Tobrex Ointment
NDC Package 0078-0813-01

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

Package Information

Tobrex (tobramycin) ointment is a medication used to treat eye infections. This formulation utilizes a ointment delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0813 and is authorized under FDA application NDA050555.

Identification & Billing

NDC Package Code
0078-0813-01
Package Description
3.5 g in 1 TUBE
Product Code
0078-0813
11-Digit Billing Format
00078081301
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
3.5 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tobrex
Non-Proprietary Name
Tobramycin
Substance Name
Tobramycin
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
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
TOBRAMYCIN 3 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
Product Type
Human Prescription Drug
FDA Application #
NDA050555
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-28-1981
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 0078-0813-01 identifies a specific commercial package of 3.5 g in 1 tube of Tobrex, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This ointment is formulated for ophthalmic use and contains tobramycin 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 Novartis Pharmaceuticals Corporation on June 28, 1981. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078081301. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 3.5 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)
0078-0813-01
11-Digit CMS (5-4-2)
00078-0813-01

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