Omlonti

Product NDC: 65086-002
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

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65086-002-01	2025-11-04	C162847	48780-1	2cef2736-5f01-d83d-e063-dadaa90ab31f	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	C162847	48780-1	2cef2736-5f01-d83d-e063-dadaa90ab31f	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	C162847	48780-1	2cef2736-5f01-d83d-e063-dadaa90ab31f	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	C162847	48780-1	2cef2736-5f01-d83d-e063-dadaa90ab31f	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

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