4b09-baf1-01cb158cfc05 2025-04-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 215092 application number: NDA215092 ndc (product): 84826-002
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84826-002-01 84826000201 1 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC 2025-04-28 No No Current 84826-002-03 84826000203 3 BOTTLE, PLASTIC in 1 CARTON (84826-002-03) / 2.5 mL in 1 BOTTLE, PLASTIC 2025-04-28 No No Current