Omidria Injection, Solution, Concentrate
NDC Package 82604-600-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Omidria (phenylephrine and ketorolac) injection is omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Rayner Surgical Inc., this product is identified by NDC 82604-600 and is authorized under FDA application NDA205388.

Identification & Billing

NDC Package Code
82604-600-99
Package Description
4 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code
82604-600
11-Digit Billing Format
82604060099
RxNorm Crosswalk
  • RxCUI: 1540230 - phenylephrine 1 % / ketorolac 0.3 % Concentrate for Ophthalmic Irrigation Solution
  • RxCUI: 1540230 - ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution
  • RxCUI: 1540230 - ketorolac 0.3 % / phenylephrine 1 % Concentrate for Ophthalmic Irrigation Solution
  • RxCUI: 1540235 - OMIDRIA 1 % / 0.3 % Concentrate for Ophthalmic Irrigation Solution
  • RxCUI: 1540235 - ketorolac 2.88 MG/ML / phenylephrine 10.16 MG/ML Ophthalmic Irrigation Solution [Omidria]

Clinical Specifications

Proprietary Name
Omidria
Non-Proprietary Name
Phenylephrine And Ketorolac
Substance Name
Ketorolac; Phenylephrine
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intraocular - Administration within the eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.

Regulatory & Marketing

Labeler Name
Rayner Surgical Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA205388
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82604-600). Click a package code to view its specific billing and regulatory data.

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

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82604-600-99 identifies a specific commercial package of 4 vial in 1 carton / 4 ml in 1 vial of Omidria, a human prescription drug labeled by Rayner Surgical Inc.. This injection, solution, concentrate is formulated for intraocular use and contains ketorolac; phenylephrine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Rayner Surgical Inc. on July 01, 2023. The current certification is valid through December 31, 2026.

How is this Rayner Surgical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82604060099. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
82604-600-99
11-Digit CMS (5-4-2)
82604-0600-99

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.