Tobramycin And Dexamethasone
NDC Package 68071-2772-2

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.

Tobramycin And Dexamethasone is iNDICATIONS AND USAGE: 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. Marketed by Nucare Pharmaceuticasl,inc., this product is identified by NDC 68071-2772 and is authorized under FDA application ANDA212715.

Identification & Billing

NDC Package Code
68071-2772-2
Package Description
2.5 mL in 1 BOTTLE, PLASTIC
Product Code
68071-2772
11-Digit Billing Format
68071277202
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
Dosage Form
-
Usage Information
INDICATIONS AND USAGE: 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. 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
Nucare Pharmaceuticasl,inc.
FDA Application #
ANDA212715
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-17-2022
Listing Expiration
12-31-2024
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 68071-2772-2 identifies a specific commercial package of 2.5 ml in 1 bottle, plastic of Tobramycin And Dexamethasone, labeled by Nucare Pharmaceuticasl,inc.. 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 Nucare Pharmaceuticasl,inc. on March 17, 2022. The current certification is valid through December 31, 2024.

How is this Nucare Pharmaceuticasl,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071277202. 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)
68071-2772-2
11-Digit CMS (5-4-2)
68071-2772-02

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