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  5. NDC Package Code: 0078-0799-75 Ciprodex

NDC Package 0078-0799-75 Ciprodex

Ciprofloxacin And Dexamethasone Suspension/ 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:
0078-0799-75
Package Description:
1 BOTTLE in 1 CARTON / 7.5 mL in 1 BOTTLE
Product Code:
0078-0799
Proprietary Name:
Ciprodex
Non-Proprietary Name:
Ciprofloxacin And Dexamethasone
Substance Name:
Ciprofloxacin Hydrochloride; Dexamethasone
Usage Information:
This medication is used to treat bacterial ear infections. It is used to treat middle ear infections in children with ear tubes, as well as outer ear infections (also known as swimmer's ear) in children and adults. This medication contains a combination of ciprofloxacin (a quinolone-type antibiotic) and dexamethasone (an anti-inflammatory corticosteroid). This ear drop works by stopping the growth of bacteria and reducing ear swelling and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
11-Digit NDC Billing Format:
00078079975
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic Suspension
  • RxCUI: 404630 - CIPRODEX 0.3 % / 0.1 % Otic Suspension
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Novartis Pharmaceuticals Corporation
    Dosage Form:
    Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
    Administration Route(s):
  • Auricular (otic) - Administration to or by way of the ear.
    • Active Ingredient(s):
  • CIPROFLOXACIN HYDROCHLORIDE 3 mg/mL
  • DEXAMETHASONE 1 mg/mL
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)
  • Fluoroquinolone Antibacterial - [EPC] (Established Pharmacologic Class)
  • Fluoroquinolones - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA021537
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-04-2003
    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 0078-0799-75?

    The NDC Packaged Code 0078-0799-75 is assigned to a package of 1 bottle in 1 carton / 7.5 ml in 1 bottle of Ciprodex, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is suspension/ drops and is administered via auricular (otic) form.

    Is NDC 0078-0799 included in the NDC Directory?

    Yes, Ciprodex with product code 0078-0799 is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on August 04, 2003 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 NDC billing unit for package 0078-0799-75?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0078-0799-75?

    The 11-digit format is 00078079975. 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 4-4-2 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
    4-4-20078-0799-755-4-200078-0799-75