Tobradex
NDC Package 21695-628-35

11-digit billing NDC: 21695062835 · Billing unit: GM · 3.5 GM per package
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 (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. 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
TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

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.

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.