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  5. NDC Package Code: 65145-144-01 Ofloxacin

NDC Package 65145-144-01 Ofloxacin

Ofloxacin Otic Solution Solution/ Drops Auricular (otic) - 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:
65145-144-01
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code:
65145-144
Proprietary Name:
Ofloxacin
Non-Proprietary Name:
Ofloxacin Otic Solution
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:
65145014401
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:
    Caplin Steriles Limited
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    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:
    01-09-2024
    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.

    Frequently Asked Questions

    What is NDC 65145-144-01?

    The NDC Packaged Code 65145-144-01 is assigned to a package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Ofloxacin, a human prescription drug labeled by Caplin Steriles Limited. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

    Is NDC 65145-144 included in the NDC Directory?

    Yes, Ofloxacin with product code 65145-144 is active and included in the NDC Directory. The product was first marketed by Caplin Steriles Limited on January 09, 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 11-digit format for NDC 65145-144-01?

    The 11-digit format is 65145014401. 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
    5-3-265145-144-015-4-265145-0144-01