Verkazia Emulsion
NDC Package 82667-014-01

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

Verkazia (cyclosporine) emulsions is cyclosporine eye drops are used to treat a certain type of dry eyes. This formulation utilizes a emulsion delivery system. Marketed by Harrow Eye, Llc, this product is identified by NDC 82667-014 and is authorized under FDA application NDA214965.

Identification & Billing

NDC Package Code
82667-014-01
Package Description
24 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE
Product Code
82667-014
11-Digit Billing Format
82667001401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Verkazia
Non-Proprietary Name
Cyclosporine
Substance Name
Cyclosporine
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route
  • Ophthalmic - Administration to the external eye.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
CYCLOSPORINE 1 mg/mL
Pharmacologic Class
Usage Information
Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.

Regulatory & Marketing

Labeler Name
Harrow Eye, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA214965
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-01-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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 (82667-014). Click a package code to view its specific billing and regulatory data.

82667-014-00
5 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE

* 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 82667-014-01 identifies a specific commercial package of 24 pouch in 1 carton / 5 vial, single-dose in 1 pouch / .3 ml in 1 vial, single-dose of Verkazia, a human prescription drug labeled by Harrow Eye, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This emulsion is formulated for ophthalmic; topical use and contains cyclosporine 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 February 01, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82667001401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
82667-014-01
11-Digit CMS (5-4-2)
82667-0014-01

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