NDC 62225-600-04 Omidria

Phenylephrine And Ketorolac

NDC Package Code 62225-600-04

The NDC Code 62225-600-04 is assigned to a package of 4 vial in 1 carton > 4 ml in 1 vial of Omidria, a human prescription drug labeled by Omeros Corporation. The product's dosage form is injection, solution, concentrate and is administered via intraocular form.

Field Name Field Value
NDC Code 62225-600-04
Package Description 4 VIAL in 1 CARTON > 4 mL in 1 VIAL
Proprietary Name Omidria What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Phenylephrine And Ketorolac What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 62225060004 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Omeros Corporation
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)
  • PHENYLEPHRINE 10.16 mg/mL
  • KETOROLAC 2.88 mg/mL
Pharmacological Class(es)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Nonsteroidal Anti-inflammatory Compounds - [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
  • Cyclooxygenase Inhibitor - [EPC] (Established Pharmacologic Class)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NDA205388 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 06-13-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

NDC Code Structure

  • 62225 - Omeros Corporation
    • 62225-600 - Omidria
      • 62225-600-04 - 4 VIAL in 1 CARTON

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 Omidria with product NDC 62225-600.

NDC Package CodePackage Description
62225-600-001 VIAL in 1 CARTON > 4 mL in 1 VIAL
62225-600-1010 VIAL in 1 CARTON > 4 mL in 1 VIAL
62225-600-994 VIAL in 1 CARTON > 4 mL in 1 VIAL

* Please review the disclaimer below.

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