Ciprofloxacin Hydrochloride
NDC Package 53401-005-20

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 Hydrochloride is ciprofloxacin tablets, USP are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Marketed by Testpak Holding Company, this product is identified by NDC 53401-005 and is authorized under FDA application ANDA076794.

Identification & Billing

NDC Package Code
53401-005-20
Package Description
20 TABLET, COATED in 1 BOTTLE
Product Code
53401-005
11-Digit Billing Format
53401000520
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ciprofloxacin Hydrochloride
Dosage Form
-
Usage Information
Ciprofloxacin tablets, USP are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATIONfor specific recommendations.

Regulatory & Marketing

Labeler Name
Testpak Holding Company
FDA Application #
ANDA076794
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-03-2009
Listing Expiration
12-31-2017
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 53401-005-20 identifies a specific commercial package of 20 tablet, coated in 1 bottle of Ciprofloxacin Hydrochloride, labeled by Testpak Holding Company. 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 Testpak Holding Company on December 03, 2009. The current certification is valid through December 31, 2017.

How is this Testpak Holding Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53401000520. 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)
53401-005-20
11-Digit CMS (5-4-2)
53401-0005-20

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