NDC Package 68083-416-01 Levofloxacin

Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
68083-416-01
Package Description:
1 BAG in 1 POUCH / 150 mL in 1 BAG
Product Code:
Proprietary Name:
Levofloxacin
Non-Proprietary Name:
Levofloxacin
Substance Name:
Levofloxacin
Usage Information:
Levofloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
11-Digit NDC Billing Format:
68083041601
NDC to RxNorm Crosswalk:
  • RxCUI: 1665497 - levoFLOXacin 250 MG in 50 ML Injection
  • RxCUI: 1665497 - 50 ML levofloxacin 5 MG/ML Injection
  • RxCUI: 1665497 - levofloxacin 250 MG per 50 ML Injection
  • RxCUI: 1665507 - levoFLOXacin 500 MG in 100 ML Injection
  • RxCUI: 1665507 - 100 ML levofloxacin 5 MG/ML Injection
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Gland Pharma Limited
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA206908
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-30-2020
    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 68083-416-01?

    The NDC Packaged Code 68083-416-01 is assigned to a package of 1 bag in 1 pouch / 150 ml in 1 bag of Levofloxacin, a human prescription drug labeled by Gland Pharma Limited. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 68083-416 included in the NDC Directory?

    Yes, Levofloxacin with product code 68083-416 is active and included in the NDC Directory. The product was first marketed by Gland Pharma Limited on December 30, 2020 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 68083-416-01?

    The 11-digit format is 68083041601. 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
    5-3-268083-416-015-4-268083-0416-01