Omlonti

Product NDC: 65086-002
Requested package NDC: 65086-002-05
11-digit product format: 650860002
Labeler code: 65086
Product ID: 65086-002_e9ecbd7e-ef67-5759-e053-2995a90ab5ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omidenepag isopropyl
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Santen Incorporated
Application: NDA215092
Marketing category: NDA
Marketing start: 2022-09-23
Marketing end: 0000-00-00
Substance: OMIDENEPAG ISOPROPYL
Active strength: 0 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65086-002	65086-002-05	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215092-001	NCE	2027-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	NCE	2027-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215092-001	NCE	2027-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215092-001	NCE	2027-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215092-001	NCE	2027-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215092-001	NCE	2027-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215092-001	NCE	2027-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215092-001	NCE	2027-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215092-001	NCE	2027-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215092-001	NCE	2027-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215092-001	NCE	2027-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215092-001	NCE	2027-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215092-001	NCE	2027-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215092-001	NCE	2027-09-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215092-001	NCE	2027-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215092-001	NCE	2027-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215092-001	NCE	2027-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215092-001	NCE	2027-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215092-001	NCE	2027-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215092-001	NCE	2027-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215092-001	NCE	2027-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215092-001	NCE	2027-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215092-001	NCE	2027-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215092-001	NCE	2027-09-22	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215092-001	NCE	2027-09-22	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75458776-82fe-4514-8132-85d10381a314	Product name	1	20230905

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
65086-002-01	2025-11-04	These highlights do not include all the information needed to use OMLONTI ® safely and effectively. See full prescribing information for OMLONTI ® . OMLONTI ® (omidenepag isopropyl ophthalmic solution) 0.002%, for topical ophthalmic use Initial U.S. Approval: 2022
65086-002-05	2025-11-04	These highlights do not include all the information needed to use OMLONTI ® safely and effectively. See full prescribing information for OMLONTI ® . OMLONTI ® (omidenepag isopropyl ophthalmic solution) 0.002%, for topical ophthalmic use Initial U.S. Approval: 2022
65086-002-01	2025-01-30	These highlights do not include all the information needed to use OMLONTI ® safely and effectively. See full prescribing information for OMLONTI ® . OMLONTI ® (omidenepag isopropyl ophthalmic solution) 0.002%, for topical ophthalmic use Initial U.S. Approval: 2022
65086-002-05	2025-01-30	These highlights do not include all the information needed to use OMLONTI ® safely and effectively. See full prescribing information for OMLONTI ® . OMLONTI ® (omidenepag isopropyl ophthalmic solution) 0.002%, for topical ophthalmic use Initial U.S. Approval: 2022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65086-002-05	ML - Milliliter	65086-002	e97c44fb-0f51-4290-95d1-043ad6bb2a5f	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65086-002	OMLONTI (OMIDENEPAG ISOPROPYL) SOLUTION/ DROPS [SANTEN INCORPORATED]	11	Legacy NDC	20231010_8e440b2c-fbe5-4c86-b7f3-3da00a5b2924.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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G0G0H52U6K	OMIDENEPAG ISOPROPYL	1187451-19-9	OMIDENEPAG ISOPROPYL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65086-002-05	65086000205	1 BOTTLE, PLASTIC in 1 CARTON (65086-002-05) > 2.5 mL in 1 BOTTLE, PLASTIC	2022-09-23	0000-00-00	No	No	Current