Gatifloxacin Powder
NDC Package 53476-1155-2

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Gatifloxacin powders is a medication a quinolone antibiotic used for eye infections (such as conjunctivitis). This formulation utilizes a powder delivery system. Marketed by Kyorin Pharmaceutical Group Facility Co., Ltd., this product is identified by NDC 53476-1155.

Identification & Billing

NDC Package Code
53476-1155-2
Package Description
1 BAG in 1 DRUM / 40 kg in 1 BAG
Product Code
53476-1155
11-Digit Billing Format
53476115502

Clinical Specifications

Proprietary Name
Gatifloxacin
Non-Proprietary Name
Gatifloxacin
Substance Name
Gatifloxacin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
GATIFLOXACIN 1 kg/kg
Usage Information
This medication is a quinolone antibiotic used for eye infections (such as conjunctivitis). This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Kyorin Pharmaceutical Group Facility Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-11-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 53476-1155-2 identifies a specific commercial package of 1 bag in 1 drum / 40 kg in 1 bag of Gatifloxacin (UNFINISHED drug), a bulk ingredient labeled by Kyorin Pharmaceutical Group Facility Co., Ltd.. This powder is formulated for use and contains gatifloxacin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kyorin Pharmaceutical Group Facility Co., Ltd. on July 11, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a quinolone antibiotic used for eye infections (such as conjunctivitis). This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Kyorin Pharmaceutical Group Facility Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53476115502. 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 (5-4-1)
53476-1155-2
11-Digit CMS (5-4-2)
53476-1155-02

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