Tobramycin Injection
NDC Package 67457-428-30

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

Package Information

Tobramycin injection is a medication used to treat eye infections. This formulation utilizes a injection delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 67457-428 and is authorized under FDA application ANDA065407.

Identification & Billing

NDC Package Code
67457-428-30
Package Description
10 VIAL in 1 CARTON / 30 mL in 1 VIAL (67457-428-00)
Product Code
67457-428
11-Digit Billing Format
67457042830
RxNorm Crosswalk
  • RxCUI: 597823 - tobramycin 40 MG/ML Injectable Solution
  • RxCUI: 597823 - tobramycin (as tobramycin sulfate) 40 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Tobramycin
Non-Proprietary Name
Tobramycin
Substance Name
Tobramycin Sulfate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TOBRAMYCIN SULFATE 40 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. This medication treats 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
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065407
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-19-2014
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 67457-428-30 identifies a specific commercial package of 10 vial in 1 carton / 30 ml in 1 vial (67457-428-00) of Tobramycin, a human prescription drug labeled by Mylan Institutional Llc. This injection is formulated for intramuscular; intravenous use and contains tobramycin sulfate 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 Mylan Institutional Llc on February 19, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat eye infections. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. This medication treats 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 Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67457042830. 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)
67457-428-30
11-Digit CMS (5-4-2)
67457-0428-30

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