Ofloxacin
NDC Package 71209-002-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ofloxacin is a medication used to treat eye infections. Marketed by Cadila Pharmaceuticals Limited, this product is identified by NDC 71209-002 and is authorized under FDA application ANDA091656.

Identification & Billing

NDC Package Code
71209-002-10
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
71209-002
11-Digit Billing Format
71209000210

Clinical Specifications

Proprietary Name
Ofloxacin
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Cadila Pharmaceuticals Limited
FDA Application #
ANDA091656
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-2015
End Marketing Date
01-09-2019
Listing Expiration
01-09-2019
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71209-002). Click a package code to view its specific billing and regulatory data.

71209-002-02
50 TABLET, FILM COATED in 1 BOTTLE
71209-002-05
100 TABLET, FILM COATED in 1 BOTTLE

* 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 71209-002-10 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Ofloxacin, labeled by Cadila Pharmaceuticals Limited. 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 Cadila Pharmaceuticals Limited on December 29, 2015. The current certification is valid through January 09, 2019.

What are the primary indications for this medication?

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.

How is this Cadila Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71209000210. 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)
71209-002-10
11-Digit CMS (5-4-2)
71209-0002-10

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