Tobramycin And Dexamethasone Suspension/ Drops
NDC Package 80425-0366-1

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

Package Information

Tobramycin And Dexamethasone suspension/ dropses is tobramycin and dexamethasone ophthalmic suspension 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. This formulation utilizes a suspension/ drops delivery system. Marketed by Advanced Rx Of Tennessee, Llc, this product is identified by NDC 80425-0366 and is authorized under FDA application NDA050592.

Identification & Billing

NDC Package Code
80425-0366-1
Package Description
5 mL in 1 BOTTLE
Product Code
80425-0366
11-Digit Billing Format
80425036601
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk
  • RxCUI: 309683 - tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Suspension
  • RxCUI: 309683 - dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension
  • RxCUI: 309683 - dexamethasone 0.1 % / tobramycin 0.3 % Ophthalmic Suspension

Clinical Specifications

Proprietary Name
Tobramycin And Dexamethasone
Non-Proprietary Name
Tobramycin And Dexamethasone
Substance Name
Dexamethasone; Tobramycin
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Tobramycin and dexamethasone ophthalmic suspension 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. aureusand 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 vulgarisstrains, Haemophilus influenzaeand H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticusand some Neisseriaspecies.

Regulatory & Marketing

Labeler Name
Advanced Rx Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA050592
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
11-02-2023
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 80425-0366-1 identifies a specific commercial package of 5 ml in 1 bottle of Tobramycin And Dexamethasone, a human prescription drug labeled by Advanced Rx Of Tennessee, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. This suspension/ drops is formulated for ophthalmic use and contains dexamethasone; 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 Advanced Rx Of Tennessee, Llc on November 02, 2023. The current certification is valid through December 31, 2026.

How is this Advanced Rx Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425036601. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 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 (5-4-1)
80425-0366-1
11-Digit CMS (5-4-2)
80425-0366-01

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