Gentamicin Sulfate Solution
NDC Package 68071-4775-5

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

Package Information

Gentamicin Sulfate solution 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 solution delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4775 and is authorized under FDA application ANDA062196.

Identification & Billing

NDC Package Code
68071-4775-5
Package Description
5 mL in 1 BOTTLE
Product Code
68071-4775
11-Digit Billing Format
68071477505
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gentamicin Sulfate
Non-Proprietary Name
Gentamicin Sulfate
Substance Name
Gentamicin Sulfate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
GENTAMICIN SULFATE 3 mg/mL
Pharmacologic Class
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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA062196
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-05-1996
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-4775-5 identifies a specific commercial package of 5 ml in 1 bottle of Gentamicin Sulfate, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This solution is formulated for ophthalmic use and contains gentamicin sulfate 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 Nucare Pharmaceuticals,inc. on April 05, 1996. 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 Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071477505. 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)
68071-4775-5
11-Digit CMS (5-4-2)
68071-4775-05

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