FDA.reportPublic FDA data

Omidria

Product NDC
62225-600
11-digit product format
622250600
Labeler code
62225
Product ID
62225-600_4ef3b158-3042-6a1f-e063-6394a90a807f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenylephrine and ketorolac
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAOCULAR
Labeler
Omeros Corporation
Application
NDA205388
Marketing category
NDA
Marketing start
2014-06-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omidria
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC2.88 mg/mL
PHENYLEPHRINE10.16 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYZI5105V0L, 1WS297W6MV
Rxcui1540230, 1540235

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62225-600-002025-01-30C16284748780-12cef2736-a2fb-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use OMIDRIA ® safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution Initial U.S. Approval: 2014
62225-600-042025-01-30C16284748780-12cef2736-a2fb-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use OMIDRIA ® safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution Initial U.S. Approval: 2014
62225-600-102025-01-30C16284748780-12cef2736-a2fb-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use OMIDRIA ® safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution Initial U.S. Approval: 2014
62225-600-992025-01-30C16284748780-12cef2736-a2fb-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use OMIDRIA ® safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA ® (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62225-600-00Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416
62225-600-00Omidria1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE116
62225-600-04Omidria4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE416
62225-600-04Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416
62225-600-10Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416
62225-600-10Omidria10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE1016
62225-600-99Omidria4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE416
62225-600-99Omidria4 mL in 1 VIALINJECTION, SOLUTION, CONCENTRATE416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62225-600-00ML - Milliliter62225-60037819fd5-b099-4bab-a80e-42fb4f84e3bb12015-04-03
62225-600-04ML - Milliliter62225-600001bddf6-52b1-4c56-b56a-330a903a866612015-04-03
62225-600-10ML - Milliliter62225-600bc2c4826-054a-4e8b-855a-c907258aedb712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLACACTIVE INGREDIENTYZI5105V0LOMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]11
PHENYLEPHRINEACTIVE INGREDIENT1WS297W6MVOMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]11
KETOROLACACTIVE MOIETYYZI5105V0LOMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]11
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVOMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPOMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KOMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]11
WATERINACTIVE INGREDIENT059QF0KO0ROMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62225-600OMIDRIA (PHENYLEPHRINE AND KETOROLAC) INJECTION, SOLUTION, CONCENTRATE [OMEROS CORPORATION]15Current NDC, Legacy NDC, 8 package rows20221217_21470688-4e81-4ea5-ac38-f72e10552e7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1540235OMIDRIA 1 % / 0.3 % Concentrate for Ophthalmic Irrigation SolutionPSN21470688-4e81-4ea5-ac38-f72e10552e7e16
1540230phenylephrine 1 % / ketorolac 0.3 % Concentrate for Ophthalmic Irrigation SolutionPSN21470688-4e81-4ea5-ac38-f72e10552e7e16
1540235ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]SBD21470688-4e81-4ea5-ac38-f72e10552e7e16
1540230ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation SolutionSCD21470688-4e81-4ea5-ac38-f72e10552e7e16
1540230ketorolac 0.3 % / phenylephrine 1 % Concentrate for Ophthalmic Irrigation SolutionSY21470688-4e81-4ea5-ac38-f72e10552e7e16
1540235Omidria (ketorolac 0.3 % / phenylephrine 1 % ) Concentrate for Ophthalmic Irrigation SolutionSY21470688-4e81-4ea5-ac38-f72e10552e7e16
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 SolutionSY21470688-4e81-4ea5-ac38-f72e10552e7e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62225-600-00622250600001 VIAL in 1 CARTON (62225-600-00) > 4 mL in 1 VIAL1 vial2014-06-130000-00-00NoNoCurrent
62225-600-04622250600044 VIAL in 1 CARTON (62225-600-04) > 4 mL in 1 VIAL4 vial2014-06-130000-00-00NoNoCurrent
62225-600-106222506001010 VIAL in 1 CARTON (62225-600-10) > 4 mL in 1 VIAL10 vial2014-06-130000-00-00NoNoCurrent
62225-600-99622250600994 VIAL in 1 CARTON (62225-600-99) > 4 mL in 1 VIAL4 vial2015-03-170000-00-00NoNoCurrent