Gentamicin Sulfate Powder
NDC Package 48866-8256-5

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.

Gentamicin Sulfate powders is a medication used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). This formulation utilizes a powder delivery system. Marketed by Lek Pharmaceuticals, D.d., this product is identified by NDC 48866-8256.

Identification & Billing

NDC Package Code
48866-8256-5
Package Description
10 kg in 1 DRUM
Product Code
48866-8256
11-Digit Billing Format
48866825605

Clinical Specifications

Proprietary Name
Gentamicin Sulfate
Non-Proprietary Name
Gentamicin Sulfate
Substance Name
Gentamicin
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)
GENTAMICIN 10 kg/10kg
Usage Information
This medication is used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). It is also used to prevent infection after eye injury or surgery. It belongs to a class of drugs known as aminoglycoside antibiotics. Gentamicin works by killing the bacteria. 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
Lek Pharmaceuticals, D.d.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
07-12-2013
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 48866-8256-5 identifies a specific commercial package of 10 kg in 1 drum of Gentamicin Sulfate (UNFINISHED drug), a bulk ingredient labeled by Lek Pharmaceuticals, D.d.. This powder is formulated for use and contains gentamicin 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 Lek Pharmaceuticals, D.d. on July 12, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat bacterial infections (such as blepharitis, conjunctivitis) of the eye and the skin around the eyes (such as eyelids). It is also used to prevent infection after eye injury or surgery. It belongs to a class of drugs known as aminoglycoside antibiotics. Gentamicin works by killing the bacteria. 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 Lek Pharmaceuticals, D.d. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48866825605. 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)
48866-8256-5
11-Digit CMS (5-4-2)
48866-8256-05

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