omidria

Generic: phenylephrine and ketorolac

Labeler: rayner surgical inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name omidria
Generic Name phenylephrine and ketorolac
Labeler rayner surgical inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAOCULAR
Active Ingredients

ketorolac 2.88 mg/mL, phenylephrine 10.16 mg/mL

Manufacturer
Rayner Surgical Inc.

Identifiers & Regulatory

Product NDC 82604-600
Product ID 82604-600_ffe62883-85a4-6e94-e053-6294a90ac61f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205388
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc] cyclooxygenase inhibitor [epc] alpha-1 adrenergic agonist [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa] adrenergic alpha1-agonists [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82604600
Hyphenated Format 82604-600

Supplemental Identifiers

RxCUI
1540230 1540235
UNII
YZI5105V0L 1WS297W6MV
NUI
N0000000160 M0001335 N0000175722 N0000175939 N0000186105 N0000009917

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omidria (source: ndc)
Generic Name phenylephrine and ketorolac (source: ndc)
Application Number NDA205388 (source: ndc)
Routes
INTRAOCULAR
source: ndc

Resolved Composition

Strengths
  • 2.88 mg/mL
  • 10.16 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL
  • 4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL
  • 4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL
source: ndc

Packages (3)

82604-600-00 1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL 82604-600-04 4 VIAL in 1 CARTON (82604-600-04) / 4 mL in 1 VIAL 82604-600-99 4 VIAL in 1 CARTON (82604-600-99) / 4 mL in 1 VIAL

Ingredients (2)

ketorolac (2.88 mg/mL) phenylephrine (10.16 mg/mL)

Linked Drug Pages (1)

Omidria ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAOCULAR"], "spl_id": "ffe62883-85a4-6e94-e053-6294a90ac61f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722", "N0000175939", "N0000186105", "N0000009917"], "unii": ["YZI5105V0L", "1WS297W6MV"], "rxcui": ["1540230", "1540235"], "spl_set_id": ["f25d7a42-da2a-7310-e053-2995a90a590f"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Cyclooxygenase Inhibitor [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]", "Adrenergic alpha1-Agonists [MoA]"], "manufacturer_name": ["Rayner Surgical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (82604-600-00)  / 4 mL in 1 VIAL", "package_ndc": "82604-600-00", "marketing_start_date": "20230701"}, {"sample": false, "description": "4 VIAL in 1 CARTON (82604-600-04)  / 4 mL in 1 VIAL", "package_ndc": "82604-600-04", "marketing_start_date": "20230701"}, {"sample": true, "description": "4 VIAL in 1 CARTON (82604-600-99)  / 4 mL in 1 VIAL", "package_ndc": "82604-600-99", "marketing_start_date": "20230701"}], "brand_name": "Omidria", "product_id": "82604-600_ffe62883-85a4-6e94-e053-6294a90ac61f", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["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]"], "product_ndc": "82604-600", "generic_name": "phenylephrine and ketorolac", "labeler_name": "Rayner Surgical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omidria", "active_ingredients": [{"name": "KETOROLAC", "strength": "2.88 mg/mL"}, {"name": "PHENYLEPHRINE", "strength": "10.16 mg/mL"}], "application_number": "NDA205388", "marketing_category": "NDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}