Tobradex
NDC Package 21695-628-35

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tobradex is a medication used to treat or prevent eye infections. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-628 and is authorized under FDA application NDA050616.

Identification & Billing

NDC Package Code
21695-628-35
Package Description
3.5 g in 1 TUBE
Product Code
21695-628
11-Digit Billing Format
21695062835
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
  • RxCUI: 208821 - TobraDex 0.3 % / 0.1 % Ophthalmic Ointment
  • RxCUI: 208821 - dexamethasone 0.001 MG/MG / tobramycin 0.003 MG/MG Ophthalmic Ointment [Tobradex]
  • RxCUI: 208821 - Tobradex (tobramycin 0.3 % / dexamethasone 0.1 % ) Ophthalmic Ointment
  • RxCUI: 309682 - tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Ointment
  • RxCUI: 309682 - dexamethasone 0.001 MG/MG / tobramycin 0.003 MG/MG Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Tobradex
Dosage Form
-
Usage Information
This medication is used to treat or prevent eye infections. This medication contains two drugs. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. Dexamethasone belongs to a class of drugs called corticosteroids. It works by reducing swelling. This medication treats/prevents 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
Rebel Distributors Corp
FDA Application #
NDA050616
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-28-1988
Listing Expiration
12-31-2017
Exclude Flag
I
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 21695-628-35 identifies a specific commercial package of 3.5 g in 1 tube of Tobradex, labeled by Rebel Distributors Corp. This product is billed per "GM" gram and contains an estimated amount of 3.5 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rebel Distributors Corp on September 28, 1988. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat or prevent eye infections. This medication contains two drugs. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. Dexamethasone belongs to a class of drugs called corticosteroids. It works by reducing swelling. This medication treats/prevents 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 Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695062835. 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 (5-3-2)
21695-628-35
11-Digit CMS (5-4-2)
21695-0628-35

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