Ofloxacin
NDC Package 61314-015-10

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 Sandoz Inc, this product is identified by NDC 61314-015 and is authorized under FDA application ANDA078222.

Identification & Billing

NDC Package Code
61314-015-10
Package Description
10 mL in 1 BOTTLE
Product Code
61314-015
11-Digit Billing Format
61314001510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML

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
Sandoz Inc
FDA Application #
ANDA078222
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-31-2008
End Marketing Date
10-31-2018
Listing Expiration
10-31-2018
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 (61314-015). Click a package code to view its specific billing and regulatory data.

61314-015-05
5 mL 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 61314-015-10 identifies a specific commercial package of 10 ml in 1 bottle of Ofloxacin, labeled by Sandoz Inc. 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 Sandoz Inc on March 31, 2008. The current certification is valid through October 31, 2018.

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 Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61314001510. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 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)
61314-015-10
11-Digit CMS (5-4-2)
61314-0015-10

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