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  5. NDC Package Code: 68083-374-01 Tobramycin

NDC Package 68083-374-01 Tobramycin

Solution/ 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:
68083-374-01
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
Product Code:
68083-374
Proprietary Name:
Tobramycin
Non-Proprietary Name:
Tobramycin
Substance Name:
Tobramycin
Usage Information:
This medication is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
11-Digit NDC Billing Format:
68083037401
NDC to RxNorm Crosswalk:
  • RxCUI: 313415 - tobramycin 0.3 % Ophthalmic Solution
  • RxCUI: 313415 - tobramycin 3 MG/ML Ophthalmic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    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):
  • TOBRAMYCIN 3 mg/mL
    • Pharmacologic Class(es):
  • Aminoglycoside Antibacterial - [EPC] (Established Pharmacologic Class)
  • Aminoglycosides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA212628
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-09-2021
    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 68083-374-01?

    The NDC Packaged Code 68083-374-01 is assigned to a package of 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic of Tobramycin, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is solution/ drops and is administered via ophthalmic form.

    Is NDC 68083-374 included in the NDC Directory?

    Yes, Tobramycin with product code 68083-374 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on March 09, 2021 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 68083-374-01?

    The 11-digit format is 68083037401. 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
    5-3-268083-374-015-4-268083-0374-01