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  5. NDC Package Code: 68083-457-01 Timolol Maleate Ophthalmic Gel Forming Solution

NDC Package 68083-457-01 Timolol Maleate Ophthalmic Gel Forming Solution

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

Table of Contents

    1. Package Information
    2. 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:
68083-457-01
Package Description:
1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE
Product Code:
68083-457
Proprietary Name:
Timolol Maleate Ophthalmic Gel Forming Solution
Non-Proprietary Name:
Timolol Maleate Ophthalmic Gel Forming Solution
Substance Name:
Timolol Maleate
Usage Information:
This medication is used 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. This medication works by decreasing the amount of fluid within the eye. Timolol belongs to a class of drugs known as beta-blockers.
11-Digit NDC Billing Format:
68083045701
NDC to RxNorm Crosswalk:
  • RxCUI: 313407 - timolol maleate 0.25 % Ophthalmic Gel Forming Solution
  • RxCUI: 313407 - timolol 0.0025 MG/MG Ophthalmic Gel
  • RxCUI: 313407 - timolol 0.25 % Ophthalmic Gel
  • RxCUI: 313407 - timolol 0.25 % Ophthalmic Gel Forming Solution
  • RxCUI: 313408 - timolol maleate 0.5 % Ophthalmic Gel Forming Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    Dosage Form:
    Solution, Gel Forming / Drops - A solution, which after usually being administered in a drop-wise fashion, forms a gel.
    Administration Route(s):
  • Ophthalmic - Administration to the external eye.
    • Active Ingredient(s):
  • TIMOLOL MALEATE 2.5 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:
    ANDA214645
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-24-2022
    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.

    Frequently Asked Questions

    What is NDC 68083-457-01?

    The NDC Packaged Code 68083-457-01 is assigned to a package of 1 bottle in 1 carton / 5 ml in 1 bottle of Timolol Maleate Ophthalmic Gel Forming Solution, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is solution, gel forming / drops and is administered via ophthalmic form.

    Is NDC 68083-457 included in the NDC Directory?

    Yes, Timolol Maleate Ophthalmic Gel Forming Solution with product code 68083-457 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on June 24, 2022 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 11-digit format for NDC 68083-457-01?

    The 11-digit format is 68083045701. 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
    5-3-268083-457-015-4-268083-0457-01