1. Home
  2. Labeler Index
  3. Leading Pharma, Llc
  4. 69315-320
  5. NDC Package Code: 69315-320-05 Ofloxacin

NDC Package 69315-320-05 Ofloxacin

Solution Auricular (otic) - 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:
69315-320-05
Package Description:
5 mL in 1 BOTTLE, DROPPER
Product Code:
69315-320
Proprietary Name:
Ofloxacin
Non-Proprietary Name:
Ofloxacin
Substance Name:
Ofloxacin
Usage Information:
This medication is used to treat eye infections. Ofloxacin belongs to a class of drugs called quinolone 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:
69315032005
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
5 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 242446 - ofloxacin 0.3 % Otic Solution
  • RxCUI: 242446 - ofloxacin 3 MG/ML Otic Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Leading Pharma, Llc
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Auricular (otic) - Administration to or by way of the ear.
    • Active Ingredient(s):
  • OFLOXACIN 3 mg/mL
    • Pharmacologic Class(es):
  • Quinolone Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Quinolones - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA217903
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-01-2024
    Listing Expiration Date:
    12-31-2025
    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
    69315-320-1010 mL in 1 BOTTLE, DROPPER

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69315-320-05?

    The NDC Packaged Code 69315-320-05 is assigned to a package of 5 ml in 1 bottle, dropper of Ofloxacin, a human prescription drug labeled by Leading Pharma, Llc. The product's dosage form is solution and is administered via auricular (otic) form.This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package.

    Is NDC 69315-320 included in the NDC Directory?

    Yes, Ofloxacin with product code 69315-320 is active and included in the NDC Directory. The product was first marketed by Leading Pharma, Llc on March 01, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 69315-320-05?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 5.

    What is the 11-digit format for NDC 69315-320-05?

    The 11-digit format is 69315032005. 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
    5-3-269315-320-055-4-269315-0320-05