Ciprofloxacin Otic
NDC Package 42195-550-14

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ciprofloxacin Otic is solution is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus. Marketed by Xspire Pharma, Llc, this product is identified by NDC 42195-550 and is authorized under FDA application NDA021918.

Identification & Billing

NDC Package Code
42195-550-14
Package Description
14 CONTAINER in 1 CARTON / .25 mL in 1 CONTAINER
Product Code
42195-550
11-Digit Billing Format
42195055014
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ciprofloxacin Otic
Dosage Form
-
Usage Information
Ciprofloxacin Otic Solution is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.

Regulatory & Marketing

Labeler Name
Xspire Pharma, Llc
FDA Application #
NDA021918
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-27-2012
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42195-550-14 identifies a specific commercial package of 14 container in 1 carton / .25 ml in 1 container of Ciprofloxacin Otic, labeled by Xspire Pharma, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Xspire Pharma, Llc on August 27, 2012. The current certification is valid through December 31, 2025.

How is this Xspire Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42195055014. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
42195-550-14
11-Digit CMS (5-4-2)
42195-0550-14

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.