Betaxolol
NDC Package 17478-705-10

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Betaxolol is ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. Marketed by Akorn, this product is identified by NDC 17478-705 and is authorized under FDA application ANDA075386.

Identification & Billing

NDC Package Code
17478-705-10
Package Description
1 VIAL in 1 CARTON / 5 mL in 1 VIAL
Product Code
17478-705
11-Digit Billing Format
17478070510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Betaxolol
Dosage Form
-
Usage Information
Betaxolol Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, betaxolol ophthalmic solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.

Regulatory & Marketing

Labeler Name
Akorn
FDA Application #
ANDA075386
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2003
Listing Expiration
12-31-2023
Exclude Flag
I
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 (17478-705). Click a package code to view its specific billing and regulatory data.

17478-705-11
1 VIAL in 1 CARTON / 10 mL in 1 VIAL
17478-705-12
1 VIAL in 1 CARTON / 15 mL in 1 VIAL
17478-705-25
1 VIAL in 1 CARTON / 2.5 mL 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 17478-705-10 identifies a specific commercial package of 1 vial in 1 carton / 5 ml in 1 vial of Betaxolol, labeled by Akorn. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Akorn on April 01, 2003. The current certification is valid through December 31, 2023.

How is this Akorn product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17478070510. 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)
17478-705-10
11-Digit CMS (5-4-2)
17478-0705-10

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