FDA.reportPublic FDA data

Omidria

Product NDC
82604-600
11-digit product format
826040600
Labeler code
82604
Product ID
82604-600_ffe62883-85a4-6e94-e053-6294a90ac61f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenylephrine and ketorolac
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAOCULAR
Labeler
Rayner Surgical Inc.
Application
NDA205388
Marketing category
NDA
Marketing start
2023-07-01
Substance
KETOROLAC; PHENYLEPHRINE
Active strength
2.88; 10.16 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE2.88 mg/mL
KETOROLAC10.16 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1WS297W6MV, YZI5105V0L
Rxcui1540230, 1540235

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82604-600-00Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE42
82604-600-00Omidria1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE12
82604-600-04Omidria4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE42
82604-600-04Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE42
82604-600-99Omidria4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE42
82604-600-99Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82604-600OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [RAYNER SURGICAL INC.]2Current NDC, 6 package rows20230708_f25d7a42-da2a-7310-e053-2995a90a590f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1540235OMIDRIA 1 % / 0.3 % Concentrate for Ophthalmic Irrigation SolutionPSNf25d7a42-da2a-7310-e053-2995a90a590f2
1540230phenylephrine 1 % / ketorolac 0.3 % Concentrate for Ophthalmic Irrigation SolutionPSNf25d7a42-da2a-7310-e053-2995a90a590f2
1540235ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]SBDf25d7a42-da2a-7310-e053-2995a90a590f2
1540230ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation SolutionSCDf25d7a42-da2a-7310-e053-2995a90a590f2
1540230ketorolac 0.3 % / phenylephrine 1 % Concentrate for Ophthalmic Irrigation SolutionSYf25d7a42-da2a-7310-e053-2995a90a590f2
1540235Omidria (ketorolac 0.3 % / phenylephrine 1 % ) Concentrate for Ophthalmic Irrigation SolutionSYf25d7a42-da2a-7310-e053-2995a90a590f2
1540235Omidria (ketorolac tromethamine 4.24 mg/ml (ketorolac 2.88 MG/ML)) / phenylephrine HCl 12.4 mg/ml (phenylephrine 10.16 MG/ML) Concentrate for Ophthalmic Irrigation SolutionSYf25d7a42-da2a-7310-e053-2995a90a590f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82604-600-00826040600001 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL1 vial2023-07-01NoNoHistorical
82604-600-04826040600044 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL4 vial2023-07-01NoNoHistorical
82604-600-99826040600994 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL4 vial2023-07-01YesNoHistorical