Iheezo Gel
NDC Package 82667-300-00

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

Iheezo (chloroprocaine hydrochloride ophthalmic gel) gel is iHEEZO TM is indicated for ocular surface anesthesia. This formulation utilizes a gel delivery system. Marketed by Harrow Eye, Llc, this product is identified by NDC 82667-300 and is authorized under FDA application NDA216227.

Identification & Billing

NDC Package Code
82667-300-00
Package Description
1 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL
Product Code
82667-300
11-Digit Billing Format
82667030000
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Iheezo
Non-Proprietary Name
Chloroprocaine Hydrochloride Ophthalmic Gel
Substance Name
Chloroprocaine Hydrochloride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
CHLOROPROCAINE HYDROCHLORIDE 24 mg/800mg
Pharmacologic Class
Usage Information
IHEEZO TM is indicated for ocular surface anesthesia.

Regulatory & Marketing

Labeler Name
Harrow Eye, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA216227
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-27-2022
Listing Expiration
12-31-2027
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 (82667-300). Click a package code to view its specific billing and regulatory data.

82667-300-01
1 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL
82667-300-05
5 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 800 mg 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 82667-300-00 identifies a specific commercial package of 1 pouch in 1 carton / 1 vial in 1 pouch / 800 mg in 1 vial of Iheezo, a human prescription drug labeled by Harrow Eye, Llc. This gel is formulated for ophthalmic use and contains chloroprocaine hydrochloride 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 Harrow Eye, Llc on September 27, 2022. The current certification is valid through December 31, 2027.

How is this Harrow Eye, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82667030000. 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)
82667-300-00
11-Digit CMS (5-4-2)
82667-0300-00

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