Betoptic S Suspension/ Drops
NDC Package 0078-0729-10

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

Betoptic S (betaxolol hydrochloride) suspension/ dropses is a medication used alone or with other medications to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.g., ocular hypertension). This formulation utilizes a suspension/ drops delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0729 and is authorized under FDA application NDA019845.

Identification & Billing

NDC Package Code
0078-0729-10
Package Description
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code
0078-0729
11-Digit Billing Format
00078072910
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 213729 - Betoptic S 0.25 % Ophthalmic Suspension
  • RxCUI: 213729 - betaxolol 2.5 MG/ML Ophthalmic Suspension [Betoptic S]
  • RxCUI: 213729 - Betoptic S 2.5 MG/ML (betaxolol hydrochloride 2.8 MG/ML) Ophthalmic Suspension
  • RxCUI: 308719 - betaxolol HCl 0.25 % Ophthalmic Suspension
  • RxCUI: 308719 - betaxolol 2.5 MG/ML Ophthalmic Suspension

Clinical Specifications

Proprietary Name
Betoptic S
Non-Proprietary Name
Betaxolol Hydrochloride
Substance Name
Betaxolol Hydrochloride
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
BETAXOLOL HYDROCHLORIDE 2.8 mg/mL
Pharmacologic Class
Usage Information
This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. Betaxolol belongs to a class of drugs known as beta blockers and works by decreasing the amount of fluid that is made within the eye.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA019845
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-15-1996
End Marketing Date
11-30-2026
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 (0078-0729). Click a package code to view its specific billing and regulatory data.

0078-0729-15
1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

* 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 0078-0729-10 identifies a specific commercial package of 1 bottle in 1 carton / 10 ml in 1 bottle of Betoptic S, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This suspension/ 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 Novartis Pharmaceuticals Corporation on January 15, 1996.

What are the primary indications for this medication?

This medication is used alone or with other medications to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. Betaxolol belongs to a class of drugs known as beta blockers and works by decreasing the amount of fluid that is made within the eye.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078072910. 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 (4-4-2)
0078-0729-10
11-Digit CMS (5-4-2)
00078-0729-10

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