Tobramycin Injection, Solution
NDC Package 63323-306-55

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

Tobramycin (tobramycin sulfate) injection is a medication used to treat eye infections. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-306 and is authorized under FDA application ANDA065122.

Identification & Billing

NDC Package Code
63323-306-55
Package Description
25 VIAL in 1 TRAY / 2 mL in 1 VIAL
Product Code
63323-306
11-Digit Billing Format
63323030655
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Tobramycin
Non-Proprietary Name
Tobramycin Sulfate
Substance Name
Tobramycin Sulfate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
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
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065122
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-23-2005
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 (63323-306). Click a package code to view its specific billing and regulatory data.

63323-306-02
25 VIAL, MULTI-DOSE in 1 TRAY / 2 mL in 1 VIAL, MULTI-DOSE (63323-306-01)
63323-306-26
25 VIAL, MULTI-DOSE in 1 TRAY / 2 mL in 1 VIAL, MULTI-DOSE
63323-306-30
10 VIAL, MULTI-DOSE in 1 TRAY / 30 mL in 1 VIAL, MULTI-DOSE (63323-306-05)
63323-306-56
10 VIAL in 1 TRAY / 30 mL in 1 VIAL

* 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 63323-306-55 identifies a specific commercial package of 25 vial in 1 tray / 2 ml in 1 vial of Tobramycin, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution 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 Fresenius Kabi Usa, Llc on November 23, 2005. 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 Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323030655. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
63323-306-55
11-Digit CMS (5-4-2)
63323-0306-55

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