Floxin Otic
NDC Package 63395-101-10

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.

Floxin Otic is a . Marketed by Daiichi Sankyo Pharma Development, this product is identified by NDC 63395-101 and is authorized under FDA application NDA020799.

Identification & Billing

NDC Package Code
63395-101-10
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
Product Code
63395-101
11-Digit Billing Format
63395010110

Clinical Specifications

Proprietary Name
Floxin Otic
Dosage Form
-

Regulatory & Marketing

Labeler Name
Daiichi Sankyo Pharma Development
FDA Application #
NDA020799
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-1998
End Marketing Date
12-31-2009
Listing Expiration
12-31-2009
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 (63395-101). Click a package code to view its specific billing and regulatory data.

63395-101-00
5 mL in 1 BOTTLE, DROPPER
63395-101-00
5 mL in 1 BOTTLE, DROPPER
63395-101-05
5 mL in 1 BOTTLE, DROPPER
63395-101-05
5 mL in 1 BOTTLE, DROPPER

* 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 63395-101-10 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Floxin Otic, labeled by Daiichi Sankyo Pharma Development. 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 Daiichi Sankyo Pharma Development on January 01, 1998. The current certification is valid through December 31, 2009.

How is this Daiichi Sankyo Pharma Development product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63395010110. 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)
63395-101-10
11-Digit CMS (5-4-2)
63395-0101-10

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