Gentamicin Sulfate Ointment
NDC Package 0713-0682-15

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

Gentamicin Sulfate ointment 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 ointment delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0682 and is authorized under FDA application ANDA064054.

Identification & Billing

NDC Package Code
0713-0682-15
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE
Product Code
0713-0682
11-Digit Billing Format
00713068215
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
15 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gentamicin Sulfate
Non-Proprietary Name
Gentamicin Sulfate
Substance Name
Gentamicin Sulfate
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
GENTAMICIN SULFATE 1 mg/g
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
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA064054
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-28-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0713-0682). Click a package code to view its specific billing and regulatory data.

0713-0682-31
1 TUBE in 1 CARTON / 30 g in 1 TUBE

* 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 0713-0682-15 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube of Gentamicin Sulfate, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This ointment is formulated for topical 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 Cosette Pharmaceuticals, Inc. on November 28, 2014. 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 Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713068215. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 15 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 (4-4-2)
0713-0682-15
11-Digit CMS (5-4-2)
00713-0682-15

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