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  5. NDC Package Code: 82604-600-00 Omidria

NDC Package 82604-600-00 Omidria

Phenylephrine And Ketorolac Injection, Solution, Concentrate Intraocular - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
82604-600-00
Package Description:
1 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code:
82604-600
Proprietary Name:
Omidria
Non-Proprietary Name:
Phenylephrine And Ketorolac
Substance Name:
Ketorolac; Phenylephrine
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.
11-Digit NDC Billing Format:
82604060000
NDC to 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rayner Surgical Inc.
    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(s):
  • Intraocular - Administration within the eye.
    • Active Ingredient(s):
  • KETOROLAC 2.88 mg/mL
  • PHENYLEPHRINE 10.16 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Anti-Inflammatory Agents, Non-Steroidal - [CS]
  • Cyclooxygenase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA205388
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-01-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    82604-600-044 VIAL in 1 CARTON / 4 mL in 1 VIAL
    82604-600-994 VIAL in 1 CARTON / 4 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 82604-600-00?

    The NDC Packaged Code 82604-600-00 is assigned to a package of 1 vial in 1 carton / 4 ml in 1 vial of Omidria, a human prescription drug labeled by Rayner Surgical Inc.. The product's dosage form is injection, solution, concentrate and is administered via intraocular form.

    Is NDC 82604-600 included in the NDC Directory?

    Yes, Omidria with product code 82604-600 is active and included in the NDC Directory. The product was first marketed by Rayner Surgical Inc. on July 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 82604-600-00?

    The 11-digit format is 82604060000. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-282604-600-005-4-282604-0600-00