Betaxolol Hydrochloride Solution/ Drops
NDC Package 61314-245-01

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

Betaxolol Hydrochloride solution/ dropses is betaxolol Hydrochloride 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. This formulation utilizes a solution/ drops delivery system. Marketed by Sandoz Inc, this product is identified by NDC 61314-245 and is authorized under FDA application NDA019270.

Identification & Billing

NDC Package Code
61314-245-01
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
Product Code
61314-245
11-Digit Billing Format
61314024501
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 Hydrochloride
Non-Proprietary Name
Betaxolol Hydrochloride
Substance Name
Betaxolol Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
BETAXOLOL HYDROCHLORIDE 5.6 mg/mL
Pharmacologic Class
Usage Information
Betaxolol Hydrochloride 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 Hydrochloride 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
Sandoz Inc
Product Type
Human Prescription Drug
FDA Application #
NDA019270
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
05-15-2000
Listing Expiration
12-31-2026
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 (61314-245). Click a package code to view its specific billing and regulatory data.

61314-245-02
1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC
61314-245-03
1 BOTTLE, PLASTIC in 1 CARTON / 10 mL in 1 BOTTLE, PLASTIC

* 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 61314-245-01 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic of Betaxolol Hydrochloride, a human prescription drug labeled by Sandoz Inc. This solution/ drops is formulated for ophthalmic use and contains betaxolol 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 Sandoz Inc on May 15, 2000. The current certification is valid through December 31, 2026.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314024501. 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)
61314-245-01
11-Digit CMS (5-4-2)
61314-0245-01

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