Tobradex St Suspension/ Drops
NDC Package 71776-035-01

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

Tobradex St (tobramycin / dexamethasone) suspension/ dropses is a medication used to treat or prevent eye infections. This formulation utilizes a suspension/ drops delivery system. Marketed by Eyevance Pharmaceuticals, Llc, this product is identified by NDC 71776-035 and is authorized under FDA application NDA050818.

Identification & Billing

NDC Package Code
71776-035-01
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 1 mL in 1 BOTTLE, DROPPER
Product Code
71776-035
11-Digit Billing Format
71776003501
RxNorm Crosswalk
  • RxCUI: 1011080 - TobraDex ST 0.3 % / 0.05 % Ophthalmic Suspension
  • RxCUI: 1011080 - dexamethasone 0.5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [Tobradex]
  • RxCUI: 1011080 - Tobradex (dexamethasone 0.05 % / tobramycin 0.3 % ) Ophthalmic Suspension
  • RxCUI: 849115 - tobramycin 0.3 % / dexAMETHasone 0.05 % Ophthalmic Suspension
  • RxCUI: 849115 - dexamethasone 0.5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension

Clinical Specifications

Proprietary Name
Tobradex St
Non-Proprietary Name
Tobramycin / 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
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
Eyevance Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA050818
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-19-2021
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 (71776-035). Click a package code to view its specific billing and regulatory data.

71776-035-05
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

* 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 71776-035-01 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 1 ml in 1 bottle, dropper of Tobradex St, a human prescription drug labeled by Eyevance Pharmaceuticals, Llc. 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 Eyevance Pharmaceuticals, Llc on May 19, 2021. The current certification is valid through December 31, 2026.

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 Eyevance Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71776003501. 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)
71776-035-01
11-Digit CMS (5-4-2)
71776-0035-01

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