Akten Gel
NDC Package 82584-792-01

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

Akten (lidocaine hydrochloride anhydrous) gel is aKTEN ® is indicated for ocular surface anesthesia during ophthalmologic procedures. This formulation utilizes a gel delivery system. Marketed by Thea Pharma Inc., this product is identified by NDC 82584-792 and is authorized under FDA application NDA022221.

Identification & Billing

NDC Package Code
82584-792-01
Package Description
1 TUBE in 1 CARTON / 1 mL in 1 TUBE
Product Code
82584-792
11-Digit Billing Format
82584079201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Akten
Non-Proprietary Name
Lidocaine Hydrochloride Anhydrous
Substance Name
Lidocaine Hydrochloride Anhydrous
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)
LIDOCAINE HYDROCHLORIDE ANHYDROUS 35 mg/mL
Pharmacologic Class
Usage Information
AKTEN ® is indicated for ocular surface anesthesia during ophthalmologic procedures.

Regulatory & Marketing

Labeler Name
Thea Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022221
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-01-2022
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 (82584-792). Click a package code to view its specific billing and regulatory data.

82584-792-25
25 TUBE in 1 CARTON / 1 mL in 1 TUBE

* 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 82584-792-01 identifies a specific commercial package of 1 tube in 1 carton / 1 ml in 1 tube of Akten, a human prescription drug labeled by Thea Pharma Inc.. This gel is formulated for ophthalmic use and contains lidocaine hydrochloride anhydrous 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 Thea Pharma Inc. on December 01, 2022. The current certification is valid through December 31, 2027.

How is this Thea Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82584079201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
82584-792-01
11-Digit CMS (5-4-2)
82584-0792-01

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