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  5. NDC Package Code: 42195-128-14 Ciprofloxacin And Fluocinolone Acetonide

NDC Package 42195-128-14 Ciprofloxacin And Fluocinolone Acetonide

Solution 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:
42195-128-14
Package Description:
1 POUCH in 1 CARTON / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE
Product Code:
42195-128
Proprietary Name:
Ciprofloxacin And Fluocinolone Acetonide
Non-Proprietary Name:
Ciprofloxacin And Fluocinolone Acetonide
Substance Name:
Ciprofloxacin; Fluocinolone Acetonide
Usage Information:
Ciprofloxacin and Fluocinolone Acetonide Otic Solution is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.
11-Digit NDC Billing Format:
42195012814
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1792386 - ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % Otic Solution
  • RxCUI: 1792386 - ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution
Product Type:
Human Prescription Drug
Labeler Name:
Xspire 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):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA208251
Marketing Category:
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date:
10-04-2021
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 42195-128-14?

The NDC Packaged Code 42195-128-14 is assigned to a package of 1 pouch in 1 carton / 14 vial, single-dose in 1 pouch / .25 ml in 1 vial, single-dose of Ciprofloxacin And Fluocinolone Acetonide, a human prescription drug labeled by Xspire Pharma, Llc. The product's dosage form is solution and is administered via auricular (otic) form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 42195-128 included in the NDC Directory?

Yes, Ciprofloxacin And Fluocinolone Acetonide with product code 42195-128 is active and included in the NDC Directory. The product was first marketed by Xspire Pharma, Llc on October 04, 2021 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 42195-128-14?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 42195-128-14?

The 11-digit format is 42195012814. 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
5-3-242195-128-145-4-242195-0128-14