FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMIDENEPAG ISOPROPYL.02 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG0G0H52U6K
Rxcui2612702, 2612704

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75458776-82fe-4514-8132-85d10381a314Product name120230905

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84826-002-01Omlonti1 in 1 CARTONSOLUTION/ DROPS13
84826-002-01Omlonti2.5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS2.53
84826-002-03Omlonti2.5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS2.53
84826-002-03Omlonti3 in 1 CARTONSOLUTION/ DROPS33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84826-002-01ML - Milliliter84826-0020394bf31-fdc7-4df3-a2ce-64c8a3a807f712026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84826-002OMLONTI (OMIDENEPAG ISOPROPYL) SOLUTION/ DROPS [OCUVEX THERAPEUTICS, INC.]3Current NDC, 4 package rows20250423_4258e437-7e92-4b09-baf1-01cb158cfc05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2612702omidenepag isopropyl 0.002 % Ophthalmic SolutionPSN4258e437-7e92-4b09-baf1-01cb158cfc053
2612704OMLONTI 0.002 % Ophthalmic SolutionPSN4258e437-7e92-4b09-baf1-01cb158cfc053
2612704omidenepag isopropyl 0.02 MG/ML Ophthalmic Solution [Omlonti]SBD4258e437-7e92-4b09-baf1-01cb158cfc053
2612702omidenepag isopropyl 0.02 MG/ML Ophthalmic SolutionSCD4258e437-7e92-4b09-baf1-01cb158cfc053
2612702omidenepag isopropyl 0.002 % Ophthalmic SolutionSY4258e437-7e92-4b09-baf1-01cb158cfc053
2612704OMLONTI 0.002 % Ophthalmic SolutionSY4258e437-7e92-4b09-baf1-01cb158cfc053
2612704Omlonti 0.02 MG/ML Ophthalmic SolutionSY4258e437-7e92-4b09-baf1-01cb158cfc053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84826-002-01848260002011 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC2025-04-28NoNoHistorical
84826-002-03848260002033 BOTTLE, PLASTIC in 1 CARTON (84826-002-03) / 2.5 mL in 1 BOTTLE, PLASTIC2025-04-28NoNoHistorical