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  5. NDC Package Code: 61314-245-01 Betaxolol Hydrochloride

NDC Package 61314-245-01 Betaxolol Hydrochloride

Solution/ Drops Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
61314-245-01
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
Product Code:
61314-245
Proprietary Name:
Betaxolol Hydrochloride
Non-Proprietary Name:
Betaxolol Hydrochloride
Substance Name:
Betaxolol Hydrochloride
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.
11-Digit NDC Billing Format:
61314024501
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 308720 - betaxolol HCl 0.5 % Ophthalmic Solution
  • RxCUI: 308720 - betaxolol 5 MG/ML Ophthalmic Solution
  • RxCUI: 308720 - betaxolol 0.5 % Ophthalmic Solution
  • RxCUI: 308720 - betaxolol 5 MG/ML (betaxolol hydrochloride 5.6 MG/ML) Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • BETAXOLOL HYDROCHLORIDE 5.6 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic beta-Antagonists - [MoA] (Mechanism of Action)
  • beta-Adrenergic Blocker - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    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 Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    61314-245-021 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC
    61314-245-031 BOTTLE, PLASTIC in 1 CARTON / 10 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 61314-245-01?

    The NDC Packaged Code 61314-245-01 is assigned to a 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. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 61314-245 included in the NDC Directory?

    Yes, Betaxolol Hydrochloride with product code 61314-245 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on May 15, 2000 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 61314-245-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 61314-245-01?

    The 11-digit format is 61314024501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-261314-245-015-4-261314-0245-01